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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 April to 25 May 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
Principles of method if other than guideline:
Draize, J. H. (1963) Federal Register, 28 (110). 6.6.1963 para. 191.12.

Kay, J. H. and Callandra, J. C. (1962) Interpretation of eye irritation tests. J. Soc. Cosmet. Chem., 13, 281-290.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentene
EC Number:
246-916-6
EC Name:
Pentene
Cas Number:
25377-72-4
Molecular formula:
C5H10
IUPAC Name:
pent-1-ene
Details on test material:
- Name of test material (as cited in study report): Pentene-1, N-amylene (as CAS No. 109-67-1)

- Physical state: Colourless liquid.

- Analytical purity: 94.4%

- Lot/batch No.: ST83/065

- Expiration date of the lot/batch: 1 October 1983.

- Stability under test conditions: Tested using infra-red spectra. The substance is judged to have been stable for the duration of the study. (Stabilities of formulations of the test substance) The stabilities of formulations of the test substance in corn oil or corn oil: Freund's Complete Adjuvant (1:1 v/v) were assessed by a panel of qualified chemists. These formulations were stable for at least one working day (7.5 h).

- Storage condition of test material: In the dark at ambient temperature.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
(eyes unwashed after the application of the substance), up to 7 days.
Observation period (in vivo):
See above.
Number of animals or in vitro replicates:
Three males and three females.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
629 female
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
633 female
Time point:
24/48/72 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
627 female
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #4
Remarks:
659 male
Time point:
24/48/72 h
Score:
0.17
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #5
Remarks:
657 male
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Remarks:
661 male
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
629 female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
633 female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
627 female
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
659 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
657 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
661 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
other: all animals (3 males and 3 females)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
other: all animals (3 males and 3 females)
Time point:
24/48/72 h
Score:
0
Max. score:
2
Other effects:
Not reported.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material, pentene-1, was practically non-irritating to rabbit eyes. On administration of the test material there was a severe
initial pain response.
Executive summary:

The test material, pentene-1, was practically non-irritating to rabbit eyes. On administration of the test material there was a severe

initial pain response.

The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).

The test was conducted following to the similar methodologies as OECD testguideline 405 (1981). There are no information available regarding the testing facility therefore a reliability of 2 is assigned.