1-Naphthalenamine, 1,2,3,4-tetrahydro-, (1S)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study conducted according to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

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

Test material information

Constituent 1

Reference substance name:

1,2,3,4-tetrahydro-1-naphthylamine

EC Number:

218-712-7

EC Name:

1,2,3,4-tetrahydro-1-naphthylamine

Cas Number:

2217-40-5

IUPAC Name:

1,2,3,4-tetrahydronaphthalen-1-amine

Details on test material:

Name of test substance: 1-Aminotetralin
Test substance No.: 05/0560-1
Batch Identification: 7346-05/67 Hauptlauf
Purity: 98.2 area%
Homogeneity: The test substance was homogeneous by visual inspection.
Storage stability: The stability under storage conditions over the study periodwas guaranteed by the sponsor, and the sponsor holds this responsibility.

ADDITIONAL TEST SUBSTANCE INFORMATION
pH-value: ca. 8.5 (undiluted test substance)

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

3 min and 1 h

Observation period:

Readings: Immediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals maximally up to day 15.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: 3 min exposure

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible

Remarks on result:

other: 3 min exposure

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

ca. 3

Max. score:

3

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: 1 h exposure

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

ca. 1

Max. score:

2

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: 1 h exposure

Any other information on results incl. tables

Exposure period of 1 hour

Moderate or marked erythema (grade 2 or 3) was observed in all animals immediately after removal of the patch up to study termination on day 14 or 15. Slight edema (grade 1) was observed in one animal from 24 hours up to 15 days after removal of the patch. Slight edema, noted immediately after removal of the patch up to 48 hours in two animals, increased to moderate (grade 2) after 72 hours or day 7 in one animal, each. In one of these animals moderate edema persisted up to day 7 and decreased to slight again on day 14. Erythema and edema were partly extended beyond the area of exposure during the observation period. Moreover petechiae, dryness of the skin and severe scaling (partly extended beyond the area of exposure) were noted in the animals during the course of the study. The cutaneous reactions were not reversible in all animals within 14 or 15 days after removal of the patch. Moderate erythema, slight edema and severe scaling were still noted in the animals at study termination. Mean scores over 24, 48 and 72 hours for each animal were 3.0, 3.0 and 2.7 for erythema and 1.0, 1.3 and 1.0 for edema.

Applicant's summary and conclusion

Conclusions:

Considering the cutaneous reactions as well as the average score for irritation, 1-hour exposure of 1-Aminotetralin induced irritation of the skin but no corrosive effects under the test conditions. Taking into account these findings together with the results of the EpiDermTM Skin Corrosivity Test (Project-No.: 61H0560/052132) however, it was concluded, that 1-Aminotetralin has a corrosive potential under the test conditions. The results do not indicate a severely corrosive potential of the test substance.

Executive summary:

An in vitro study using the EpiDerm™ human skin model showed the corrosivity of 1-Aminotetralin. In order to allow a clear differentiation of the corrosive potential of the test substance for classification purposes a dermal irritation/corrosion test in White New Zealand rabbits was performed according to the method described in OECD guideline 404. An amount of 0.5 mL of the test substance was applied for 3 minutes and 1 hour to the intact skin of three rabbits. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and then in weekly intervals until day 14 or 15. After the exposure period of 3 minutes slight or moderate erythema, partly extending beyond the area of exposure, were observed in all animals during the course of the study. In addition, slight edema was noted in a single animal 24 hours after removal of the patch. The cutaneous reactions were reversible within 7 days after removal of the patch at latest. The average score (24 to 72 hours) for irritation was calculated to be 1.0 for erythema and 0.1 for edema. The exposure period of 1 hour caused moderate or marked erythema and slight or moderate edema, both partly extended beyond the area of exposure, in the animals during the whole observation period. Moreover petechiae, dryness of the skin and severe scaling (partly extended beyond the area of exposure) were noted in the animals during the course of the study. The cutaneous reactions were not reversible in all animals within 14 or 15 days after removal of the patch. Moderate erythema, slight edema and severe scaling were still noted in the animals at study termination. The average score (24 to 72 hours) for irritation was calculated to be 2.9 for erythema and 1.1 for edema. Considering the described cutaneous reactions as well as the average score for irritation, 1-hour exposure of 1-Aminotetralin induced irritation of the skin but no corrosive effects under the test conditions. Taking into account these findings together with the results of the EpiDermTM Skin Corrosivity Test (Project-No.: 61H0560/052132) however, it was concluded, that 1-Aminotetralin has a corrosive potential under the test conditions chosen. The results do not indicate a severely corrosive potential of the test substance.