Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study test phase 2005-10-24 to 2005-11-03. Report completed and signed off 2005-12-21.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: FSM-003B
(FSM-003B is a synonym of S196439)
Nature of substance: powder
Batch number: CE-501-2
Date received: 23 August 2005

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg

- Housing: Individually housed in suspended cages
- Diet & Water: Free access to mains drinking water and food (certified rabbit diet).
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 changes per h
- Photoperiod (hrs dark / hrs light): 12h continuous light (06:00 to 18:00) and 12h darkness

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A volume of 0.1ml of test material, which was found to weigh approx. 41 mg.
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
Assessment of ocular damage/irritation was made approx. 1h and 24, 48 & 72h following treatment.
Number of animals or in vitro replicates:
3
Details on study design:
Immediately before the start of the test, both eyes of the provisionally selected rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.Initially a single rabbit was treated. A volume of 0.1 ml of 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 treatment to prevent loss of the test material and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material an assessment of the initial pain reaction was made according to a six point scale.

After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. In order to minimise pain on application of the test material one drop of local anaesthetic (Amethocaine hydrochloride 0.5%) was instilled into both eyes of the final animal 1 to 2 minutes before treatment.

Assessment of ocular damage/irritation was made approx. 1h, 24, 48 & 72h following treatment, according to the numerical evaluation given in appendix 2 (Draize JH, 1977, 'Dermal and Eye Toxicity Tests' In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC).

Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard opthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: (redness)
Basis:
animal: 88 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24h
Irritation parameter:
other: (redness)
Basis:
animal: 15 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24h
Irritation parameter:
other: (redness)
Basis:
animal: 16 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal: 88 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal: 15 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal: 16 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
cornea opacity score
Basis:
animal: 88 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
cornea opacity score
Basis:
animal: 15 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
cornea opacity score
Basis:
animal: 16 male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
iris score
Basis:
animal: 88 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24h
Irritation parameter:
iris score
Basis:
animal: 15 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24h
Irritation parameter:
iris score
Basis:
animal: 16 Male
Time point:
other: highest score at 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24h
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 24h.
Other effects:
Black staining of the fur was noted around all treated eyes throughout the study.

Minimal conjunctival irritation was noted at the 1 hour observation period. All effects were fully reversible at the 24-hour observation period.

Any other information on results incl. tables

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

Using the numerical data obtained a modified version of the system described by Kay and Calandra was used to classify the ocular irritancy potential of the test material. This was acheived 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 (the maximum group mean score) together with the persistence of the reactions enables classification of the eye irritancy potential of the test material.

Where evidence or irreversible ocular damage is noted, the test material will be classified as corrosive to the eye. The results were evaluated according to EU labelling regulations Commission Directive 2001/59/EC and Regulation (EC) No. 1272/2008 for classification and labelling of dangerous substances.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum group mean score of 4.0 and was classified as a 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 substance is not an eye irritant according to EU labelling regulations Commission Directive 2001/59/EC and Regulation (EC) No. 1272/2008.
Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test substance to the eye of the NewZealand white rabbit. The method was designed to be compatible with the following:

OECD Guidelines for the Testing of Chemicals No. 405 'Acute Eye Irritation/Corrosion (adopted 24 February 1987)

Method B5 Acute Toxicity (Eye Irritation) of Commision Directive 92/69/EEC.

Result and Conclusion

The test material produced a maximum group mean score of 4.0 and was classified as a 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 meet the criteria for classification as an eye irritant according to EU labelling regulations Commission Directive 2001/59/EC and Regulation (EC) No. 1272/2008.