Registration Dossier
Registration Dossier
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EC number: 204-616-2 | CAS number: 123-30-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedures based on scientific principles and standards, limited documentation, acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Assessment of the acute toxicity and potential irritancy of hair dye constituents.
- Author:
- Lloyd, G. K., Liggett, M. P., Kynoch, S. R., and Davies, R. E.
- Year:
- 1 977
- Bibliographic source:
- Food. Cosmet. Toxicol.15, 607 - 610.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-aminophenol
- EC Number:
- 204-616-2
- EC Name:
- 4-aminophenol
- Cas Number:
- 123-30-8
- Molecular formula:
- C6H7NO
- IUPAC Name:
- 4-aminophenol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 90 - 122 g
- Fasting period before study: overnight
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous gum tragacanth
- Doses:
- In a preliminary range finding study, the freshly prepared solutions or suspensions were administered to groups of two male and two female rats by oral intubation in a range of dosage volumes, in order to find the approximate median lethal oral dose (LD50). After these preliminary range-finding tests had given a rough approximation of the LD50, larger groups of rats (five males and five females) were used in order to locate the median lethal dose more precisely. A logarithmic dosage interval of 1.6 was used.
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 671 mg/kg bw
- 95% CL:
- >= 550 - <= 818
Any other information on results incl. tables
CFY strain rats (5 males and 5 females) were given 4-aminophenol orally as a 0.5% aqueous tragacanth formulation. The LD50 was 671 (550 to 818) mg/kg body weight.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
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