Registration Dossier

Administrative data

Description of key information

Oral LD50: 500 mg/kg bw < LD50 < 1000 mg/kg bw (publication 1964/ ECHA dossier 2014) 
Inhalation LC50: LC50=10 mg/L (publication 1964/ ECHA dossier 2014)

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: A secondary literature only
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Remarks:
due to the minimum information given
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
water
Doses:
Not indicated precisely. Only from the results one can assume that at least the following concentrations were used: 250 mg/kg bw and 1000 mg/kg bw
No. of animals per sex per dose:
90 rats in the study. Number of animals per sex per dose not indicated.
Control animals:
no
Sex:
not specified
Dose descriptor:
LD100
Effect level:
1 000 mg/kg bw
Based on:
test mat.
Sex:
not specified
Dose descriptor:
LD0
Effect level:
250 mg/kg bw
Based on:
test mat.
Sex:
not specified
Dose descriptor:
other: LD10
Effect level:
500 mg/kg bw
Based on:
test mat.

In the clinical picture, breathing disturbances similar to those that occur in acute inhalation poisoning are observed. In individual animals the motor activity is intensified immediately after administration of the substance, although the animals display less movement and motor activity more often. Varying degrees of haemorrhaging and necrosis in the mucous membranes of the stomach, dystrophic changes in the liver, kidneys and brain were detected in macro-and micro-investigations of organ of dead rats.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
500 mg/kg bw
Quality of whole database:
Sufficient for classification and labelling determination.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature with minimal information on study design and results.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
Remarks:
due to the minimum information given
GLP compliance:
no
Test type:
other: not specified, probably standard acute method
Limit test:
no
Species:
other: rats and mice
Strain:
not specified
Sex:
not specified
Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
not specified
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
2 h
Concentrations:
Not indicated
No. of animals per sex per dose:
120 rats and 110 mice
Control animals:
no
Sex:
not specified
Dose descriptor:
LC50
Effect level:
13.5 mg/L air
Based on:
test mat.
Exp. duration:
2 h
Remarks on result:
other: determined in mice
Sex:
not specified
Dose descriptor:
LC50
Effect level:
10 mg/L air
Based on:
test mat.
Exp. duration:
2 h
Remarks on result:
other: determined in rats
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
10 000 mg/m³
Quality of whole database:
Poor, worst-case classification and labelling was determined.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

In an acute oral toxicity study in rats, LD0, LD10 and LD100 values of 250, 500 and 1000 mg/kg bw were obtained, respectively. Thus, based on these results a LD50 value between 500 and 1000 mg/kg bw was determined (500 mg/kg bw < LD50 < 1000 mg/kg bw).

Acute inhalation toxicity

Rats and mice were exposed for 2 hours to vapors of the test substance. LC50 values of 13.5 mg/L and 10 mg/L were obtained, respectively. Although limited data were available, the lower study result was considered for C & L determination as worst-case for safety reasons.

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. As a result the substance is considered to be classified as Acute Tox. 4; H302 and Acute Tox. 4 H332 under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation EC 2017/776.