Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 December 2014 to 06 May 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
Details on test material:
- Physical state: Dark yellow viscous liquid
- Analytical purity: 100 %
- Expiration date of the lot/batch: 12 June 2016
- 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 rabbits (Hsdlf:NZW) were supplied by Harlan Laboratories UK Ltd, Leicestershire, UK
- At the start of the study the animals weighed 2.56 kg or 2.74 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.
- Animals were individually housed in suspended metal cages.
- Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd, 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 °C to 23 °C and 30 % to 70 % respectively.
- The rate of air exchange was at least 15 changes per hour.
- Lighting was controlled by a time switch to give 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.
- 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:
0.1 mL
Duration of treatment / exposure:
72 hours
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
Remarks:
opacity
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 74921 (male)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: 74921 (male)
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 74921 (male)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score
Time point:
other: 24, 48 and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 74921 (male)
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 74944 (male)
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: 74944 (male)
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 74944 (male)
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score
Time point:
other: 24, 48 and 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 74944 (male)
Irritant / corrosive response data:
- Individual and group mean scores for ocular irritation are given in Table 1 and Table 2 (attached).

Any other information on results incl. tables

MEASUREMENT OF pH

- Aqueous preparation of the test item (10 % w/w): pH 8.62 immediately; pH 8.31 after 10 minutes.

OCULAR REACTIONS

- No corneal or iridial effects were noted during the study.

- Moderate conjunctival irritation was noted in both treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24 and 48 hour observations.

- Both treated eyes appeared normal at the 72 hour observation.

BODY WEIGHT

- Individual body weights and body weight change 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.

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 11.0 and was considered to be a mild irritant to the rabbit eye according to a modified Kay and Calandra system (Class 4 on a 1 to 8 scale). However, the test material is not classified under the terms of Regulation (EC) No 1272/2008.
Executive summary:

GUIDELINE

The study was performed in accordance with OECD Guideline for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 02 October 2013) and 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 moderate conjunctival irritation. Both treated eyes appeared normal at the 72 hour observation.

CONCLUSION

The test item produced a maximum group mean score of 11.0 and was considered to be a mild irritant to the rabbit eye according to a modified Kay and Calandra system (Class 4 on a 1 to 8 scale). However, the test material is not classified under the terms of Regulation (EC) No 1272/2008.