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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
In an acute dermal toxicity study the LD50 was determined to be >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)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Sex:
not specified
Doses:
1480, 2200, 3330 and 5000 mg/kg bw
No. of animals per sex per dose:
10 (total number of animals per dose, sex not specified)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
3 300 mg/kg bw
Based on:
test mat.
Mortality:
Dose 2220 mg/kg bw = 2 animals
Dose 3330 mg/kg bw= 4 animals
Dose 5000 mg/kg bw= 10 animals
Clinical signs:
5000 mg/kg bw = Lethargy
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute oral toxicity study the LD50 was determined to be 3300 mg/kg bw.
Executive summary:

In a study of Moreno, 1973, the acute oral toxicity of the test item was determined. The study was conducted with 10 rats per group. The test item was administered in doses of 1480, 2220, 3330 and 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. Mortality was observed in doses from 2200 mg/kg bw onwards. The LD50 was determined to be 3300 mg/kg bw. Lethargy was observed in animals of the highest dose group.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
3 300 mg/kg bw
Quality of whole database:
Only basic data given, no GLP study, acceptable, well documented publication, 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)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Sex:
not specified
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 animals (total numer of animals, sex not specified
Details on study design:
- Duration of observation period following administration: 14 days
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
1/10
Clinical signs:
In 5/10 animals anorexia on days 1, 2
1/10 animals extreme weakness prior to death
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity study the LD50 was determined to be >5000 mg/kg bw.
Executive summary:

The acute dermal toxicity of the test item was determined. The study was conducted with 10 rabbits. They received a dermal application of 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. One of 10 animals died during the study. The calculated LD50 was determined to be >5000 mg/kg bw. Toxic effects were found in 5/10 animals on days 1 and 2. They showed signs of anorexia. An extreme weakness was found in 1 animal prior to death.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
Basic data given, acceptable, well documented publication, no GLP study, similar to guideline

Additional information

Acute oral toxicity

Key study

Acute toxicity study on rats and rabbits (Moreno, 1973)

The acute oral toxicity of the test item was determined. The study was conducted with 10 rats per group. The test item was administered in doses of 1480, 2220, 3330 and 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. Mortality was observed in doses from 2200 mg/kg bw onwards. The LD50 was determined to be 3300 mg/kg bw. Lethargy was observed in animals of the highest dose group.

Acute dermal toxicity

Key study

Acute toxicity study on rats and rabbits (Moreno 1973)

The acute dermal toxicity of the test item was determined. The study was conducted with 10 rabbits. They received a dermal application of 5000 mg/kg bw. The animals were observed for mortality and/or systemic effects for 14 days. One of 10 animals died during the study. The calculated LD50 was determined to be >5000 mg/kg bw. Toxic effects were found in 5/10 animals on days 1 and 2. They showed signs of anorexia. An extreme weakness was found in 1 animal prior to death.


Justification for selection of acute toxicity – oral endpoint
Only basic data given, no GLP study, acceptable, well documented publication, similar to guideline

Justification for selection of acute toxicity – dermal endpoint
Basic data given, acceptable, well documented publication, no GLP study, similar to guideline

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 (EC) 1272/2008 (CLP). As a result the substance is not considered to be classified for acute oral toxicity, for acute inhalation toxicity and for acute dermal toxicity under Regulation (EC) No 1272/2008.