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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
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted under OECD guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
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:
Sponsors identification: SR-720
Date received: 15 January 1997
Description: White powder
Storage conditions: Ambient temperature (<25 °C), stored under artificial light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three rabbits were supplied by David Percival Ltd, Moston, Sandbach, Cheshire UK.
Weight at the start of the experiment: 3.28-3.49 kg; 12-16 weeks old.
After minimum acclimatisation of 5 days each animal was given a number.
The animals were housed individually in suspended metal cages, with free access to drinking water and food.
The animal room was maintained at a temperature of 17-19°C and relative humidity of 49-640%.
The air exchange was approx. 15 changes per hr and the lighting was controlled by a time switch to give 12 hr continous light and 12 hr darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used as control
Amount / concentration applied:
98 mg per 0.1 ml
Duration of treatment / exposure:
The test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of material and then released. Immediately after administration of the test material an assessment of the initial pain reaction was made.
In orded to minimise pain on application of the test materail, one drop of local anasthetic was instilled into both eyes of all animals 1-2 minutes before treatment.
Observation period (in vivo):
Assessment of ocular damage/irritation was made approx. 1, 24, 48 and 72 hr following treatment.
Number of animals or in vitro replicates:
Three animals
Details on study design:
The numerical values corresponding to each animal, tissue and observation time was 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 letter E (degree of opacity) and F (area of opacity). 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
Using the numerical data obtained a modified version of the system described by Kay JH and Calandra JC (1962) j. Soc. Cosmet. Chem.
was used to classify the ocular irritancy potential of the test material. This was achived by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means together with the persistence of the reactions enabled classification of the eye irritancy potential of the test material.
If any rabbit shows irrevesrsible ocular damage the test material will be classified as corrosive to the eye.

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72
Score:
4.7
Reversibility:
not specified
Irritant / corrosive response data:
Minimal conjunctival irritation was noted in all treated eyes one hr after treatment and in one treated eye at 24 hr observations.
Treated eyes appeared normal at the 24 or 48 hr observations
Other effects:
No corneal or iridial effects were noted during the study.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Class 3 on a 1-8 scale Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum group mean score of 4.7 and was classified as MINIMAL IRRITANT (CLASS 3 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrase are therefore required.
Executive summary:

Acute eye irritation test was conducted in New Zealand White rabbits using OECD guidelines 405 and method B5 of the commission Directive 92/69/EEC.

A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. Treated eyes appeared normal at the 24 or 48 hr observations.

The test material produced a maximum group mean score of 4.7 and was classified as MINIMAL IRRITANT (CLASS 3 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrase are therefore required.