3-hydroxy-4'-methoxy-2-naphthanilide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20.-23.03.1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FDA guideline (§ 1500.41, Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)

GLP compliance:

no

Remarks:

conducted prior to GLP guideline implementation

Test material

Test material information

Constituent 1

Reference substance name:

3-hydroxy-4'-methoxy-2-naphthanilide

EC Number:

202-190-2

EC Name:

3-hydroxy-4'-methoxy-2-naphthanilide

Cas Number:

92-79-5

Molecular formula:

C18H15NO3

IUPAC Name:

3-hydroxy-4'-methoxy-2-naphthanilide

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG breeding colony
- Strain: SPF-Albino-Himalayan, Hoe HIMK(SPFWiga)
- Weight at study initiation: 1,5 - 2,0 kg
- Housing: single cage
- Diet: ERKA 8300, ad libitum
- Water: tap water, ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped intact and clipped scarified

Vehicle:

other: propandiol 1,2

Controls:

not required

Amount / concentration applied:

0.5 g mixed with 0.6 ml propandiol 1,2

Duration of treatment / exposure:

24 h

Observation period:

72 h after beginning of treatment

Number of animals:

6

Details on study design:

0.5 g of the test substance mixed with 0.6 ml propandiol 1,2 and placed on a square gauze patch, 2,5 x 2,5 cm of size, was applied on a clipped/intact and clipped/scarified skin of the albino rabbit. The patches were fixed by an adhesive tape and additionally covered by a neutral, impermeable PVC film. The entire trunk of the animal was then wrapped with an elastic bandage. After 24 hours of exposure the patches were removed and the reactions were examined. Follw-up examinations were made 48 h and 72 h after beginning of treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: mean of 24, 48, 72 h after beginning of treatment

Score:

0.7

Max. score:

4

Reversibility:

not fully reversible within: 72 h after beginning of treatment (end of observation)

Remarks on result:

other: shaved intact

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: mean of 24, 48, 72 h after beginning of treatment

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant because of lacking effects

Remarks on result:

other: shaved intact

Irritant / corrosive response data:

In view of the shortened observation period and the slightness of effects a full recovery is expected in the case of a prolonged observation period of 14 days according to effective guidelines.

Other effects:

no other effects reported

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Classification acc. to (EC) 1272/2008: not irritating

This conclusion is legitimate even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements.

Executive summary:

The test material was tested for skin irritancy according to FDA guideline. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance for 24 h under occlusive conditions and the skin responses were examined at 24, 48, and 72 h after beginning of treatment. Mean values of the 24, 48 and 72 h readings were calculated for each animal. Only slight effects (erythema mean score: <=1, edema mean score: 0) below the threshold for classification were determined for the intact skin. All effects were fully reversible or expected to be fully reversible. Similar results were obtained for scarified skin. Based on these findings the test material was judged not to be irritating to skin.