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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in compliance with international guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Identification: 13F-SFA-Monomer
description: clear clourless liquid
Batch number: 061115
storage conditions: room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three New Zealand White rabbits were supplied by an accredited supplier. At the start of the study the animals were in the weight range of 2.0 to 3.5 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended cages. Free access to mains drinking water and food (Certified Rabbit Diet) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
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.
Duration of treatment / exposure:
72 h
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately I hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation from Draize J H (1977) “Dermal and Eye Toxicity Tests” In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
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 the six point scale shown in the field "attached background material"
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
other: animal #1, #2, #3
Time point:
other: 1 h
Score:
6
Max. score:
6
Reversibility:
fully reversible within: 48 h
Irritation parameter:
overall irritation score
Basis:
animal: #1, #2, #3
Time point:
other: 24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
overall irritation score
Basis:
animal: #1, #2, #3
Time point:
other: 48 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
animal: #1, #2, #3
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
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 conjunetivae = (A + B + C) x 2
Score for iris = D x 5
Seoreforcomea = (ExF)x5
Using the numerical data obtained a modified version of the system described by Kay J H and Calandra 3 C (1962), 3. Soc. Cosmet. Chem. 13, 28 1-289 (see Appendix 3) was used to classi& the ocular irritaney potential of the test material. This was achieved by adding together the scores for the cornea, iris and eonjunctivae 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 enabled classification of the eye irritancy potential of the test material.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information minimal irritant Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum group mean score of 6.0 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.However, according to the Official Journal of the European Union 1272/2008 (CLP) dated December 16th2008 the test item shall not be classified as eye irritating.