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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report, minor reporting restrictions, otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): E000044012
- Clear, pale yellow to yellow-coloured liquid; disagreeable odour
- Specific gravity: AP = 0.87 - 0.91 (H2O = 1 at 39.2°F)
- Flash point: AP = 75°F
- Analytical purity: no data
- Test material data on file with the study sponsor

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Sterling Rabbitry, Wellsville, Utah, USA
- Sex: 4 males and 2 females
- Age at study initiation: young adult
- Weight at study initiation: 2.0 - 4.0 kg
- Housing: Individually, in stainless steel, wire mesh bottom cages
- Diet: Agway rabbit feed ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 61 - 70°F
- Humidity: 40 - 60%
- Air changes: At least 10per hr
- Photoperiod: 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 20 February 1990 To: 23 February 1990

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Single dose
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
The test article was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test article was dropped. The upper and lower lids were gently held together for approximately one second to prevent loss of test material.
Animal body weights were taken within 48 hours of receipt and prior to dosing. All animals were sacrificed following the 72 hour scoring period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no corneal effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: no iridial effects
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: No cornea effects
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
other: No iridial effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: minimal to marked effects in all 6 rabbits
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: very slight to slight effects in all 6 rabbits

Any other information on results incl. tables

Eye irritation scores according to the Draize scheme

Time

Conjunctivae, redness

Conjunctivae, chemosis

Animal number

81

86

93

100

102

103

81

86

93

100

102

103

after 1 hour

3

2

3

3

3

3

3

1

3

3

2

2

after 24 hours

3

2

3

3

3

1

2

1

2

2

1

1

after 48 hours

2

2

2

2

3

1

2

1

2

2

1

1

after 72 hours

2

2

2

2

3

1

2

1

2

2

1

1

mean scores 24-72h

2.3

2.0

2.3

2.3

3.0

1.0

2.0

1.0

2.0

2.0

1.0

1.0

Discharge seen in all 6 animals after 1 hour and in 2 animals after 24 hours

Applicant's summary and conclusion

Interpretation of results:
other: Irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
E000044012 is irritating to the rabbit eye.
Executive summary:

Eye irritation potential of E000044012 (CAS 68478-10-4) was determined in a group of six albino rabbits.

There was no evidence of damage to the cornea or iris throughout the study. Conjunctival redness and chemosis was seen from 1 hour to 72 hours after application.

It can be concluded that E000044102 (CAS 68478-10-4) is not irritating to the rabbit eye. Under GHS/CLP classification, it triggers "Causes serious eye irritation" Cat 2A, H319.