Registration Dossier

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2nd April 2007 to 21st May 2007
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 relevant results.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
Date of inspection: 30th August 2005 Date of signature: 21st November 2005

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification :C-C1
Description : dark blue powder
Batch number : MB-1
Date received : 05 March 2007
Storage conditions :room temperature in the dark over silica gel

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: supplied by an accredited supplier
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended cages
- Diet : ad libitum access to Certified Rabbit Diet
- Water: ad libitum access to 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): 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 0 To: Day 4

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): 97 mg
- Concentration (if solution): not applicable

VEHICLE
- Not applicable
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not conducted
- Time after start of exposure: not applicable

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Degree of opacity
Basis:
animal: 66092 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed.
Irritation parameter:
cornea opacity score
Remarks:
Degree of opacity
Basis:
animal: 656245 Male
Time point:
other: Mean of 24, 28 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Remarks:
Degree of opacity
Basis:
animal: 656259 Male
Time point:
other: Mea of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal: 66092 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: 656245 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: 656259 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 66092 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 656245 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 656259 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: 66092 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal: 656245 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal: 656259 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
Blue coloured staining, covering the lower half of the cornea, was noted in two treated eyes at the 24, 48, 72-hour and 7-day observations and in one treated eye at the 14-day observation. The area of staining reduced to a quarter of the cornea in one treated eye at the 21-day observation. The staining did not effect evaluation of the cornea.

Blue coloured staining of the nictitating membrane and lower conjunctival membrane was noted in two treated eyes one hour after treatment and in all treated eyes at the 24, 48, 72-hour, 7 and 14-day observations with pale blue coloured staining of the nictitating membrane and lower conjunctival membrane at the 21-day observation. The staining did not effect evaluation of the occular effects.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material causes irreversible colouration of the cornea and the conjunctival membranes, which is classed as a severe ocular lesion, therefore, according to the Dangerous Substances Directive (DSD), the substance should be classified as R41 "Risk of Serious Damage to Eyes".
The substance is classified as Category 1, Causes serious eye damge, according to Regulation (EC) No. 1272/2008 (CLP).
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)

§        Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC

Result. A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Iridial inflammation was also noted in one treated eye. No ocular effects were noted at the 72-hour observation and at all subsequent observations.

Conclusion. The test material causes irreversible colouration of the cornea and the conjunctival membranes, which is classed as a severe ocular lesion, therefore, according to the DSD, the substance should be classified as R41 "Risk of Serious Damage to Eyes".

The substance is classified as Category 1, Causes serious eye damge, according to Regulation (EC) No. 1272/2008 (CLP).