Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(6-methylbenzothiazol-2-yl)aniline
EC Number:
202-150-4
EC Name:
4-(6-methylbenzothiazol-2-yl)aniline
Cas Number:
92-36-4
Molecular formula:
C14H12N2S
IUPAC Name:
4-(6-methyl-1,3-benzothiazol-2-yl)aniline

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Nottongham University, School of Agriculture
- Age at study initiation: 12-16 wks
- Weight at study initiation: 2.2-2.53 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): Rabbit Diet, A.W. Tindall Ltd. Holbeach, Lincolnshire
- Water (e.g. ad libitum): Tab water ad libitum
- Acclimation period: min. 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 1
- Humidity (%): 50 - 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: all
Score:
0
Reversibility:
no data

Any other information on results incl. tables

The test material produced no positive criteria for skin irritation or corrosion.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU