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

Eye irritation

Administrative data

Endpoint:

eye 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: Federal Register Vol 38, no 187, S. 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 / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG breeding colony
- Strain: SPF-Albino-Himalayan, Hoe HIMK(SPFWiga)
- Housing: single cage
- Diet: ERKA 8300, ad libitum
- Water: tap water, ad libitum

Test system

Vehicle:

other: propandiol 1,2

Controls:

other: untreated right eyes served as control

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h after beginning of treatment

Number of animals or in vitro replicates:

6

Details on study design:

One time application of the substance to the conjunctival sac of the left eye of each animal, the right eye served as control respectively

- Washing: washing with physiological saline 24 h after administration

- After the 24 h readings a droplet of a 0.01 % solution of fluorescein sodium was applied for the 48 and 72 h readings

- The eyes are examined and the grade of ocular reaction is recorded at 1, 24, 48, and 72 hours after administration

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 h

Score:

28

Max. score:

110

Reversibility:

not specified

Remarks on result:

probability of moderate irritation

Remarks:

according to the FDA scoring system

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 21 days according to effective guidelines.

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 since the test conditions are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points.

Executive summary:

Test material was subject to a test of eye irritancy according to FDA Guideline. 100 mg of substance were applied to one eye of six rabbits. Mean values of the 24, 48 and 72 h readings after beginning of treatment were calculated for each animal. Only slight effects (conjunctival redness mean score: 1.4; chemosis mean score: 0.8; corneal opacity mean score: 0.8; iridial effects mean score: 0, below

the threshold for classification were determined.

All effects are expected to be fully reversible.

Based on these findings the test material was judged not to be irritating to the eye.