Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-11-13 to 1984-11-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions: In deviation from OECD TG 404 occlusive dressing was used.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Produced by Hüls AG, purity > 98 %, main impurities naphthalene and decahydronaphthtalene

Test animals

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.2-2.5 kg
- Number of animals: 3 males, 3 females

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
ADMINISTRATION/EXPOSURE 
- Vehicle: none
- Total volume applied: 0.5 ml
Duration of treatment / exposure:
4 hour(s)
Observation period:
Postexposure period: 14 days
Number of animals:
3 per sex
Details on study design:
ADMINISTRATION/EXPOSURE 
- Area of exposure: 6 cm²
- Occlusion: mull patch, polyethylene film, elastic dressing
- Postexposure period: 14 days
- Removal of test substance: washing with warm water
EXAMINATIONS
- Scoring system: according to Draize
- Examination time points: 1, 24, 48, 72 hours, 6, 9, 11, and 14 days  after administration of the test substance

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
4.55
Max. score:
8
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
3.11
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
1.56
Max. score:
4
Reversibility:
not fully reversible within: 14 days

Any other information on results incl. tables

AVERAGE SCORE 
- Erythema: 3.11
- Edema:  1.56
- Irritation index: 4.55/8 = moderately irritant
REVERSIBILITY: not complete within 14 days

Irritant response data for each animal at each observation time

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

2/2/2/3/2/2

2/2/2/2/2/2

24 h

3/3/3/3/3/3

1/3/2/2/1/1

48 h

3/4/3/3/3/3

1/3/1/2/1/1

72 h

3/4/3/3/3/3

2/3/1/1/1/1

6 days

3/3/2/2/2/2

2/3/1/1/1/1

9 days

Eschar formation for all animals

11 days

Eschar formation for all animals

14 days

Eschar formation for all animals

Average 24h, 48h, 72h

3.11

1.56

Reversibility

Not completely reversible

Applicant's summary and conclusion

Conclusions:
According to the outcome of the skin irritation study tetrahydronaphthalene is considered to be a moderately irritant to skin of rabbits.
Executive summary:

In a primary skin irritation test with three male and three female rabbits tetrahydronaphthalene was applied with occlusive dressing to the shaved back skin at a dose level of 0.5 mL per animal for 4 h. Residual test substance was washed of with warm water. Skin reaction were scored according to OECD criteria at 1h, 24h, 48h, 72h and 6d, 9d, 11d and 14d after application.