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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In an acute oral toxicity study the LD50 was determined to be 3300 mg/kg bw.

The LD50 value for acute dermal toxicity was determined to be greater than 5000 mg/kg bw in rabbits.

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:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data
Route of administration:
oral: unspecified
Doses:
2050, 2560, 3200, 4000 and 5000 mg/kg bw
No. of animals per sex per dose:
10
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 300 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 030 - <= 3 570
Mortality:
2050 mg/kg bw: none
2560 mg/kg bw: 4/10
3200 mg/kg bw: 5/10
4000 mg/kg bw: 9/10
5000 mg/kg bw: 9/10
Clinical signs:
other: 2050 mg/kg bw: none all higher doses: lethargy, pilorection, tremors, chromodacryorrhea
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study the LD50 was determined to be 3300 mg/kg bw in rats.
Executive summary:

The acute oral toxicity of the test item was determined in rats. The study was conducted with 10 rats per group. The test item was administered in doses of 2050, 2560, 3200, 4000 and 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. Mortality was observed in doses from 2560 mg/kg bw onwards. Lethargy, pilorection, tremors, chromodacryorrhea were observed at doses from 2560 mg/kg bw onwards. The LD50 was determined to be 3300 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
3 300 mg/kg bw
Quality of whole database:
Similar to Guideline with sufficient details for assessment.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

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
Details on test animals or test system and environmental conditions:
no data
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: none
Other findings:
Skin irritation: moderate redness in 1 of 5 animals
Interpretation of results:
GHS criteria not met
Conclusions:
A LD50 value greater than 5000 mg/kg bw was determined in a dermal toxicity in rabbits after treatment with the test item.
Executive summary:

To assess the acute dermal toxicity potential of the test item, a study equivalent to OECD TG 402 was performed. Five rabbits were each incubated with the limit dose of 5000 mg/kg bw. No clinical signs and no mortality was observed. Moderate redness was observed in one animal.

Based on the results of this study, the LD50 value for acute dermal toxicity was determined 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:
Similar to Guideline with sufficient details for assessment.

Additional information

Acute oral toxicity

The acute oral toxicity of the test item was determined in rats. The study was conducted with 10 rats per group. The test item was administered in doses of 2050, 2560, 3200, 4000 and 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. Mortality was observed in doses from 2560 mg/kg bw onwards. Lethargy, pilorection, tremors, chromodacryorrhea were observed at doses from 2560 mg/kg bw onwards. The LD50 was determined to be 3300 mg/kg bw.

Acute dermal toxicity

To assess the acute dermal toxicity potential of the test item, a study equivalent to OECD TG 402 was performed. Five rabbits were each incubated with the limit dose of 5000 mg/kg bw. No clinical signs and no mortality was observed. Moderate redness was observed in one animal.

Based on the results of this study, the LD50 value for acute dermal toxicity was determined 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 are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No 1272/2008,

as amended for the tenth time in Regulation (EC) No 2017/776.