Registration Dossier

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 January 1995 to 24 January 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to recent EU and OECD test guidance. GLP is assumed, given the references and QA procedures, although is not specifically mentioned.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

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
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes
Remarks:
GLP is assumed, given the references and QA procedures, although is not specifically mentioned.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Reactive Blue FC 75311

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd
- Age at study initiation: Adult
- Weight at study initiation: Average weight 3.8 kg
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Standard diet, approx 100-120g per animal/day; once per day in the morning
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50 - 70
- Air changes (per hr): 12 -15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours, artifical illumination from 6am to 6pm

Test system

Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx 67mg (equivalent to 100 ul test substance)

Duration of treatment / exposure:
24 hours exposure
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Normal saline
- Time after start of exposure: 24 hoours

SCORING SYSTEM: DRAIZE

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: overall at 24, 48 72 hours
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: All animals showed mild effects up to 72 hours. No effects were noted at the end of the exposure period.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 hours.
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72
Remarks on result:
other: All animals showed mild effects up to 72 hours. No effects were noted at the end of the exposure period.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritant / corrosive response data:
Exposure of the test substance to the eye resulted in all three animals in transient slight conjunctival redness and discharge, and in one animal a very slight oedema was observed too (1 hour after the application). These signs of irritation had subsided in all animals by 72 hours. Cornea and iris showed no lesions or other signs of irritation. No ocular lesions and other signs of toxicity were not observed. This evidence indicates that the product may be considered as 'not irritating to the eye'.
Other effects:
Some discolouration occured in conjunctiva of all animals but not sufficient to affect the readings of reactions. Conjunctival swelling was noted in one animal and discharge from the eyes of all animals at the 1 hour reading. These were not noted in remaining assessments.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance is not irritating to the eye
Executive summary:

Study conducted to recent EU test guidance 92/69/EEC B5 & OECD 405.

The substance was found not irritating to the eye.