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EC number: 700-597-4
CAS number: 1215841-86-3
In acute oral and acute inhalation toxicity tests and in all other tests
at present the substance showed no effects leading to classification and
labelling. In particular the substance has no skin irritating, no skin
sensitizing and no eye irritation properties that would lead to
classification and labelling. According to "Guidance on information
requirements and chemical safety assessment Chapter R.8:
Characterisation of dose [concentration]-response for human health"
APPENDIX R. 8-8 "...a DNEL for acute toxicity should be derived if an
acute toxicity hazard (leading to C&L) has been identified and there is
a potential for high peak exposures". Based on present information the
substance showed no effects leading to classification and labelling and
hence the derivation of acute DNEL is not appropriate.
A 14 day inhalation study is available. No relevant effects were
observed and the NOEC is greater than 1.03 mg/L which represents the
highest concentration that was technically feasible in the study.
A 90 day oral repeated dose toxicity study was performed in rats
according to OECD 408. Daily oral (gavage) administration of the test
item to Wistar rats for 90 consecutive days at 100, 300 and 1000 mg/kg
bw/day was associated with minor effects at the highest dose level only.
High dose group findings included slight anaemia with lower RBC and HGB
concentrations (females only), increased Albumin and consequently
increased Total Protein concentrations, and increased A/G ratio in both
sexes with association to statistically significant increased liver
weight values (including the brain and body weight relative values) in
females and statistically significant increased body weight relative
values in males. Statistically significant increased kidney weight
values (including the brain and body weight relative values) in females
and statistically significant increased body weight relative values in
males were observed after 90 days exposure without relevant
histopathological changes. Although signs of reversibility were observed
in recovery animals, the changes in female liver (brain weight relative
value only), kidneys and haematology parameters persisted to some
extent. No effects of toxicological relevance were observed at the low
or mid dose levels.
In conclusion, the NOAEL of the test item administered by oral
gavage to Wistar rats for 90 consecutive days is considered to be 300
mg/kg bw/day based on a precautionary worst case approach.
is not used directly in consumer products. Hence, DNEL´s are not derived
for general population.
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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