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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
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:
other: 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
Value:
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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
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:
other: 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
Value:
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.