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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
details about test substance, animal source/breeder, in life dates and animal enviroment (air changes per hour) are missing

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act
Version / remarks:
Sect.191.12 (February 1965)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
12 May 1981 / The study was performed before the guideline was published.
Deviations:
yes
Remarks:
period of treatment different to guideline, slightly different scoring system
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: /
- Age at study initiation: 17-20 weeks
- Weight at study initiation: 3.09 kg male and 3.10 kg female
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum, sterile
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50-70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 10h, 8-18.00 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
1 s eye held closed, 30 s treatment with open eye
Observation period (in vivo):
1, 24, 48 and 72 h
Number of animals or in vitro replicates:
5 male, 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water 200 ml
- Time after start of exposure: 30 sec

SCORING SYSTEM:
Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.

The eye reactions were assessed as follows:

Score : Assessment
0 non irritant
>0 - 10 minimally irritant
11 - 25 slightly irritant
26 - 56 moderately irritant
57 - 84 markedly irritant
> 84 extremely irritant


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1h
Score:
10
Max. score:
80
Remarks on result:
other: washed and unwashed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h
Score:
5
Max. score:
80
Remarks on result:
other: 3 unwashed, 1 washed
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48h
Score:
5
Max. score:
80
Reversibility:
fully reversible within: 72h
Remarks on result:
other: unwashed only
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h
Score:
ca. 5
Max. score:
20
Remarks on result:
other: washed and unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h
Score:
2
Max. score:
20
Remarks on result:
other: washed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h
Score:
5
Max. score:
20
Remarks on result:
other: unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48h
Score:
2
Max. score:
20
Remarks on result:
other: washed and unwashed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72h
Score:
ca. 1
Max. score:
20
Reversibility:
fully reversible within: 6d
Remarks on result:
other: unwashed
Irritant / corrosive response data:
Conjunctiva.
A very slight to slight reaction was seen in all treated eyes one hour after the application of the compound. There was very little change by 24 hours. These had returned to normal as follows: 48 hours (one washed eye), 72 hours (one unwashed and 2 washed eyes) and 6 days (2 unwashed eyes).
Cornea.
Slight opacity with damage to the surface epithelium was seen in all treated eyes at one hour. This was still present in the 3 unwashed and one washed eye at 24 hours. These had returned to normal as follows: 48 hours (one washed eye), 72 hours (2 unwashed eyes) and 6 days (one unwashed eye).

Generally, washed eyes tended to show a slightly less severe reaction than unwashed eyes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is a minimal eye irritant but based on the results, there is no indication for an irritating effect based on GHS.
Executive summary:

In the eye irritation test, similar to OECD 405, male and female New Zealand White rabbits were treated with the test substance as such.

Five male and one female were singly housed.

After the test substance was applied to one eye, the lid was closed for 1 second and left open for 30 seconds. Afterwards, the eye was washed with warm water and observed 1, 24, 48 and 72 hours after application. The right eye of each animal seved as control.

The slight reactions were reversible within 24 hours after application. Generally, washed eyes tended to show a slightly less severe reaction than unwashed eyes.

The test substance is not considered to be eye irritant to rabbits.