Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 July 1992 - 24 July 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Although a good quality report and conducted to GLP and documented test parameters are based on specific national guidelines, the purity of test substance is not reported and actual guideline references are not quoted in test report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
The study report includes a statement signed by the study director confirming that the study was conducted in accordance with the principles of Good Laboratory Practice, however the report does not include a GLP certificate issued by an official body (suc

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MMB-AC
- Physical state: Colourless liquid
- Lot/batch No.: 32840
- Storage condition of test material: Stored in the dark, under ambient conditions.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Limited, Abbots Ripton Road, Wyton, Huntingdon, Cambs, PE17 2DT
- Weight at study initiation: 3.2-3.3 kg
- Housing: Individual aluminium cages with grid floors beneath which were absorbent paper lined trays
- Food: ad libitum Standard Rabbit Diet, supplied by Special Diets Services Limited, 1 Stepfield, Witham, Essex, CM8 3AD,
- Water: ad libitum tap water
- Acclimation period: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22°C
- Humidity (%): 55
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: One eye was left untreated in each animal, which served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) 0.1ml
Duration of treatment / exposure:
N/A
Observation period (in vivo):
1, 24, 48 and 72 hours after instillation
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: N/A

SCORING SYSTEM: OECD recommended scoring system

TOOL USED TO ASSESS SCORE: Hand held magnifier and pen torch.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
other: Not applicable - no irritation seen
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0 - 1
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Iris score of 1 seen in one animal at 1 hour time point.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Conjunctivae score of 1 seen in all animals at 1 hour time point
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Chemosis score of 1 seen in one animal at 1 hour time point
Irritant / corrosive response data:
All rabbits were noted to groom the treated eye immediately after dosing which is indicative of a stinging effect.
No corneal responses were noted. Slight conjunctival redness was noted in all 3 treated eyes at 1 h post instillation. In addition, one treated eye showed a slight iridial response and slight chemosis at 1h. Full recovery of all treated eyes was noted at 24 h post instillation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Results reviewed with reference to Directive 67/548/EEC. Criteria used for interpretation of results: EU
Conclusions:
The test material is slightly irritant to rabbit eyes.
Executive summary:

The eye irritation potential of a test material, MMB-Ac, was investigated in 3 New Zealand White rabbits.

Slight conjunctival redness (score I) was noted in all treated eyes at I h post instillation. In addition, one of the treated eyes showed a slight iridial response and slight chemosis at 1 h. Full recovery was noted at 24 h post instillation.

MMB-Ac is slightly irritant to rabbit eyes.