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Toxicological information

Acute Toxicity: oral

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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:
1977
Bibliographic source:
Food. Cosmet. Toxicol.15, 607 - 610.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male/female
Details on test animals 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