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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
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study.
Qualifier:
no guideline available
Principles of method if other than guideline:
No guideline available in the report as the test has been performed prior to the OECD guideline. Howvere it conforms to the OECD 401 guideline.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
propylene glycol
Remarks:
Concentration in vehicle: 50 %
Doses:
4,8 ; 5,8 ; 6,9 ; 8,3 and 10 mL/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4.02 mL/kg bw
Based on:
test mat.
95% CL:
3.34 - 4.85
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: GHS EU
Conclusions:
The LD50 of the test substance to male/female Wistar rats was found to be 4.02 ml/kg bw.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
4.02 mg/kg bw
Quality of whole database:
Two studies are available to address the acute oral toxicity endpoint. Both were conducted in a method similar to OECD 401 and both pre-date GLP. The key study investigated a range of test material concentrations and it was possible to deduce a substance classfication from the study findings; it was therefore assigned a reliability score of 2 in accordance with Klimisch (1997). The supporting study was conducted as a limit test; it was not possible to determine a substance classification from the study findings and hence it was assigned a reliability score of 4 and regarded a range finder for the key study. Overall the quality of the database if high.

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

Key

TNO 1981a was chosen as the key study over 1981b, on the basis that it gives a definitive LD50, which can be used for classification and labelling purposes.

The acute oral toxicity of the test substance was examined in a gavage study using male/female Wistar rats. The study was performed in a method similar to OECD guideline 401. The study pre-dates GLP. The study was assigned a reliability score of 2, in accordance with the scoring system of Klimisch et al (1997).

At 3.45 mL/kg bw, 3/10 animals were found dead (1 male and 2 females).

At 4.15 ml/kg bw, 6/10 animals were found dead (2 males and 4 females).

At 5 ml/kg bw, 8/10 animals were found dead (4 males and 3 females).

Therefore the LD50 of the test substance for males/females Wistar rats was estimated to be 4.02 mL/kg bw.

Supporting

The acute oral toxicity of the test substance was examined in a gavage limit-test study using male/female Wistar rats. The study was performed in a method similar to OECD guideline 401. The study pre-dates GLP.

During the study the rats were all given a single dose of 5 mL/kg bw

7/10 male rats and 7/10 female rats died during the 14 day observation period. The LD50 of the test substance to male/female Wistar rats was therefore < 5 mL/kg bw


Justification for selection of acute toxicity – oral endpoint
The key study was selected as it is the only available study enabling substance classification.

Justification for classification or non-classification

With respect to the acute oral toxicity data that are available for the test substance, no classification is required for acute oral toxicity, in accordance with Regulation (EC) No. 1272/2008.