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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key study: EU Method B.1 (GLP study). The oral LD50 in rats was determined to be higher than 2000 mg/kg bw.


Key study: EU Method B.3 (GLP study). The dermal LD50 in rats was determined to be higher than 2000 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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Remarks:
Crl:(WI) BR
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
other: No vehicle was used. The test substance was dosed undiluted.
Doses:
2000 mg/kg bw
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
salivation
Body weight:
other body weight observations
Remarks:
The body weight gain of the animals over the study period was considered to be similar to that expected of normal animals of the same age and strain.
Gross pathology:
Macroscopic post mortem examination of the animals at termination did not reveal any abnormalities.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 in rats was higher 2000 mg/kg bw.
Executive summary:

The study was conducted according to EU Method B.1 and OECD 401 (GLP study). Albino wistar male and female rats were exposed orally to 2000 mg/kg bw test substance (limit test). Not significant clinical signs neither organ effects were observed. Thus, the oral LD50 was determined to be higher than 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
The study is a GLP compliant and has a Klimisch score 1.

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
Wistar
Remarks:
Crl:(WI) BR
Sex:
male/female
Type of coverage:
semiocclusive
Vehicle:
other: No vehicle was used. The test substance was dosed undiluted.
Duration of exposure:
24 h
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other:
Body weight:
other body weight observations
Remarks:
The animals showed expected body weight gain during the study
Gross pathology:
No abnormalities were found at macroscopic post mortem examination
Other findings:
Signs of toxicity (local):
Erythema, scales and scabs in the treated skin-area and red staining in the neck were seen among several animals during the observation period.
The animals had recovered from the symptoms between days 5 and 8, except for red staining in the neck of one female which persisted until termination of the study.
Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 in rats was determined to be higher than 2000 mg/kg bw.
Executive summary:

The study was conducted according to EU Method B.3 (GLP study). Wistar Crl:(WI) BR male and female rats were treated with the substance at 2000 mg/kg bw (limit test). Due to the absence of mortality, relevant clinical signs and abnormalities in the organs, the dermal LD50 was determined to be higher than 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 2 000 mg/kg bw
Quality of whole database:
The study is GLP compliant nad has a Klimisch score 1.

Additional information

Justification for classification or non-classification

Based on the available data (LD50 > 2000 mg/kg bw), the substance does not need to be classified for acute toxicity according to the CLP Regulation (EC) no. 1272/2008.