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other: GLP compliant, guideline study, available as unpublished report, minor restrictions reporting but otherwise adequate for assessment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 (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): E000144700
- Physical state: Clear, pale yellow to yellow liquid, gasoline-like naphtha odour
- Analytical purity: Not reported
- Lot/batch No.: Not reported
- Stability under test conditions: Stable
- Storage condition of test material: 50-80°F

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: Sterling Rabbitry, Wellsville, Utah, USA.
- 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 10 per 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:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 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: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.6
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: slight to severe effects in all 6 animals
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: very slight to moderate effects in all 6 animals

Any other information on results incl. tables

After 1, 24 and 48 hours, conjunctival redness and chemosis were present in all six rabbits, after 72 hours these conditions still persisted in five animals. Conjunctival discharge was present in one rabbit only at the 1 hour reading. There was no corneal or iridial involvement in any animal.

Table 1: Eye irritation scores

Time

Cornea

Iris

Conjunctiva

Redness

Chemosis

Animal number

91

95

101

104

105

106

91

95

101

104

105

106

91

95

101

104

105

106

91

95

101

104

105

106

after 1 hour

0

0

0

0

0

0

0

0

0

0

0

0

3

2

2

3

3

2

3

1

2

1

1

2

after 24 hours

0

0

0

0

0

0

0

0

0

0

0

0

3

1

2

2

2

2

2

1

2

1

1

2

after 48 hours

0

0

0

0

0

0

0

0

0

0

0

0

2

0

1

2

2

2

2

1

1

1

1

2

after 72 hours

0

0

0

0

0

0

0

0

0

0

0

0

2

0

1

2

1

2

2

0

1

1

1

2

mean scores 24-72h

0

0

1.6

1.3

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
E000144700 is not irritating to the rabbit eye.
Executive summary:

Eye irritation potential of E000144700 (CAS 68516-20-1) was determined in a group of six albino rabbits. 0.1 mL of neat test substance was instilled into 1 eye and responses were monitored for 72 hours. 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. E000144700 (CAS 68516-20-1) was not irritating to the rabbit eye and does not warrant classification under Dir 67/548/EEC or GHS CLP.