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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:
07 September - 17 September 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

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)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: waxy solid
Details on test material:
- Physical state: brown waxy solid
- Analytical purity:100%
- Expiration date of the lot/batch: 13 July 2017
- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
ANIMALS AND ANIMAL HUSBANDRY
- Two New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Envigo RMS (UK) Ltd, Leicestershire, UK.
- At the start of the study the animals weighed 3.33 or 3.36 kg and were 12 to 20 weeks old.
- After an acclimatisation period of at least 5 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 (2930C Teklad Global Rabitt diet supplied by Envigo RMS (UK), Oxon, UK) 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.
- Temperature and relative humidity were set to achieve limits of 17 to 23 °C and 30 to 70 % respectively.
- Rate of air exchange was at least 15 changes per hour.
- Lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
- The animals were provided with environmental enrichment items, which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1mL of test item
Duration of treatment / exposure:
Single application
Observation period (in vivo):
72-hours
Number of animals or in vitro replicates:
Two
Details on study design:
TEST ITEM FORMULATION AND EXPERIMENTAL PREPARATION
- The test item was used as supplied.
- Absorption of the test material was not determined.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 & 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: #75192
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 & 72h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: #75192
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 & 72h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: #75192
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48, 72h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: #75192
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48 &72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: #75205
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 & 72h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: #75205
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 24, 48 & 72h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: #75205
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean scores
Time point:
other: 24, 48, 72h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: #75205
Irritant / corrosive response data:
- Individual and group mean scores for occular irritation are given in Table 1 and Table 2 (attached).
- No corneal effects were noted during the study.
- Iridial inflammation was noted in one treated eyes 1 hour after application of the test item.
- Moderate conjunctival irritation was noted in both treated eyes at 1 hour after application of the test item with minimal conjunctival irritation noted at the 24 & 48 hour observation.
- Both treated eyes appeared normal at the 72-hour observation.
Other effects:
BODY WEIGHT
- Individual body weights are given in Table 3 (attached).
- one animal showed body weight loss and the other animal showed expected gain in body weight during the study

Any other information on results incl. tables

MEASUREMENT OF pH

- Test item undiluted as supplied.

- Aqueous preparation of test item (10 % w/w): pH 5.8 immediately; pH 6.07 after 10 minutes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item produced a maximum group mean score of 13.5 and was considered to be a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra system. However, the test material is not classified under the terms of Regulation (EC) No 1272/2008.
Executive summary:

GUIDELINE

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit using a procedure designed to be compatible with OECD Guideline for the Testing of Chemicals No 405 "Acute Eye Irritation/Corrosion" (adopted 02 October 2012) and EU Method B.5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No 440/2008.

RESULTS

A single application of the test item to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. Both eyes appeared normal at the 72 hour observation.

CONCLUSION

The test item produced a maximum group mean score of 13.5 and was considered to be a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra system. However, the test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for two animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for corneal opacity, iritis, conjunctival redness and chemosis.