Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

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, company breeding colony
- Strain: Albino New Zealand rabbit, normal breeding
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 3.4 - 3.9 kg
- Housing: single cages arranged in a battery
- Diet: Altromin 2123 ad libitum + straw
- Water : de-ionized and chlorinated water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 +/- 20
- Lighting time: 12 h daily

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eyes served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days after beginning of treatment
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #72, 77, 79 each
Time point:
other: mean of 24, 48, 72 h reading
Score:
0
Max. score:
4
Reversibility:
other: initial slight signs of irritation (cornea) were fully reversible within 24h
Irritation parameter:
iris score
Basis:
animal: #72, 77, 79 each
Time point:
other: mean of 24, 48, 72 h reading
Score:
0
Max. score:
2
Reversibility:
other: initial slight signs of irritation (iris) were fully reversible within 24h
Irritation parameter:
conjunctivae score
Basis:
animal: #72
Time point:
other: mean of 24, 48, 72 h reading
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: #77
Time point:
other: mean of 24, 48, 72 h reading
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: #79
Time point:
other: mean of 24, 48, 72 h reading
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: #72
Time point:
other: mean of 24, 48, 72 h reading
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: #77
Time point:
other: mean of 24, 48, 72 h reading
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: #79
Time point:
other: mean of 24, 48, 72 h reading
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
discharge at the 1 h reading was fully reversible within 24 h.
Other effects:
No other effects reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the test results the substance does not meet criteria for classification concerning serious eye damage/eye irritation as laid down in Regulation (EC) No 1272/2008.
Executive summary:

Test material was subject to a test of serious eye damage/eye irritation according to OECD Guideline 405. 100 mg of substance were applied to one eye of each of three animals. Mean values of the 24, 48 and 72 h readings were calculated for each animal. Only slight effects (conjunctival redness mean score: <=1.7, conjunctival chemosis mean score: <=0.7, corneal opacity mean score: 0, and iritis mean score: 0) below the threshold for classification were determined. All effects were fully reversible. Based on these findings the test material was judged not to be seriously eye damaging or eye irritating.