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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 11, 1983 to April 28, 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
OECD guidelines for testing of chemicals: Acute Eye Irritation/Corrosion No. 405, adopted May 12, 1981 by the OECD Council.
Deviations:
no
Principles of method if other than guideline:
None
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Company code: FAT 31'016/I
- Batch No.: RZ 3068/37,
- Appearance: powder
- Stability of the test compound: until October 2012
- Teat article received: October 25, 1982

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: Kleintierfarm Madoerin AG, CH-4414, Fuellinsdorf.
The test was performed on 3 female New Zealand white rabbits weighing 2.3 to 2.6 kgs and aging between 12-14 weeks. They were housed individually in metal cages, were kept in a room maintained at a constant temperature of 20±3 °C, at a relative humidity of 30-70% and on a 12 hours light cycle day, with approximately 15 air changes/h. The animals received ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG (Switzerland) and water. Prior to treatment they were acclimatized to the laboratories for a minimum of 4 days. Only rabbits with normal ophthalmic findings were used for these tests.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye was not treated and served as the control.
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
Not specified
Observation period (in vivo):
17 days
Number of animals or in vitro replicates:
3 females
Details on study design:
- Application of the test article:
0.1 g of FAT 31016/I was placed into the conjunctival sac of the right eye of each rabbit, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in
order to prevent loss of the test material.

- Scoring and assessment of local reactions:
The ocular reactions were examined 1, 24, 48, and 72 hours after substance instillation and again during the following observation period.
The irritating and/or corrosive potential of the test article (theoretical range: non irritant - extremely irritant) was assessed on the basis of the maximum irritant effect observed
- in one or several of the ocular tissues (conjunctiva, iris, cornea), observed over the range of observation time
- in one or more animals
and taking into account the reversibility of the effect.

- Symptoms: daily (a.m. and p.m. on working days, once daily on weekends and holidays)
- Body weight: at begin of the acclimatisation and end of test
- Mortality: daily (a.m. and p.m. on working days, once daily on weekends and holidays)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
not fully reversible within: 17 d
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
not fully reversible within: 17 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.78
Max. score:
3
Reversibility:
not fully reversible within: 17 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2.78
Max. score:
4
Reversibility:
not fully reversible within: 17 d

Any other information on results incl. tables

Irritation scores

Corneal opacity
Animal Observation time
1 hour 24 hours 48 hours 72 hours 7 days 17 days
4 2 2 3 3 3 3
5 2 2 3 3 4 4
6 2 2 3 2 4 4
Mean 2.00 2.00 3.00 2.67 3.67 3.67

Iris
Animal Observation time
1 hour 24 hours 48 hours 72 hours 7 days 17 days
4 1 1 1 1 2 2
5 1 1 2 2 2 2
6 1 1 1 2 2 2
Mean 1.00 1.00 1.33 1.67 2.00 2.00

Conjunctiva redness
Animal Observation time
1 hour 24 hours 48 hours 72 hours 7 days 17 days
4 2 3 2 2 2 2
5 3 3 3 3 3 3
6 3 3 3 3 2 2
Mean 2.67 3.00 2.67 2.67 2.33 2.33

Chemosis
Animal Observation time
1 hour 24 hours 48 hours 72 hours 7 days 17 days
4 2 3 2 2 2 2
5 3 3 3 3 4 4
6 3 3 3 3 2 2
Mean 2.67 3.00 2.67 2.67 2.67 2.67

Observations other than skin reactions:

The body weight development was not affected by the application of the test article.

No other reactions to treatment were recorded during the whole observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
FAT 31016/I was considered to be an eye irritant.
Executive summary:

The eye irritation potential of FAT 31016/I was evaluated as per OECD Guideline 405. The test was performed on 3 female rabbits. 0.1 g test substance was placed into the conjunctival sac of the right eye of the rabbits. The left eye was not treated and served as an untreated control. The eye irritation was appraised after 1 hour and on Days 1, 2, 3, 7 and 17 and was scored for each individual rabbit. Insertion of the substance in the eye did lead to irritation. The mean scores (24, 48 and 72 hours) for corneal opacity, iris, conjunctival redness and chemosis were calculated to be 2.6, 1.33, 2.78 and 2.78 respectively. The individual scores were found to meet the criteria of classification as per CLP (Regulation EC No. 1272/2008). Further, the reactions were not reversible within 17 days. Hence, FAT 31016/I should be considered to be an eye irritant and should be classified in category 2, 'irritating to eyes'.