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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no detailed reporting of body weight, no purity for test material
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-aminophenol
EC Number:
202-431-1
EC Name:
2-aminophenol
Cas Number:
95-55-6
Molecular formula:
C6H7NO
IUPAC Name:
2-aminophenol
Test material form:
solid
Specific details on test material used for the study:
Supplier Hans Schwarzkopf GmbH

Test animals

Species:
rat
Strain:
other: CFY
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Anglia Laboratory Animals, Huntington, England
- Weight at study initiation: males 100 - 155g; females 90 - 115 g
- Fasting period before study: 16h
- Housing: 5 animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-1
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40%


Doses:
1000, 1600, 2500, 4000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 500 mg/kg bw
Based on:
test mat.
Mortality:
1000 mg/kg bw: one male
1600 mg/kg bw: one male and one female
2500 mg/kg bw: three males and one female
5000 mg/kg bw: four males and five females
Clinical signs:
other: All dose groups showed curved body position, piloerection, increased breathing rate. There was dose-dependent ataxia and lethargy, paleness of extremities, tremor. Urine was coloured orange-red.
Gross pathology:
Hyperemia of liver and lung, partly also of duodenum

Applicant's summary and conclusion