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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:
10 March 2009 to 31 March 2009
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:
2009
Report Date:
2009

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)
Remarks:
Date of inspection: 19 August 2008; Date of signature: 04 March 2009

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification : H-CB sodium salt
Description : blue solid
Lot number : MB-2
Date received : 04 December 2008
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:
TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.60 kg
- Housing: The animal was housed in a suspended cage.
- Diet: Free access to food (supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study.
- Water: Free access to mains drinking water was allowed throughout the study.
- Acclimation period: 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):twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

IN-LIFE DATES: From: Day 0 To: Termination

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye left untreated and used as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (0.98 mg)

Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours for initial effects and then 7, 14 and 21 days for reversibility.
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not stated in report

SCORING SYSTEM: Draize Scale for Scoring Ocular Irritation; Classification according to EU Guidelines

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 #1
Remarks:
68301
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Blue colour staining to 1/4 of the cornea.
Irritation parameter:
cornea opacity score
Remarks:
Area of cornea involved
Basis:
animal #1
Remarks:
68301
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
68301
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects observed.
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Remarks:
68301
Time point:
other: mean of 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
not reversible
Remarks:
Blue coloured staning on the nictating membrane.
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
68301
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible

Any other information on results incl. tables

Ocular Reactions

Blue coloured staining of the fur was noted around the treated eye throughout the study.

Blue coloured staining of the nictitating membrane and cornea was noted in the treated eye one hour after treatment and at the 24, 48, 72-hour, 7 and 14‑day observations. Blue coloured staining of the nictitating membrane persisted in the treated eye at the 21‑day observation. The staining did not affect evaluation of ocular effects but was considered to be irreversible.

No corneal or iridial effects were noted during the study.

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

No ocular effects were noted at the 72-hour and subsequent observations.

Bodyweight

The animal showed expected gain in bodyweight during the study.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Due to irreversible colouration, the test material was considered to be irritant according to EU labelling regulations Commission Directive 2001/59/EC. It is reasonable to assume that the symbol “Xi”, the indication of danger “Irritant” and the highest risk phrase R 41 “RISK OF SERIOUS DAMAGE TO EYES” 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)
  • Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008

Result. A single application of the test material to the non-irrigated eye of one rabbit produced moderate conjunctival irritation. Irreversible colouration was noted in the treated eye.

Conclusion. The test material produced a total score of 8.0 and was classified as at least a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on one rabbit).

Due to irreversible colouration, the test material was considered to be irritant according to EU labelling regulations Commission Directive 2001/59/EC. It is reasonable to assume that the symbol “Xi”, the indication of danger “Irritant” and the highest risk phrase R 41 “RISK OF SERIOUS DAMAGE TO EYES” are therefore required.