Registration Dossier
Registration Dossier
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EC number: 240-357-1 | CAS number: 16245-77-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from Publication.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Acute dermal toxicity study of test chemical was performed in rodents.
- Author:
- CARPENTER et. al.
- Year:
- 1 974
- Bibliographic source:
- Toxicology and Applied Pharmacology
- Reference Type:
- other: authoritative database
- Title:
- Acute Dermal Toxicity in rodents
- Author:
- IFA GESTIS
- Year:
- 2 018
- Bibliographic source:
- IFA GESTIS, GESTIS SUBSTANCE Database, 2018.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as metioned below
- Principles of method if other than guideline:
- Acute dermal toxicity study of test chemical in rabbit.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
Test material
- Reference substance name:
- Dapsone
- EC Number:
- 201-248-4
- EC Name:
- Dapsone
- Cas Number:
- 80-08-0
- Molecular formula:
- C12H12N2O2S
- IUPAC Name:
- 4,4'-Diaminodiphenyl Sulphone
- Details on test material:
- Name: 4,4'-Diamino diphenyl sulfone InChI: 1S/C12H12N2O2S/c13-9-1-5-11(6-2-9)17(15,16)12-7-3-10(14)4-8-12/h1-8H,13-14H2Smiles : S(c1ccc(N)cc1)(c1ccc(N)cc1)(=O)=O- Molecular formula (if other than submission substance):C12H12N2O2S- Molecular weight (if other than submission substance):248.305 g/mole- Substance type:organic- Physical state:solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Type of coverage:
- other: Dermal
- Vehicle:
- not specified
- Details on dermal exposure:
- not specified
- Duration of exposure:
- not specified
- Doses:
- 4000 mg/kg
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No Mortality observed
- Mortality:
- No Mortality observed at 4000 mg/kg
- Clinical signs:
- not specified
- Body weight:
- not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 was considered to be >4000 mg/kg bw, when rabbits were treated with test chemical by dermal application to the skin.
- Executive summary:
Acute Dermal toxicity study was conducted in rabbits using test chemical at the concentration of 4000 mg/kg bw. No Mortality observed at 4000 mg/kg. Therefore, LD50 was considered to be >4000 mg/kg bw, when rabbits were treated with test chemical by dermal application to the skin.
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