Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cremophor Vorstufe
- Lot/batch No.: 58

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: SAVO; MED. versuchstierzuchten GMBH, 7964 Kisslegg/Allgau, FRG
- Weight at study initiation: males 2.44 and 2.56 kg and female 2.62 kg
- Housing: One animal per cage, stainless steel with wire mesh walk floors (floor area: 40 x 51 cm). No bedding in the cages.
- Diet: Kliba 341, 4 MM; Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, about 130 g per animal per day.
- Water: About 250 mL tap water per animal per day
- Acclimation period: at least 8 days before study start

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL undiluted
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
- Application: Single instillation into the conjunctival sac of the right eyelid
- The test substance was not washed out.
- Readings: 1 h, 24 h, 48 h and 72 h after instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, and #3
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, #2, and #3
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, and #3
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3
Time point:
other: mean 24, 48, and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Clearly increased discharge was observed in all animals 1 hour after instillation of the test substance. Slight conjunctivae redness was observed in two animals and was fully reversible within 48 hours.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information