Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 April 1980 - 22 April 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Protocol complies with scientifically accepted methods, and is sufficiently detailed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: Dutchland Laboratories, Inc. Denver, PA. USA.

- Age at study initiation: approximately 14 weeks of age.

- Weight at study initiation: average for male was 2433 g, average for female was 2412g.

- Housing: animals were maintained individually in screen bottom cages in temperature and humidity controlled quarters.

- Diet (e.g. ad libitum): No data available.

ENVIRONMENTAL CONDITIONS
-Temperature (°C): controlled environment, but no temperature provided.

-Humidity (%):controlled environment, but no humidity information provided.

-Air changes: controlled environment, but no air change information provided.

-Photoperiod: controlled environment, but no photoperiod information provided.


IN-LIFE DATES: From: 04/09/1980 To: 04/20/1980.

- Water (e.g. ad libitum): ad libitum.

- Acclimation period: at least 7 days under laboratory conditions.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 ml

- Concentration (if solution): undiluted.


VEHICLE

- Amount(s) applied (volume or weight with unit): Not applicable.

- Concentration (if solution): Not applicable.

- Lot/batch no. (if required): Not applicable.

- Purity: Not applicable.
Duration of treatment / exposure:
The test material was not washed, so animal exposure to test material for the entire test period.
Observation period (in vivo):
The treated eyes were observed at 24, 48, 72 and 96 hour after treatment.
Number of animals or in vitro replicates:
3 male and 3 female
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): None.

- Time after start of exposure: Not applicable.

SCORING SYSTEM: Draize score system.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Primary Eye Irritation Score
Basis:
mean
Time point:
other: hour
Score:
24
Max. score:
0.7
Reversibility:
fully reversible within: 96 hours
Irritation parameter:
other: Primary Eye Irritation Score
Basis:
mean
Time point:
other: hours
Score:
48
Max. score:
0.3
Reversibility:
fully reversible within: 96 hours
Irritation parameter:
other: Primary Eye Irritation Score
Basis:
mean
Time point:
other: hours
Score:
72
Max. score:
0.3
Reversibility:
fully reversible within: 96 hours
Irritant / corrosive response data:
See Table 1 and Table 2 for individual animal data
Other effects:
None

Any other information on results incl. tables

Table 1. Body Weight Data

 

Animal No.

Initiation

Terminal (day 7)

Male

1

2398

2527

2

2452

2592

3

2418

2511

Average

2423

2543

Female

4

2403

2482

5

2501

2409

6

2332

2333

Average

2412

2408

Table 2. Individual Data for ocular Reactions

Sex

Male

Female

Animal No.

1

2

3

4

5

6

 

 

 

24 h

Cornea

-   Opacity

-   area

 

0

0

 

0

0

 

0

0

 

0

0

 

0

0

 

0

0

Iris

0

0

0

0

0

0

Conjunctivae

-   Redness

-   Chemosis

-   Discharge

 

0

0.5

0

 

0

0

0

 

0

0

0

 

0

0

0

 

0.5

0

0

 

1.0

0

0

 

 

 

48 h

Cornea

-   Opacity

-   area

 

0

0

 

0

0

 

0

0

 

0

0

 

0

0

 

0

0

Iris

0

0

0

0

0

0

Conjunctivae

-   Redness

-   Chemosis

-   Discharge

 

0

0

0

 

0

0

0

 

0

0

0

 

0

0

0

 

0.5

0

0

 

0.5

0

0

 

 

 

72 h

Cornea

-   Opacity

-   area

 

0

0

 

0

0

 

0

0

 

0

0

 

0

0

 

0

0

Iris

0

0

0

0

0

0

Conjunctivae

-   Redness

-   Chemosis

-   Discharge

 

0

0

0

 

0

0

0

 

0

0

0

 

0

0

0

 

0

0

0

 

0

0

0

Sodium Fluorescein Examination

 

-ve

 

-ve

 

-ve

 

-ve

 

-ve

 

-ve

 

 

 

96 h

Cornea

-   Opacity

-   area

 

0

0

 

0

0

 

0

0

 

0

0

 

0

0

 

0

0

Iris

0

0

0

0

0

0

Conjunctivae

-   Redness

-   Chemosis

-   Discharge

 

0

0.5

0

 

0

0

0

 

0

0

0

 

0

0

0

 

0

0

0

 

0

0

0

Primary Eye irritation scores

24 h: 0.7

48 h: 0.3

72 h: 0.3

96 h: 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: FHSA regulations
Conclusions:
Test eyes treated with the substance did not exhibit ocular effects at all time points observed throughout the study. Following assessment of the data for all endpoints, the test material is not a primary eye irritant
Executive summary:

In a study to evaluate the ocular irritancy potential of the substance using New Zealand White strain rabbit. The substance did not cause any ocular effects therefore it is not a primary eye irritant.