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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 based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
23 Jan - 30 Jan 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable deviation (no analytical purity of the test item given).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted in 1987
Deviations:
yes
Remarks:
lack of details on test substance
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Isopropyl isodecanoate
EC Number:
269-023-3
EC Name:
Isopropyl isodecanoate
Cas Number:
68171-33-5
IUPAC Name:
68171-33-5
Details on test material:
- Name of test material (as cited in study report): trade name
- Physical state: very light yellow liquid
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ELEVAGE DES FEUILLETAS (40 - CAMPET LAMOLERE)
- Weight at study initiation: 2 ± 0.2 kg
- Housing: individually in stainless steel cages (61 x 46 x 34 cm) with a grid floor
- Diet: UAR 112, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 14
- 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):
72 hours
Reading time points: 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE: the test item was not washed out.

SCORING SYSTEM: Draize scoring system.

TOOL USED TO ASSESS SCORE: Electric lamp and ophthalmoscope were used for examination of the iris. For detection of cornea lesions, fluorescein sodium solution was used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: Reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: Reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: not applicable
Irritant / corrosive response data:
Slight conjunctival redness with slight chemosis and lacrimation graded 2 to 3 were seen in all 3 animals at reading time point 1 h. Slight redness persisted in 2 cases until reading time point 24 h.

Any other information on results incl. tables

Table 1: Evaluation of the eye reaction

Rabbit No.

Reading time

Conjunctiva

Iris

Cornea

Chemosis

Lacrimation

Redness

1

1 h

1

3

1

0

0

24 h

0

0

1

0

0

48 h

0

0

0

0

0

72 h

0

0

0

0

0

Mean1

0

0

0.33

0

0

2

1 h

1

3

1

0

0

24 h

0

0

1

0

0

48 h

0

0

0

0

0

72 h

0

0

0

0

0

Mean1

0

0

0.33

0

0

3

1 h

1

2

1

0

0

24 h

0

0

0

0

0

48 h

0

0

0

0

0

72 h

0

0

0

0

0

Mean1

0

0

0

0

0

 Mean1= Mean over 24, 48 and 72 hours

 

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