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: Screening study for suspected highly irritant substances. Some details on methods not available

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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): MHAC-P

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese white
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

Test system

Vehicle:
other: Undiluted and 10% in olive oil
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted and 10% in olive oil
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
Up to 28 days
Number of animals or in vitro replicates:
3/group
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: fluorescein staining to aid assessment of corneal opacity

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 28 days
Remarks on result:
other: Undiluted substance
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 28 days
Remarks on result:
other: Undiluted substance
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
not fully reversible within: 28 days
Remarks on result:
other: Undiluted substance
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Undiluted substance
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Undiluted substance
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 24 days
Remarks on result:
other: Undiluted substance
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Undiluted substance
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: Undiluted substance
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 25 days
Remarks on result:
other: Undiluted substance
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: Undiluted substance
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 17 days
Remarks on result:
other: Undiluted substance
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 17 days
Remarks on result:
other: Undiluted substance

Any other information on results incl. tables

Undiluted substance – Corneal effects noted in at least one animal within 3 hours of exposure, increasing to a maximum after 6 days. Some recovery apparent after 13 days but full reversibility not apparent within 28 days. Iris effects first noted 48 hours after exposure with full recovery apparent within 24 days. Marked chemosis observed within 1 hour of exposure, reaching a maximum (score) after 2 hours. Severity of response decreased with time and recovery apparent 17 days after exposure. Conjunctival reaction noted in at least one animal within 1 hour of exposure, response reaching its greatest after 24 hours. Full recovery occurred within 25 days.

 

10% concentration in olive oil – Corneal effects noted in at least one animal within 3 hours of exposure, increasing in incidence/severity to its highest level 5 days after exposure. Full recovery apparent after 11 days. Iris effects first noted 24 hours after exposure with full recovery not apparent within 28 days. Marked chemosis observed within 1 hour of exposure, reaching a near maximum (score) after 2 hours. Severity of response decreased with time and recovery apparent 9 days after exposure. Conjunctival reaction noted in at least one animal within 1 hour of exposure, response reaching its greatest after 72 hours. Full recovery occurred within 11 days.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The undiluted substance is highly irritating to the eye with effects not fully reversible within 28 days of exposure
Executive summary:

Eye irritation has been assessed in the rabbit using methods essentially similar to those described by OECD/EU test guidelines. The severity of response and lack of full reversibility was such that the substance was judged to be highly irritating/corrosive to the eye.