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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to Guideline, but non-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-chloro-o-toluidine
EC Number:
201-756-6
EC Name:
3-chloro-o-toluidine
Cas Number:
87-60-5
Molecular formula:
C7H8ClN
IUPAC Name:
3-chloro-2-methylaniline
Details on test material:
- Test substance number: 85/48
- name of test substance: 3-chlor-2-methylanilin

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler: D-6065 Offenbach/Main, FRG
- Mean weight at study initiation: 2.57 kg (male), 2.55 kg (females).
- Housing: single
- Diet: Kliba 341, 4 MM; Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland; approx. 130 g/animal/day
- Water: approx. 250 mL tap water per animal per day
- Acclimation period: at least 8 days before testing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping of the fur
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL of the unchanged test substance
Duration of treatment / exposure:
4 h
Observation period:
72 h
reading time point: 30 to 60 minutes, 24 h, 48 h and 72 hours after application
Number of animals:
3 (1 male; 2 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 1 - 0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 2 - 1 - 0
Irritation parameter:
edema score
Basis:
animal: #1 and 2
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 0 - 0
Other effects:
Scaling was found in animal #1 after 48 and 72 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Based on the results of this study, the test substance 3-chloro-o-toluidine does not need to be classified as dermal irritant, according to EEC/67/548 and Regulation (EC) No. 1272/2008.