Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 23 to 30 July 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study run to a reliable method but not to GLP and no guideline followed

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Three male and three female rabbits were tested in this study. The test substance placed in to the right eye, the other eye remained untreated to serve as a control. The ocular reaction was recorded at 1 h, 24 h and 2, 3 and 7 days after treatment.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Cheshire Rabbits Farms
- Weight at study initiation: 2.5-3.0 kg
- Housing: They were housed individually in cages with a grid floor, beneath which was a peat moss filled tray.
- Diet (e.g. ad libitum): The animals were fed on Spratt's Rabbit Diet, ad libitum.
- Water (e.g. ad libitum): Water was allowed ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (extremes of 16°C-23°C)
- Humidity (%): 65% (extremes of 60%-78%)

No additional data

Test system

Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

No additional data
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 male and 3 female
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: The eyes were examined for irritation using standard illumination.

No additional data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: One treated eye showed slight redness at 7 days.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
The test material elicited no corneal or iridial response at any stage of the test.
Slight redness of the conjunctivae was noted in 2/6 treated eyes at 1 h. One treated eye showed slight redness at 7 days. 5/6 treated eyes had returned to normal at 24 h.
Other effects:
Test material was evident as aggregations in the inner corner of the eye at 1 h in all treated eyes and in 1/6 treated eyes at 24 h.

Any other information on results incl. tables

 

Scores

Time after administration

Rabbit No. and Sex

7♂

8♀

9♂

10♀

11♂

12♀

1 hour

Cornea

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae redness

1

0

0

0

0

1

Conjunctivae chemosis

0

0

0

0

0

0

Conjunctivae discharge

0

0

0

0

0

0

24 hours

Cornea

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae redness

0

0

0

0

0

0

Conjunctivae chemosis

0

0

0

0

0

0

Conjunctivae discharge

0

0

0

0

0

0

48 hours

Cornea

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae redness

0

0

0

0

0

0

Conjunctivae chemosis

0

0

0

0

0

0

Conjunctivae discharge

0

0

0

0

0

0

72 hours

Cornea

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae redness

0

0

0

0

0

0

Conjunctivae chemosis

0

0

0

0

0

0

Conjunctivae discharge

0

0

0

0

0

0

7 days

Cornea

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae redness

0

1

0

0

0

0

Conjunctivae chemosis

0

0

0

0

0

0

Conjunctivae discharge

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is a mild irritant to eyes. However under the Regulatin (EC) No 1272/2008 it is not classified for eye irritation
Executive summary:

Under the Regulatin (EC) No 1272/2008, the test substance tested as HMX in water, is not classified for skin irritation. As per the table below the mean score for corneal opacity or iritis wasn't ≥ 1 and/or conjunctival redness or oedema (chemosis) wasn't ≥ 2

calculated between the time points: 24, 48 and 72 hours.

Animal no

Mean scores at 24, 48 and 72 hrs)

Cornea

Iris

Conjunctivae

redness

chemosis

discharge

33

0

0

0.33

0

0

34

0

0

0.17

0

0

35

0

0

0

0

0

36

0

0

0

0

0

37

0

0

0.17

0

0

38

0

0

0.33

0

0