Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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.