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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.