1,2,3,4-tetrahydronaphthalene

Skin irritation / corrosion

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3,4-tetrahydronaphthalene

EC Number:

204-340-2

EC Name:

1,2,3,4-tetrahydronaphthalene

Cas Number:

119-64-2

Molecular formula:

C10H12

IUPAC Name:

1,2,3,4-tetrahydronaphthalene

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 or test system 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

Results

Results 1

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

Results 2

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

Results 3

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 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.