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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:
25 July 2005 to 04 August 2005
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
3,3'-[ethylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, compound with 2,2',2''-nitrilotriethanol (1:6)
Cas Number:
75701-36-9
IUPAC Name:
3,3'-[ethylenebis[(3-sulpho-p-phenylene)azo]]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonic] acid, compound with 2,2',2''-nitrilotriethanol (1:6)
Test material form:
other: granular solid
Details on test material:
- Name of test material (as cited in study report): Cartasol Blue PE3514 dried
- Physical state: dark blue granular solid (ground to powder for application)
- pH of 10% aqueous solution: 7.5

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually
- Diet: Certified Rabbit Diet (Code 5322) from BCM IPS Ltd, London UK ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): ≥15/hr
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (96 mg)
Duration of treatment / exposure:
single instillation (eyelids were hold for 1 second)
Observation period (in vivo):
72 hours (observations at 1, 24, 48 and 72 hours after instillation)
Number of animals or in vitro replicates:
3 males
Details on study design:
First one animal was treated. After consideration of the ocular responses of this animal 2 additional animals were treated

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Other effects:
Black staining of the fur arround the treated eye was observed at all timepoints

Any other information on results incl. tables

Animal no 1       2       3      
Time 1 24 48 72 1 24 48 72 1 24 48 72
cornea  0 0 0 0 0 0 0 0 0 0 0 0
iris 0 0 0 0 0 0 0 0 0 0 0 0
conjunctivae                        
redness 1 0 0 0 1 0 0 0 1 0 0 0
chemosis 0 0 0 0 0 0 0 0 0 0 0 0
discharge 0 0 0 0 0 0 0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is not irritating to the eyes
Executive summary:

Three rabbits received 96 mg of the substance in the eye. Very slight irritation was seen 1 hour after installation. At the other observations (until 72 hours after instillation) no signs of irritation were found. The substance is not irritating to the eyes.

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