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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Dec 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance Hexanoic acid, 2-ethyl-, 2,2-bis [ [(2-ethyl-1-oxohexyl)oxy] methyl] -1,3-propanediyl ester. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: CARON-St Germain-Laxis, 77950 Maincy, France
- Sex: male
- Weight at study initiation: about 2.5 - 3 kg
- Housing: in individual polysterene cages of standardized dimensions with perforated floor
- Diet: Pietrement C15, ad libitum
- Water: tap water provided in sterilized makrolon bottles equipped with stainless steel pipettes, ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 50 - 80
- Air changes (per hr): 3000 m³
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
single application without washing
Observation period (in vivo):
7 days
Reading time points: 4, 24, 48, 72 h and 7 days
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM:
Draize scoring system according to EEC guideline 67/548

TOOL USED TO ASSESS SCORE: 2% aequous solution of sodium fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The observed lesions in all 3 animals were benign, exclusively conjunctival and of low intensity. They are fully reversible by day 2.

Any other information on results incl. tables

Table 1: Individual scores of the animals.

Reading time point

Animal No.

Cornea

Iris

Conjunctiva

Area of opacity

Opacity

Redness

Chemosis

Lacrimation

4 h

1100

0

0

0

2

0

0

1101

0

0

0

2

0

0

1102

0

0

0

2

0

0

24 h

1100

0

0

0

1

0

0

1101

0

0

0

1

0

0

1102

0

0

0

1

0

0

48 h

1100

0

0

0

0

0

0

1101

0

0

0

0

0

0

1102

0

0

0

0

0

0

72 h

1100

0

0

0

0

0

0

1101

0

0

0

0

0

0

1102

0

0

0

0

0

0

7 days

1100

0

0

0

0

0

0

1101

0

0

0

0

0

0

1102

0

0

0

0

0

0

mean 24-48-72 h

1100

0.0

0.0

0.0

0.3

0

0.0

1101

0.0

0.0

0.0

0.3

0

0.0

1102

0.0

0.0

0.0

0.3

0

0.0

mean

0.0

0.0

0.0

0.3

0

0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified

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