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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The acute dermal LD50 for rabbits was greater than 5000 mg/kg bw.
The test substance had an acute oral LD50 greater than 5000 mg/kg bw in rats.

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:
No data provided
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)
Deviations:
not specified
Principles of method if other than guideline:
The test substance was orally applied to rats. Mortality was screened for 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data provided.
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data provided.
Doses:
5000 mg/kg
No. of animals per sex per dose:
10 animals (no sex distribution stated)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs
Statistics:
No data provided.
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1 animal died 4 days after treatment.
Clinical signs:
other: Rats were slightly lethargic.
Gross pathology:
No data provided.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance had a acute oral LD50 of greater than 5000 mg/kg bw in rats.
Executive summary:

A test for acute oral toxicity was done in rats. The animals were observed for 14 days after treatment. One rat died after 4 days and all animals showed slight lethargy. The acute oral LD50 for rats was established to be greater than 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
The available study is sufficient for assessment.

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:
supporting study
Study period:
No data provided
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)
Deviations:
not specified
Principles of method if other than guideline:
Dermal treatment with the test substance on rabbits was performed.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data provided.
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data provided.
Duration of exposure:
No data provided
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals (no sex distribution stated)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
- Other examinations performed: clinical signs
Statistics:
No data provided.
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
other: 1 Rabbit showed diarrhea on day 1 after treatment. Skin irritations: - Moderate redness: 10/10 - Slight edema: 5/10 - Moderate edema: 5/10
Gross pathology:
No data provided.
Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 for rabbits was greater than 5000 mg/kg bw.
Executive summary:

An acute dermal toxicity study was conducted. 10 rabbits were treated with the test substance. On day 1 after treatment one animal had diarrhea. Moderate redness was observed in 10/10 animals. Slight and moderate edema were each seen in 5/10 rabbits. The acute dermal LD50 for rabbits was concluded to be greater than 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
The available study is sufficient for assessment.

Additional information

Acute oral:

A test for acute oral toxicity was done in rats. The animals were observed for 14 days after treatment. One rat died after 4 days and all animals showed slight lethargy. The acute oral LD50 for rats was established as being greater than 5000 mg/kg bw.

Acute dermal:

An acute dermal toxicity study was conducted. 10 rabbits were treated with the test substance. On day 1 after treatment one animal had diarrhea. Moderate redness of the skin was observed in 10/10 animals. Slight and moderate edema were each seen in 5/10 rabbits. The acute dermal LD50 for rabbits was concluded to be greater than 5000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on acute toxicity via oral and dermal route, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the ninth time in Regulation (EU) No 2016/1179.