Comments on the IIT Madras study- sponsored by

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nts on the IIT Madras study- sponsored by Chemicals Industry Association
Remarks
According to the Hazardous substance fact sheet, New Jersy Department of Health
and Senior Services, 1,4- Naphthalenedione has not been tested for its ability to
cause cancer in animals.
According to the Hazardous substance fact sheet, New Jersy Department of Health
and Senior Services, 1,4- Naphthalenedione has not been tested for its ability to
affect reproduction.

In the report "Substance Evaluation Conclusion document of Naphthalene",

results of a physiological- based pharmacokinetic model that shows that
naphthalene metabolism is approximately five times higher in the rat nose than in
humans and therefore, some doubts have been cast on the relevance of the rodent
data for humans a t typical human exposure concenterations (Bailey et al. 2015)

Regarding the human relevance; the mode of action of Naphthalene carcinogenesis

in animals is of no relevance of tumors to humans requires further consideration.
More study is needed.
There is no information availbale on humans through dermal exposure of
Naphthalene. Also, negative results obtained in the vivo genotoxic studies.
To summarize the conclusionof the "Naphthalene evaluation conclusion
documnet", there was no consistent pattern of inflammatory effect was seen,
either in moderately or high exposure. The harmonised classification of
Naphthalene for carcinogenicity was based on Nasal tumors and not applicable to
humans.

In the ESR review of Naphthalene (2003), they conclude that, no evidence of

Naphthalene effects through dermal exposure, inhalation and is acutely toxic.
Very little to no new information has emerged since the ESR review to shed further
light on a no-effect level for haemolytic anaemia in humans.
Through smell or odour is not a proper scientific way to determine the presence of
Naphthalene.
No information on carcinogenicity of Naphthalene in humans or animals following
oral exposure or by other routes was found. Information on chronic toxicity of
Naphthalene or reproductive toxicity of Naphthalene in humans or animals by
other routes of exposure in humans or animals was not availbale. Hence, the report
concluded that data is in sufficient to derive carcinogenicity slope factors for
Naphthalene.
The experiments done on rats showed, no carcinogenic responses werereported in
BDI and BD II rats, that received intraperitoneal injections of Napthalene (20
mg/rat) once weekly for 40 weeks (Schmahl, 1955).
There has been seen no death of any animal within a 14 day observation period
following applications of 2500 mg/kg of Naphthalene was directly applied to the
skin of rats and rabbits.
Information on the chronic oral toxicity of Naphthalene in humans was not
available.
The report states that no deaths have been reported from Naphthalene
US EPA (1991, 1992), based on the insufficient cancer bioassays, to assess the
carcinogenicity of Naphthalene has placed Naphthalene in weight -of -evidence
group D, which is not classifiable as to human carcinogenicity.
Available data are inadequate to establish a causal association between exposure
of Naphthalene and cancer in humans. Adequately, scaled epidemiological studies
designe to examine a possible association between Naphthalene exposure and
cancer were not located.

The conclusion of the above paper states inadequacy and lack of evidence for
Naphthalene effects to humans.
The distribution, metabolism and excretion of tritiated Naphthalene given
intrapertioneally at a dose of 20 mg/kg bw. Approximately, 88% of the radioactivity
was excreted in urine. 68% and from faeces (20%) in the first 72 hrs.

There are no adequate chronic oral dose- response data for Naphthalene in
humans or animals.
Data for humans are inadequate to evaluate a plausible association with cancer.
The evidence is insufficient to assess the carcinogenic potential of Naphthalene in
humans.
Human experience with acute inhalation exposure and occupational exposure to
Naphthalene has identified hemolytic anemia and cataracts as effects of concern,
but there are inadequate human data to describe dose-response relationships for
these effects.

No association could be deduce with cancer occurrence and exposure.

No carcinogenic responses were observed in studies with rats treated with
Naphthalene in diet for more than 2 years or with repeated intraperitoneal or
subcutaneous injections.
Naphthalene is not genotoxic.
No tests has been done on humans.
In humans, Naphthalene has been found to cause hemolyte anemia and catract
formation at high concenterations.
Cancer to the group was due to smoking and not because of working/ occupational
exposure to Naphthalene
The majority of human deaths following Naphthalene intoxication have resulted
from intentional ingestion of moth balls
In humans, little information is available pertaining to the metabolism of
Naphthalene.
Tests have been only done on pigs, rats, dogs, mice and other small animals.
EPA proves Naphthalene is not carcinogenic.
No tests done on humans and no information available. And, from the other
reports of this study we concluded no effects to humans through dermal exposure.

PA and other plasticizers is not being listed as source of Naphthalene

First smoking is to be banned. As it has more Naphthalene content present in it and
is more hazardous to humans than PA.
US EPA not sure wheteher Naphthalene is carcinogenic or not.
O-xylene is toxic and is present in PA as unreacted (ppm level). It is also harmful in
contact with skin.
Naphthalene toxicokinetics information is not available. Also, no conclusion can be
drawn reg. the irritant properties of Naphthalene in humans.
The excretion of Naphthalene is rapid in humans and it does not accumulate in
body.
In cigarettes Naphthalene 12-54 micro gram of Naphthalene is present.
Rather than the presence of Naphthalene in PA or plasticizers (which is yet to be
proven), we should be more concern with the presence of Naphthalene which is
proven to be present in cigarettes and in CFL light bulbs.

Humans are more susceptible to Naphthalene effects through indirect exposure.

It is seen that Naphthalene has no combine effects, it is not neurotoxic,
immunotoxic, no effect DNA mutation, No effect to bacterial mutation and not an
endocrine disruptor.
Environment Canada (2008b) has reported that humans are affected more by
indirect exposure on Naphthalene than the direct exposure. Also, plastics are not a
source of Naphthalene exposure. Hence, PA or other plasticizers are less
susceptible to the source of Naphthalene exposure.

No relation is found with the fertility in humans.

Concluded by EU Risk assessment, that Naphthalene is not genotoxic (ECB,2003)
Data is limited on the chronic toxicity and carcinogenicity in humans.
EU risk assessment has concluded that it is not relevant to the effect seen in
rodents will be likely to humans.

In humans only few skin irritations have been reported. Also, these reports are
more than 60 years old. No, recent research done?
All of the agencies have carried out tests on rodents, rabbits, rats, fishes and dogs.
However, study done in 2014 shows that, the effect of Naphthalene to above
animals will not have likely resemblances to humans.
There is no information available on the effects of Naphthalene following acute
inhalation or dermal exposure in humans.
It is concluded by EU RAR, that rodents are not suitable animal species for the
acute toxic human health effects of Naphthalene in relation to haemolytic anaemia.

Not a lot of studies done to prove any serious effects of Naphthalene to humans.

From 1st Para, conclusion can be made that, humans are not affected by
Naphthalene present in PA, but through other sources such as traffic pollution,
cigarette smoke, moth balls and working in Naphthalenephthalene manufacturing
industries.

In air Naphthalene is transformed to 1-Naphthaleneol, 2-Naphthalenetol and 2-

nitro-Naphthalenelene, which are lower to no toxic to humans.
Naphthalene is readily bio-degradable under aerobic conditions, hence even if
Naphthalene is present in ppm level it will readily oxidizes and if still unreacted
Naphthalene is present and seen in PA, it will undergo oxidation on further reaction
of PA for producing DOP and other plasticizers.

Cigarette contains 13.2 micro gram of Naphthalene in it. On an average in India

6.5 trillion cigarette is sold i.e. 13.2* 6.5= 858 Kgs approx per day is released in
the environment in India alone. And India is globally 12% accouted for smoking.
Hence, every day we release approx. 7150 kgs of Naphthalene to environment.

PA and other plasticizers is not a source of Naphthalene

No mention of PA as a potential source of Naphthalene
From the following page it can be concluded, PA or Plasticizers made of PA are not a
source of release of Naphthalene in the environment.
The release of Naphthalenephthalene from the production of other sources,
nowhere PA is mentioned.
Acc. To ECB, the main sources of Naphthalenephthalene is from combustion
processes. Viz gasoline engines, Diesel engines, Slow cure asphalt, industrial
emissions.
Manufacturing of Naphthalene based PA is happening outside India and doesn't
impact us.
Naphthalene is suspected, not sure if it is carcinogenic to humans.
Naphthalene is not a potential endocrine disruptor as per Danish EPA, 2014.
The major risk of being exposed to Naphthalene is from the indoor air from
cigarette smoke.
The occupational exposure limit is (1.5 mg/m3) but the doses given to mice/ rats
were 50 mg/m3.
The general population is exposed to Naphthalene, majorly not through the
Naphthalene manufacturing products but from the cigarette smoke and the air
pollution because of burning of fossil fuels.
The Naphthalene is placed in the group of possible carcinogen; this is concluded
from the results of the experiment which were done on rats and 10 times higher
doses were given to make the conclusion.
No conclusion can be drawn regarding the irritant properties of Naphthalene from
studies in humans. Majorly all the studies have been performed on rats, mice,
rabbits and dogs. NO STUDY HAS BEEN DONE ON HUMANS. So, conclusive effects
haven’t been discovered.

If Naphthalene through any medium gets in human body, more than 88% of the
concentration will be out of the human body through urine within few hours. Also,
if ingested within hours the Naphthalene will undergo our metabolism and will be
excreted out of the body.

Is it true for all ways of manufacturing PA or just the PA produced from

Naphthalene?
The study done by IIT-M is not a credible source and the results can’t be trusted.
As, IIT-M is being paid for the job. The report has taken many non-conclusive
assumptions.
This study holds true, only if Naphthalene is present. Also, has it been tested? If
yes, the scientific report can’t be so vague.
IIT –Madras study is done without the proper basis. They have presumed that the
Naphthalene is already present in PA. The study is vague and the language used is
not conclusive enough and diplomatic which unable to justify any Naphthalene
related effects or what so ever.

The index shows the literature study is for the effects of Naphthalene but not a
single scientific paper shows/ is present on the quantification of Naphthalene in PA.
or other plasticizers.