Registration Dossier

Administrative data

Description of key information

An acute toxicity study via the oral route was not carried out as the substance is classified as corrosive. However, oral LD50 values for rat ranging from 400 mg/kg bw to 1000 mg/kg bw were reported in a handbook. Based on these values the subtance should be classified as acute toxicity Category 4 in accordance with Regulation (EC) No 1272/2008.

There was no available data on the acute toxicity of the substance via the inhalation route.

For acute toxicity via the dermal route, values of dermal LD50 of 200 -400 mg/kg bw for rabbit was reported in a toxicology handbook. Based on the reported values the substance meets the criteria for Acute toxicity Category 3 via the dermal route in accordance with CLP regulation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
Data from handbook: no guideline or method reported.
GLP compliance:
not specified
Test type:
other: Not specified
Species:
rat
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
400 mg/kg bw
Based on:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 000 mg/kg bw
Based on:
not specified
Other findings:
Hemolysis as evidenced by hemoglobinuria and associated liver and kidney injury
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
LD50 values for rats of 400 mg/kg and 1000 mg/kg bw were reported in a toxicology handbook. Both values fall within the classification criteria for Acute Toxicity Category 4 via the oral route in accordance with Regulation (EC) N° 1272/2008.
Executive summary:

Two oral LD50 values for rat from seperate unpublished studies were reported in a scientific handbook. No information on the method was given. The LD50 values of 400 mg/kg bw and 1000 mg/kg bw both fall within the classification criteria for Acute Toxicity Category 4 via the oral route in accordance with Regulation (EC) N° 1272/2008.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
400 mg/kg bw

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:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
Data from handbook; no guideline or method described.
GLP compliance:
not specified
Test type:
other: Not specified
Species:
rabbit
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
>= 200 - <= 400 mg/kg bw
Based on:
not specified
Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
Based on an dermal LD50 range of 200-400 mg/kg bw for rabbit, the substance meets the criteria for classification as Acute toxicity Category 3 via dermal route in accordance with Regulation (EC) N° 1272/2008.
Executive summary:

A dermal LD50 of 200 -400 mg/kg bw for rabbit was reported in a toxicology handbook. No inforamtion on the test method was given. Based on the reported values the substance meets the criteria for Acute toxicity Category 3 via the dermal route in accordance with Regulation (EC) N° 1272/2008.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
200 mg/kg bw

Additional information

Justification for classification or non-classification

An acute oral LD 50 of 400 mg/kg in rats was reported in a toxicology handbook. According to CLP Regulation an Acute LD 50 value between 300 and 2000 mg/kg meets the criteria for classification as Acute Toxicity Category 4 via the Oral route.

An acute dermal LD 50 of 200-400 mg/l was reported in a toxicology handbook. According to CLP Regulation an Acute LD 50 value between 200 and 1000 mg/kg meets the criteria for classification as Acute Toxicity Category 3 via the dermal route.