Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 25 FEB 1997 to 7 MAR 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (EU B5/OECD 405). For justification of read-across within the category please see chapter 1 of the Chemical Safety Report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hoechst Wachs E
- Substance type: light yellow substance
- Physical state: solid
- Storage condition of test material: darkness at room temperature in a fume cupboard

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation:
- Weight at study initiation: 2.4-3.1 kg
- Housing: individually
- Diet: ssniff K-H (V2333) ad libitum)
- Water: ad libitum
- Acclimation period: 1 week under study conditions


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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
100 mg of test substance
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with isotonic saline at approx. 37 °C
- Time after start of exposure: 24 h, at all other examination time points at which treated eyes showed discharge and after fluorescein treatment


SCORING SYSTEM: according to guidelines


TOOL USED TO ASSESS SCORE: fluorescein

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: no effects observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Redness; individual mean scores: 0.00; 0.33; 0.33, the maximum score observed was 1.0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: grade 1 chemosis was observed at 1 h post exposure
Other effects:
All 3 animals showed a clear, colourless discharge 1 h after end of exposure (grade 2, moistening of lids and hairs adjacent to the lids). No discharge was observed at 24 h post exposure.

Any other information on results incl. tables

The maximum conjunctivae score of the 3 tested animals at 1 h after end of exposure was 1, 2 and 2, respectively. The maximum chemosis score at 1 h after end of exposure was 1 in all tested animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The undiluted test substance was not irritating to the eyes of rabbits.
Executive summary:

The undiluted test substance (Hoechst Wachs E) was applicated to the eyes of 3 rabbits and removed 24 h later. The treatment caused a slight, transient reddening of the conjunctiva (mean score for 24-48-72 h: 0.22), but no iris effects, cornea opacity or chemosis. All 3 animals showed a clear, colourless discharge 1 h after end of exposure (grade 2, moistening of lids and hairs adjacent to the lids). No discharge was observed at 24 h post exposure.