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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:
From 22 NOV 1988 to 25 NOV 1988.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 405).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.8-3.2 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage), ad libitum, plus hay ca. 15 g per day
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml, ca. 20 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiol. saline, ca. 37 °C warm
- Time after start of exposure: 24h

SCORING SYSTEM: according to OECD TG 405

TOOL USED TO ASSESS SCORE: fluorescein, UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #3
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible
Remarks:
48 h after application
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Remarks:
48 h after application
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study. Conjunctival redness was observed in every animal 1 h and 24 h after application (max. score 2), fully reversible by 48 h after application. Chemosis was observed only in animal #3 (score 1) one hour after application, fully reversible by 24 h after application. 48 h and 72 h after application no ocular effects were observed.
Other effects:
Transparent discharge with yellow discolouration from test substance one hour after application.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions.
Executive summary:

The test material was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. No corneal or iridial effects were noted during the study. Slight conjunctival effects were observed in every animal, fully reversible by 48 hours after application. Chemosis was observed only in animal #3 one hour after application, fully reversible by 24 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.