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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
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
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
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
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
671 mg/kg bw
95% CL:
>= 550 - <= 818

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.

Interpretation of results:
Category 4 based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
671 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
3.42 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
8 000 mg/kg bw

Additional information

Justification for classification or non-classification

Based on the CLP criteria, 4-aminophenol is classified as a Category 4 for acute oral toxicity, not classified for dermal toxicity and a Category 4 for acute inhalation toxicity based on the available data.