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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
1, 2, 4, 8, 16, 24, 30 g/kg bw
No. of animals per sex per dose:
5
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 30 000 mg/kg bw
Based on:
test mat.
Gross pathology:
No remarkable effects observed.
Interpretation of results:
GHS criteria not met
Conclusions:
No signs of gross toxicity and patholgy at dose of 30 g/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
30 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Acute oral toxicity to rat was conducted for the target substance and the LD50 was found to be greater than 30 g/kg bw. Mortality was observed at lower dose but was regarded as not dose-related.

The hydrolysis product isostearic acid has LD50 (rat) greater than 32ml/kg (appox. 28.8 g/kg) (CIR, 1983) and is therefore non-toxic.

TiO2 was considered non-hazardous, based on the published data on EHCA C&L database. The lowest dose reported to produce any toxic effect in rats by oral route is determined to be 60 g/kg (US EPA, 1994).

Based on above findings, the target substance is considered not acute toxic and there is no need to classify the substance as acute oral toxic.