Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Short report, no GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
pre-dates GLP regulation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Morton commercial rabbits, Parsonage farm, Stansted, UK
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2,44 to 2,7 kg
- Housing: single, grid floor cages
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum):ad lib.
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 21
- Humidity (%): 48 to 62
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10/ 14

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 h after instillation

SCORING SYSTEM: acc. to Draize (1949)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hr
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
0
Irritant / corrosive response data:
Conjunctival irritation, identified by moderate redness, slight to moderate swelling and discharge, was noted in the 3 treated animals one hour after treatment. At the 24 hour observation all 3 rabbits showed moderate redness of the conjunctival membranes. The conjunctival irritation regressed and all eyes appeared normal on day 7.
No corneal opacity or iridtal inflarnmation was noted during the study period.
The hair adjacent to the eye was stained brown by the test article.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information slight effects not sufficient for classification Criteria used for interpretation of results: EU
Conclusions:
The test material was a mild irritant to the rabbit eye.
Executive summary:

A study was performed to assess the irritant effects of the test material on the eye of the New Zealand White rabbit. The protocol was designed to meet the requirements of Annex Vof the EEC Council Directive 79/831/EEC, the Organisatfon for Economic Co-operation and Development (OECD) and the HSE Approved Code of Practice Notification of New Substances Regulations 1982.

The instillation of 100 mg of solid Brown HH 469 produced positive eye effects in the conjunctivae of the 3 animals one and 24 hours after treatment. The test article was regarded as a mild irritant to the rabbit eye.