Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
8 November 1994 and 12 November 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
The work described was performed in compliance with the UK Principles of Good Laboratory Practice (The United Kingdom Compliance Programme. Department of Health 1989)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Rabbits were supplied by David Percival Ltd. Moston. Sandbach. Cheshire. UK.
- Age at study initiation: Twelve to twenty weeks old
- Weight at study initiation: Animals weighed 2.43 to 2.68kg and were approximately twelve to twenty weeks old.
- Housing:Animals were individually housed in suspended metal cages.
- Diet (e.g. ad libitum): Free access to mains drinking water and food (STANRAB SQC Rabbit Diet. Special Diets Services Ltd. Witham. Essex. UK) was allowed throughout the study.
- Water (e.g. ad libitum):Free access to mains drinking water and food (STANRAB SQC Rabbit Diet. Special Diets Services Ltd. Witham. Essex. UK) was allowed throughout the study.
- Acclimation period: Seven days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Animal room maintained a temperature of 17 to 19°C.
- Humidity (%): 56 to 65%
- Air changes (per hr): Rate of air exchange was approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light):Lighting controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used for control purposes.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1ml
- Concentration (if solution):No Data


VEHICLE
- Amount(s) applied (volume or weight with unit):Not applicable
- Concentration (if solution):Not applicable
- Lot/batch no. (if required): Not applicable
- Purity:Not applicable
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
9 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
In group 1 the animals were treated with the test material without washing.
In group 2 three rabbits were treated in a similar manner to the unwashed group, except that 30 seconds following introduction of the test material, the treated eye was gently irrigated with 100 ml of lukewarm tap water for one minute. The contralateral eye was similarly irrigated.
- Time after start of exposure:No Data


SCORING SYSTEM:

The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5

The scores for the cornea, iris and conjunctivae were totalled for each rabbit at each observation time. The group means of the total scores for each observation were then calculated.

The mean of the group mean scores at 24,48 and 72 hours was also determined. In addition, the number of rabbits showing a positive effect was recorded.

TOOL USED TO ASSESS SCORE:
Immediately before the start of the test, both eyes of the nine provisionally selected test rabbits were examined under ultra violet light after treatment with sodium fluorescin B.P. (Flourets: Smith and Nephew Pharmaceuticals Limited) for evidence of occular irritation or defect. Immediately before treatment, the rabbit eyes were again examined with the aid of light source from a standard opthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
other: Group 1
Time point:
other: 24 h
Score:
0
Reversibility:
not specified
Irritation parameter:
overall irritation score
Basis:
other: Group 2
Time point:
other: 24 h
Score:
0
Reversibility:
not specified
Irritant / corrosive response data:
Group 1:Applied as Supplied, Unwashed
Individual and group mean scores for occular irritation are given in Tables 1 and 2.
No corneal or iridial effects were noted during the study.
Conjunctival redness was noted in three treated eyes one hour after treatment.
No occular effects were noted 24 hours after treatment.

Group 2: Applied as Supplied, Washed 30 seconds after application.
Individual and group mean scores for occular irritation are given in Tables 4 and 5.

No occular effects were noted during the study.

Any other information on results incl. tables

Please see attachment 1 - Tables and Attachment 2- Appendices

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, Alkane 2, when applied as supplied and without irrigation from the eye, produced a mean 24 hour weighted Draize score of 0.0. No positive effects were noted during the study period.

The test material, Alkane 2, when applied as supplied and washed from the eye 30 seconds after treatment,produced a mean 24 hour weighted Draize score of 0.0. No positive effects were noted during the study period. The mean scores for each type of occular lesion required for EC labelling regulations are as follows:

Non-Irrigated Eye

Occular Lesion Mean Score
Corneal Opacity 0.0
Iridial lesion 0.0
Redness of conjunctivae 0.0
Chemosis of conjunctivae 0.0
Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit with or without subsequent irrigation.

The study was designed to comply with the requirements of the U.S. Environmental Protection agency (EPA) Guidelines, The OECD Guidelines for testing of chemicals No.405 " Acute eye irritation/Corrosion" (adopted 24 February 1987) and Method B5 of commission Directive 92/69/EEC ( which constitutes Annex V opf council Directive 67/548/EEC).

A single instillation of the test material to the non-irrigated eye of six rabbits produced a mean 24 hour weighted Draize score od 0.0.

Conjuntival redness was noted in three treated eyes one hour after treatment. No occular effects were noted 24 hours after treatment. No positive effects were noted.

A single instillation of the test material to the eye of another group of three rabbits, with irrigation of the eyes 30 seconds after treatment, produced a mean 24 -hour weighted Draize score 0.0.

No occular effects were noted during the study. No positive effects were noted.

The mean scores for each type of occular lesion required for EC labelling regulations are as follows:

Non Irrigated Eye

Occular Lesion Mean Score

Corneal Opacity 0.0

Iridial lesion 0.0

Redness of conjunctivae 0.0

Chemosis of conjunctivae 0.0