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
Study period:
January 13 to january 17, 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study was conducted in accordance with a recognized scientific procedure for analyzing the primary eye irritation of a test material in experimental animals. The test was performed on a 40% formulation. Study details were sufficient to support the conclusions in the report regarding the eye irritation of the formulated test material.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: EEC Directive 79-831, Annex V, methods for the determination of toxicity, B.5., Acute toxicity, eye irritation, dated December 1983
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: white coarse powder
- Analytical purity: 40 %, range meta/para not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, the Netherlands
- Weight at study initiation: 2500-3000 g
- Housing: individually in galvanized cages
- Diet and water : ad libitum
- Acclimation period:


ENVIRONMENTAL CONDITIONS
- Temperature: 15-21 °C
- Humidity: 40-70 %
- Air changes : 10 per hr
- Photoperiod : 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Concentration: 0.1 g of test material was instilled into the everted lower eye lid of one eye of each rabbit.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Comment: not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: after one hour, 24 hours, 48 hours and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: after one hour, 24 hours, 48 hours and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: after 24, 48 and 72 hours
Score:
0.6
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: after 24, 48 and 72 hours
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 72 hours

Any other information on results incl. tables

The scores recorded for cornea and iris were zero (0) in all
rabbits at all reading times. A maximum score of 2 (slight
to moderate) for redness and 2 (slight to moderate swelling)
for chemosis were observed in 2/3 rabbits after 1 hour. At
24 hours only 1/3 rabbits still had a score of 2 for
redness, all other scores were 1 or 0. 2/3animals had a
score of 1 for redness, and 1/3 had a score of 1 for
chemosis at 48 hours. At 72 hours all scores were zero (0).
The laboratory stated that the test material was not an eye
irritant based upon the EEC standards for evaluation.

  Rabbit Opacity Iris Redness Chemosis
After one hour 1 0 0 2 1
2 0 0 2 2
3 0 0 1 1
After 24 hours 1 0 0 1 0
2 0 0 2 1
3 0 0 1 0
After 48 hours 1 0 0 0 0
2 0 0 1 1
3 0 0 1 0
After 72 hours 1 0 0 0 0
2 0 0 0 0
3 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Directive 67/548/EEC and CLP
Conclusions:
The test material was not an eye irritant based upon the EEC standards for evaluation.
Executive summary:

The potential of the peroxide to induce ocular irritation was evaluated in rabbits according to OECD405 guideline.

The substance was administered to three male New Zealand White rabbits.

A single dose of 0.1 g of the substance was instilled into the left/right conjunctival sac. The right/left eye was not treated and served as control. The eyes were not rinsed after administration of the test item.

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration of the test substance. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.

After one hour, the eyes effects observed in all rabbits consisted of slight or moderate redness and slight or moderate swelling of the consjunctivae. All these clinical signs were fully reversible within 72 hours.

Mean scores calculated for each animal over 24, 48 and 72 hours were (0) (0.6) and (0) for chemosis, (0.3) (1) and (0.6) for redness of the conjunctiva, (0) (0) and (0) for iris lesions and (0) (0) and (0) for corneal opacity.

Under these experimental conditions, the test item was considered as sligh irritant when administered by ocular route to rabbits.