Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles. Conducted prior to implementation of OECD and GLP guidelines.

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

Constituent 1
Chemical structure
Reference substance name:
4'-chloro-3-hydroxy-2-naphthanilide
EC Number:
202-189-7
EC Name:
4'-chloro-3-hydroxy-2-naphthanilide
Cas Number:
92-78-4
Molecular formula:
C17H12ClNO2
IUPAC Name:
N-(4-chlorophenyl)-3-hydroxynaphthalene-2-carboxamide

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:
Onetime 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

- Tool to assess score after 48 and 72 h: 0.01 % solution of fluorescein sodium

The eyes are examined and the grade of ocular reaction is recorded at 1, 7, 24, 48, and 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all tested animals
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
1.1
Max. score:
4
Reversibility:
not fully reversible within: 72 h after beginning of treatment (end of observation) for 3 of 6 animals
Remarks on result:
other: highest mean score of a single animal: 1.3 each for 3 of 6; 4 of 6 animals have a mean score of >=1
Irritation parameter:
iris score
Basis:
animal: # 1-6 each
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effect occured
Remarks on result:
other: no effect on any single animal
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all tested animals
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 h after beginning of treatment (end of observation) for 5 of 6 animals
Remarks on result:
other: highest mean score of a single animal: 2.3 for 1 of 6; 5 of 6 animals have a mean score of >=2
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all tested animals
Time point:
other: mean of 24, 48, 72 h after beginning of treatment
Score:
2.1
Max. score:
4
Reversibility:
not fully reversible within: 72 h after beginning of treatment (end of observation) for 5 of 6 animals
Remarks on result:
other: highest mean score of a single animal: 3.0 for 1 of 6; 5 of 6 animals have a mean score of >=2
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:
Category II
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is classified as H319 according to Regulation (EC) no. 1272/2008.

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 animals. Mean values of the 24, 48 and 72 h readings after beginning of treatment were calculated for each animal. Relevant effects

(conjunctival redness mean score: 2.0; chemosis mean score: 2.1; corneal opacity mean score: 1.1; iridial effects mean score: 0) for

classification were determined. All effects were fully reversible or expectded to be fully reversible. Based on these findings the test material was judged to be irritating to the eye.