Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19th January 2010 to 4th February 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of GLP inspection: 15th September 2009 Date of Signature on GLP certificate: 26th November 2009

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification :DVS005u (aka Weston 705)
Description : clear colourless viscous liquid
Batch number : MW9F23A901
Date received : 05 November 2009
Expiry date : 15 June 2010
Storage conditions :approximately 4°C in the dark under nitrogen

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Hillcrest, Belton, Loughborough, UK.
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.26 to 2.92 kg
- Housing: The animals were individually housed in suspended cages.
- Diet: ad libitum - 2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK
- Water: ad libitum - mains drinking water
- Acclimation period: acclimatisation period of at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

IN-LIFE DATES: From: Day of dosing (Day 0) To: Day of sacrifice - Day 7 :

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye remained untreated and was used for control purposes.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
One animal treated initially, then after consideration of the first animal's ocular response, two additional animals were treated.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated in report
- Time after start of exposure: not stated in report

SCORING SYSTEM: Modified version of the Kay and Calandra system.
CLASSIFICATION: EU

TOOL USED TO ASSESS SCORE: standard opthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Degree of opacity
Basis:
animal: 68822 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Remarks:
Degree of opacity
Basis:
animal: 68842 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Remarks:
Degree of opacity
Basis:
animal: 68843 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 68822 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 68842 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 38843 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0
Max. score:
2
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 68822 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 24hours
Remarks on result:
other: Score of 2 observed at 1 hour
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 68842 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 2 observed at 1 hour
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 68843 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 2 observed at 1 hour
Irritation parameter:
chemosis score
Basis:
animal: 68822 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 2 observed at 1 hour
Irritation parameter:
chemosis score
Basis:
animal: 68842 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 2 observed at 1 hour
Irritation parameter:
chemosis score
Basis:
animal: 68843 Male
Time point:
other: Mean of 24, 48 and 72 hrs
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 2 observed at 1 hour
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study.

Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted at the 24 and 48-hour observations. Minimal conjunctival irritation was noted in one treated eye at the 72-hour observation.

Two treated eyes appeared normal at the 72 hour observation and the remaining treated eye appeared normal at the 7 day observation.
Other effects:
All animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

REET study:

Following assessment of the data for all endpoints the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrases are therefore required.
Executive summary:

Introduction. The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

§        OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)

§        Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008

Initial considerations. In the absence of available information indicating that the test material had the potential to produce severe effects in a rabbit eye, a Rabbit Enucleated Eye Test (REET) was performed prior to the in vivo test. The results are given in Appendix 4 and indicated that the test material was unlikely to cause severe ocular irritancy.

Result. A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Two treated eyes appeared normal at the 72-hour observation and the remaining treated eye appeared normal at the 7-day observation.

Conclusion. The test material produced a maximum group mean score of 12.0 and was classified as a mild irritant (Class 4 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 irritant according to EU labelling regulations Commission Directive 2001/59/EC.