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other: GLP compliant, guideline study, available as unpublished report, minor restrictions reporting but otherwise adequate for assessment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:
according 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: Fresh certified Agway rabbit feed ad libitum
- Water: Fresh potable water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 61-71°F
- Humidity: 40-60%
- Air changes: At least 10 per hr
- Photoperiod: 12hrs dark / 12hrs light

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

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
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Based on the Draize scale

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
Remarks on result:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.6
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: effects in all 6 rabbits 1, 24 and 48 hours, in 5 rabbits at 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: effects in all 6 rabbits 1, 24 and 48 hours, in 5 rabbits at 72 hours

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. 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. Mean scores over 24, 48 and 72 hours were: cornea 0, iris 0, conjunctival redness 1.6, chemosis 1.3.

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.