Registration Dossier
Registration Dossier
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EC number: 224-658-5 | CAS number: 4439-24-1
Endpoint summary
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
- 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Two oral LD50 values for rat from seperate unpublished studies were reported in a scientific handbook.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.
Referenceopen allclose all
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
- 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.
Reference
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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