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Description of key information

The LD50 oral value determined by the study is 15.8 g/kg. This value is far above the limit for a classification as acute toxic.

It can be concluded based on the study results that the acute dermal toxicity is > 16960 mg/kg bw and thus far above the limit for a classification according to GHS criteria.

Exposure of humans is unlikely due to the low vapour pressure of the substance. The oral and dermal routes are considered to be the most relevant exposure routes.

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
other: as described by Smyth et al., Amer. Ind. Hyg. Assoc. J. 23, 95-107
GLP compliance:
not specified
Test type:
acute toxic class method
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
age 4 - 5 weeks
weight 90 - 120 g
Route of administration:
other: gastric intubation
No. of animals per sex per dose:
5 per dose
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
15 794 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value determined by the study is 15.8 g/kg. This value is far above the limit for a classification as acute toxic.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 794 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically valid. Adopted according to OECD SIDS (public available peer reviewed source).
Qualifier:
according to guideline
Guideline:
other: According to 24-hour cuff method of Draize et al. 1944
Principles of method if other than guideline:
The LD50 was determined by a method closely akin to the one-day cuff method of Draize et al. (1944) using groups of 4 male albino New Zealand rabbits. The fur was removed by clipping and the dose was retained beneath an impervious plastic film (i.e. occlusive). The animals were immobilized/exposed for 24 hours. Afterwards, the film was removed and the animals were observed for 14 days.
GLP compliance:
no
Test type:
standard acute method
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Type of coverage:
occlusive
No. of animals per sex per dose:
4 per dose
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 mL/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 960 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
It can be concluded based on the study results that the acute dermal toxicity is > 16960 mg/kg bw and thus far above the limit for a classification according to GHS criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
16 960 mg/kg bw

Additional information

It can be concluded based on the study results that the acute dermal toxicity is > 16960 mg/kg bw and thus far above the limit for a classification according to GHS criteria.

Justification for classification or non-classification