Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
: lack of details on test substance
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzothiazol
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill ltd., Huntingdon, UK
- Age at study initiation: no data
- Weight at study initiation: 3 - 4 kg
- Housing: single per cage
- Diet: ad libitum(Saniff K 4, Versuchtierdiaeten GmbH, Soest/Westfalen, Germany)
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 40 - 60 %
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 female rabbits
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze pads and elastic tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 4 hours of administration
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours after application
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3/3
Time point:
other: 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
3/3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4

Any other information on results incl. tables

Skin irritation

Time after application

Irritation / Animal No.

Score

Mean score

56

57

58

Erythema

1h

24h

48h

72h

1

1

0

0

2

0

0

0

2

0

0

0

-

1

0

0

-

0.3

0

0

Oedema

1h

24h

48h

72h

1

0

0

0

1

0

0

0

1

0

0

0

-

0

0

0

-

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No classification required.
Executive summary:

Suberg (Bayer AG), 1983

The skin irritation potential of benzothiazole was investigated in 3 female New Zealand White rabbits comparable to OECD guideline 404 with acceptable restrictions. A 2.5 x 2.5 cm area of intact shaved animal skin was used to apply the test substance. Gauze pads were loaded with 0.5 mL benzothiazole and the test areas were covered semiocclusive with elastic tape. The exposure duration was 4 hours. The skin was rinsed 4 hours after application of the test substance. The skin irritation reactions were examined and scored using the Draize method 24, 48 and 72 hours after application. The mean erythema score at 24 hours was 0.3. At the 48 and 72 hour reading points the erythema score was 0.0. The mean oedema score at 24, 48 and 72 hour were 0.0. The criteria for classification are not fulfilled.