Registration Dossier

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:
other: Guideline study, available as unpublished report, performed in a reliable laboratory (BASF), signed by key scientists, no GLP certificate, but otherwise acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- C5 produkt
- no data (reported as available in the raw data)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Savo med Versuchsteirzuchten, GMBH, FRG
- Age at study initiation: no data
- Weight at study initiation: mean: 3.18 kg
- Housing: In stainless steel wire mesh cages
- Diet: Kliba 341 (approximately 130 g per animal per day)
- Water: approximately 250 mL per animal per day
- Acclimation period: At least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes: Fully air conditioned
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: Dosed: 11 December 1989

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the eyes were not washed

SCORING SYSTEM:
- According to the 83/467/EEC criteria of July 29th 1983
- Eyes examined at 1, 24, 48 and 72 hours after application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hrs
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 hours
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hrs
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The overall mean score for conjunctival redness was 0.3, and for chemosis was 0.2. All eyes were normal 72 hours following instillation of the test substance.
Executive summary:

C5 Produkt (CAS 92128 -68 -2) was non irritating to the rabbit eye and does not warrant classification under DPD or GHS/CLP.