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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline Study, but non GLP and no purity of test item available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Acclimation period: at least 4 days
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-amino-4-chlorobenzoic acid
EC Number:
220-635-9
EC Name:
3-amino-4-chlorobenzoic acid
Cas Number:
2840-28-0
Molecular formula:
C7H6ClNO2
IUPAC Name:
3-amino-4-chlorobenzoic acid

Test animals

Species:
rat
Strain:
other: Tif: RAIf
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: mean: female: 174 g; male: 190 g
- Fasting period before study: overnight
- Housing: 5 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 55±10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
(PEG 400)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
Doses:
1000, 2000, 4000, 8000 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: Physical condition and rate of deaths were monitored throughout the whole observation period. Bodyweights were recorded immediately prior to dosing and at 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Mortality was seen in the highest dose
Mortality:
1 of 5 male animals died after 24 hours at the highest dose. 1 of 5 female rat died after 24 hours at 2000 mg/kg bw group.
Clinical signs:
other: 1000, 2000, 4000 mg/kg bw: Slight sedation was seen the first 2 days. Slight dyspnoea was seen for 7 days. Slight exophtalmus was found from day 2 to 6 after treatment. The animals showed ruffeld fur until day 7 and slight curved position until day 5 afte
Gross pathology:
no abnormalities detected

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU