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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 2 AUG 1988 to 5 AUG 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

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: approx. 3 to 5 months
- Weight at study initiation: 3.2 to 3.7 kg
- Housing: single caged in fully conditioned rooms
- Diet: Altromin 2123 rabbit diet (Altromin GmbH, Lage/Lippe, Germany), ad libitum; hay, approx. 15 g/d
- Water: deionised, chlorinated water, ad libitum

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 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: with physiological solution of sodium chloride (37 °C)
- Time after start of exposure: 24 h (and at every reading when discharge of the eyes occurred or sodium-fluorescein was used for scoring)

SCORING SYSTEM: according to OECD TG 405

TOOL USED TO ASSESS SCORE: at 48 and 72 h reading 1 drop of sodium-fluorescein (0.1%) added for scoring

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
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
- Conjunctival redness was observed in 3/3 animals at one hour after instillation of the test item (score (redness): 1) as well as in 2/3 animals at the 24 h reading. This effect was fully reversible by 48 hours after application.
- No effects on cornea, iris, or chemosis occurred (score 0 at every time point)
Other effects:
There was discharge observed in all animals one hour after instillation of the test material.

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. Test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

Test material was subject to an acute eye irritation/corrosion test in 3 rabbits according to OECD TG 405. No corneal or iridial effects were observed. Chemosis was not found likewise. Conjunctival redness was observed in 3/3 animals at one hour after instillation of the test item (score (redness): 1) as well as in 2/3 animals at the 24 h reading. This effect was fully reversible by 48 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.