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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

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

Constituent 1
Chemical structure
Reference substance name:
2-butyloctanoic acid
EC Number:
248-570-1
EC Name:
2-butyloctanoic acid
Cas Number:
27610-92-0
Molecular formula:
C12H24O2
IUPAC Name:
2-butyloctanoic acid
Test material form:
liquid
Details on test material:
- Name of test material: 2-butyl octanoic acid
- Molecular formula: C12H24O2
- Molecular weight: 200.32 g/mole
- Smiles notation: O=C(O)C(CCCCCC)CCCC

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Strain: New Zealand White
- Sex: female
- Source: Charles River Italia S. p. A. (Como) (supplier), P.O.A.D.A. Mandello Lario (CO) (breeder), Italy
- Age: 9 to 11 weeks
- Weight at study initiation: 1.8 - 2.3 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated left eye
Amount / concentration applied:
- Amount of substance instilled: 0.1 ml
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: The test substance was applied undiluted.
- Amount of substance instilled: 0.1 ml
- Vehicle: none
- Postexposure period: 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: Ocular reactions were assessed. After 24 h exposure the eyes were examined additionally after instillation of Fluorescein and irrigation with 20 ml 0.9% sodium chloride solution using UV light.
- Scoring system: according to OECD 405
- Observation period: Ocular reactions were recorded 1, 24, 48 and 72 h after application.
- Tool used to assess score: not mentioned

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Well defined conjunctival redness, chemosis and ocular discharge in all three animals one hour after application which remained in one animal at the 24 hours examination. In the remaining two animals slight redness, chemosis and discharge were oserved at the 24 hour reading. At the 48 hour examination only slight conjunctival redness was observed in two animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results of this study indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect in the eye. However, the observed reaction was not sufficiently severe to require classification of the test item.
Executive summary:

The results of this study indicate that the test item, 2-butyloctanoic acid, has a slight irritant effect in the eye. However, the observed reaction was not sufficiently severe to require classification of the test item.