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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation is insufficient for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
; different volumes applied, reporting deficiencies concerning housing, body weights, signs of toxicity
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-chloroaniline
EC Number:
202-426-4
EC Name:
2-chloroaniline
Cas Number:
95-51-2
Molecular formula:
C6H6ClN
IUPAC Name:
2-chloroaniline
Details on test material:
IUCLID4 Test substance: no data
- Name of test material (as cited in study report): o-Chloranilin
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
other: Wistar-II
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann
- Weight at study initiation: 160-180 g
- Housing: 5 per cage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.6 mL/ kg

Doses:
0.5, 0.7, 0.9, 1.0, 1.6 ml/kg body weight
No. of animals per sex per dose:
10 male rats per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day of dosing every hour and once a day thereafter until day 7 post application and then again on day 14
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
The LD50 was calculated by the method of Fink and Hund (1965)

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 016 mg/kg bw
95% CL:
883 - 1 186
Remarks on result:
other: density 1.21 mg/ cm³; no constant volumes applied
Mortality:
0.5 mL (605 mg)/ kg /bw: 0/10
0.7 mL (847 mg)/ kg /bw: 4/10; 3h-2d post-application
0.9 mL (1089 mg)/ kg /bw: 6/10; 2d post-application
1.0 mL (1210 mg)/ kg /bw: 6/10; 3h-2d post-application
1.6 mL (1936 mg)/ kg /bw: 6/10; 1h-2d post-application
Clinical signs:
other: 0.5 mL (605 mg)/ kg /bw: sedation, convulsion, chromodakryorrhoe 0.7 mL (847 mg)/ kg /bw: sedation, convulsion 0.9 mL (1089 mg)/ kg /bw: sedation, convulsion, chromodakryorrhoe 1.0 mL (1210 mg)/ kg /bw: sedation, convulsion, face down position 1.6 mL (193
Gross pathology:
no data

Applicant's summary and conclusion