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EC number: 939-707-2
CAS number: -
The available experimental data in animals displayed limited evidences of absorption and systemic distribution of the test substance and/or its metabolites or degradation products through the inhalation, oral and dermal route. Despite the absence of systemic effects reported in the acute and repeated dose toxicity studies by the oral and inhalation routes, absorption through these routes of exposure is demonstrated by the mortality reported in the rats and/or mice acute toxicity studies (only local changes in the lung indicative of local effects were reported in the inhalation studies). Very limited distribution is expected since there was no evidence of systemic effect reported whatever the route of administration. Systemic effects observed when the test substance was dermally applied in the acute dermal toxicity study were limited and reported only at very high dose level. There was no obvious indication on the test substance metabolism or excretion from the toxicity studies.
toxicokinetic studies are available on Reaction product of naphthalene,
butanol, sulfonated and neutralized by caustic soda. A toxicokinetic
assessment was made, based on the physico-chemical properties of the
test substance or its close analogue “Reaction product of naphthalene,
propan-2-ol, sulfonated and neutralized by caustic soda” and the results
of toxicity studies (acute oral, inhalation and dermal toxicity,in
studies and repeat dose toxicity studies).
weight: approx. 300 g/mol (UVCB)
solubility: 604 g/L (at 20°C)
coefficient in octanol/water: -0.27 (at 20°C)
size: D10: >125 - <180 µm ; D50: >710 - < 1000 µm ; D95: > 1mm.
pressure: < 0.001
point: >500 °C
1.525 (at 20°C)
and distribution :
acute inhalation toxicity study, mortality was observed in rats exposed
for 4 hours to aerosol of Reaction product of naphthalene, butanol,
sulfonated and neutralized by caustic soda. Indeed, premature death was
recorded in 1/10 and 9/10 rats at dose levels of 3.49 and 4.76 mg/L,
respectively within 14 days post-exposure. Clinical signs such as
accelerated respiration, eyelid closure, irregular and intermittent
respiration, reddish discharge from nose, reduced general state and/or
piloerection were reported at the mid and high dose. At necropsy dead
animals from high dose group showed general congestive hyperemia and a
lung filled with blood and edema. The animal which died from the mid
dose group showed excessive loss of weight, empty stomach/intestines,
filled with gas. Whereas the systemic toxicity is evidenced by the
mortality reported at the 2 highest dose levels, this study do not
permit to make considerations on the distribution of the registered
substance and/or its metabolites or degradation products. Some clinical
signs (effects on respiration and nose) and the macroscopic findings in
the lung are rather indicative of a local effect. These results are
consistent with the results obtained in the 28-day repeated dose
inhalation toxicity study in rat where only local effects in the lung
were reported from the mid dose of 8.1 mg/m3.
The capacity of the substance to be absorbed through the respiratory
tract is nevertheless supported by the significant proportion of
inhalable particles (<100 µm) and the high water solubility of the
acute oral toxicity studies, mortality was observed in rats and mice
exposed to one single oral (gavage) administration of Reaction product
of naphthalene, butanol, sulfonated and neutralized by caustic soda from
the dose of 1600 and 2500 mg/kg bw, respectively. Clinical signs such as
deterioration of general health and labored breathing were reported at
almost all concentrations. Mortality and clinical signs are indicative
of absorption of the registered substance and/or its metabolites. The
systemic distribution could not be evaluated in the absence of target
organs identified in the available studies. In the 5-week oral (drinking
water) rat toxicity study, no evidence of absorption and systemic
distribution were identified.
acute dermal toxicity study performed in rabbits, Reaction product of
naphthalene, butanol, sulfonated and neutralized by caustic soda applied
on the skin induced mortality in animals treated with 4000 mg/kg bw.
There were no signs of skin irritation at any dose levels. Petechiae on
the mucous membranes of the stomach seen at necropsy in 3/4 rabbits
given 4000 mg/kg suggest a limited absorption and systemic distribution
of the registered substance only at very high dose levels.
vitro studies assessed the potential genotoxicity of Reaction
product of naphthalene, butanol, sulfonated and neutralized by caustic
soda or its analogue Reaction product of naphthalene, propan-2-ol,
sulfonated and neutralized by caustic soda. Three Ames tests (BASF,
1992, Herbold 1983, and CitoxLab 2012), a chromosome aberration test in
cultured human lymphocytes (CitoxLab 2012) and a mouse lymphoma assay
(CitoxLab 2012); all showed absence of mutagenic effects in the presence
or in the absence of exogenous mammalian metabolic activation system. In
the second experiment of the Ames test performed on the analogue
Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized
by caustic soda, moderate to strong cytotoxicity was observed in all
tested strains at the highest concentration only (5000 µg/plate) in the
presence of metabolic activation (pre-incubation method). No
cytotoxicity was observed without metabolic activation. Therefore the
toxicity reported in the presence of S9 mix suggests that the analogue
Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized
by caustic soda is metabolized and the synthesized metabolite(s) is(are)
toxic to bacterial strain at this dose level. However, in the absence of
specific metabolism studies and since this variation was not seen in the
Ames tests conducted with the registered substance, the relevance of
this variation to human is unclear. In the Mammalian mouse lymphoma
assay and chromosome aberration test conducted on the analogue,
cytotoxicity was observed both in the presence and absence of metabolic
activation, at similar dose levels. Therefore no conclusion on the
metabolism can be drawn from these two tests.
There is no
indication of a preferred route of excretion for Reaction product of
naphthalene, butanol, sulfonated and neutralized by caustic soda but its
high water solubility indicate that excretion of unchanged parent
substance and/or metabolites could occur by renal or biliary routes and
that bioaccumulation is unlikely.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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