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Administrative data

Description of key information

Oral LD50 is >5000 mg/kg bw

Dermal LD50 is >5000 mg/kg bw

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 with acceptable restrictions
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals used
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Examinations performed: mortality and toxicity
Key result
Sex:
not specified
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
Diarrhea was observed on day 1 and 2. Lethargy was observed on day 4.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
5 000 mg/kg bw
Quality of whole database:
One Klimisch 2 study available. Performed similar to guideline.

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:
comparable to guideline study with acceptable restrictions
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
not specified
Doses:
5000 mg/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Examinations performed: mortality, toxicity and skin irritation
Key result
Sex:
not specified
Dose descriptor:
discriminating dose
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal died on day 3
Clinical signs:
No toxicity observed
Other findings:
Skin irritation: Slight redness 2/10; Moderate redness 8/10; Slight edema 4/10; Moderate edema 6/10
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
5 000 mg/kg bw
Quality of whole database:
One Klimisch 2 study available. Performed similar to guideline.

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed similar to OECD 401, the test substance was administered via the oral route to ten rats. The concentration administered was 5000 mg/kg bw and the animals were observed for 14 days. No mortality was observed. Diarrhea was observed on day 1 and 2 and lethargy was observed on day 4. The LD50 was determined to be >5000 mg/kg bw.

Acute dermal toxicity:

In an acute dermal toxicity study performed similar to OECD 402, the test substance was administered dermally to ten rabbits. The concentration applied was 5000 mg/kg bw and the animals were observed for 14 days. One animal died on day 3. No toxic effects were observed. The LD50 was determined to be >5000 mg/kg bw.

Justification for classification or non-classification

The test substance does not have to be classified for acute oral or dermal toxicity according to Regulation (EC) No 1272/2008.