Cyclopentene

Endpoint summary

Description of key information

Skin irritaiton:

The skin irriation study performed with cyclopentene (Smyth 1962) is regarded to be not sufficient for assessment (open application although the substance has a high fugacity, use of a 10 -grade scaling system which is not comparable to the Draize scores, less details on results). However, the test substance caused irritating effects on the skin.

Cyclohexene, which is a structurally related substance, also caused irritating effects on the skin (BASF AG 1973) yielding to a classification with R38/GHS skin irritation Cat.2 (GHS Cat.2 is regarded to be warranted due to the scaling observed after 7 and 8 days)

In analogy, cyclopentene is classified with R38/GHS skin irritation Cat. 2

Eye irrtiation:

The eye irriation study performed with cyclopentene (Smyth 1962) is regarded to be not sufficient for assessment (use of a 10 -grade scaling system which is not comparable to the Draize scores, less details on results). However the test substance caused eye irritating effects.

Cyclohexene, which is a structurally related substance, also caused only slight eye irritating effects (BASF AG 1973) which do not warrant a classification.

In analogy, cyclopentene is regarded to have no distinct eye irritating properties.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Study period:

1969

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Not sufficient for assessment;

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method described in the publication of Smyth et al. (1962)
Application of undiluted sample
Primary skin irritation is recorded in a 10-grade ordinal series and is based upon the severest reaction that develops on the clipped skin of each of the animals. Grade 1:no irritation; Grade 2: least visible capillary injection from the undiluted chemical; Grade 6: necrosis from the undiluted chemical; Grade 10 necrosis from 0.01% solution.
Restrictions/deviations compared to an OECD 404 guideline study:
no post-exposure observation time;
Irritation was recorded in an 10-grade scale which is not comparable to the Draize score;
no description of the test material

GLP compliance:

no

Specific details on test material used for the study:

Not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Not specified

Type of coverage:

open

Preparation of test site:

other: clipped

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.01 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

24 hour(s)

Observation period:

none

Number of animals:

5

Details on study design:

SCORING SYSTEM:
10 grades:
Grade 1:no irritation; Grade 2: least visible capillary injection from the undiluted chemical; Grade 6: necrosis from the undiluted chemical; Grade 10 necrosis from 0.01% solution.

Irritation parameter:

other: 10 grade ordinal series

Basis:

mean

Time point:

other: within 24 hours

Score:

5

Max. score:

10

Reversibility:

no data

The test substance caused irritating reactions. However, the details given are not sufficient for an definitive assessment and raise some question on the suitability of the test system. Furthermore, an open application seems unsuitable regarding the fugacity of the TS

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Remarks:

according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008

Conclusions:

Within 24 -hours, a mean score of 5 on the 10 grade ordinal series irritation parameter was obtained for the test substance, cyclopentene. The test substance caused irritating reactions in rabbits. However, the details given are not sufficient for an definitive assessment and raise some question on the suitability of the test system. Furthermore, an open application seems unsuitable regarding the fugacity of the TS

Executive summary:

The study was an investigation into the skin irritation potential of the test substance, cyclopentene, in rabbits. Within 24 -hours, a mean score of 5 on the 10 grade ordinal series was obtained. The test substance caused irritating reactions. However, the details given are not sufficient for an definitive assessment and raise some question on the suitability of the test system. Furthermore, an open application seems unsuitable regarding the fugacity of the TS

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Study period:

1969

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Irritation was recorded in an 10-grade scale which is not comparable to the Draize score. No information about volumes and concentrations administered. The results of the skin irritation test, that was performed in parallel, raises some questions on the substance identity and reliability.

Principles of method if other than guideline:

Method is described in the publication of Smyth et al. (1962)
Eye injury is recorded in a 10-grade ordinal series and is based upon the degree of corneal necrosis: Grade 1: very small area of necrosis resulting from 0.5 ml of undiluted chemical; Grade 5: severe burn from 0.005 ml; Grade 10: severe burn from 0.5 ml of a 1% solution.

GLP compliance:

no

Specific details on test material used for the study:

Not specified

Species:

rabbit

Details on test animals or tissues and environmental conditions:

Not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): various (no further details available)
- Concentration (if solution): various (no further details available)

Duration of treatment / exposure:

Not specified

Observation period (in vivo):

Not specified

Number of animals or in vitro replicates:

Not specified

Details on study design:

Eye injury is recorded in a 10-grade ordinal series and is based upon the degree of corneal necrosis: Grade 1: very small area of necrosis resulting from 0.5 ml of undiluted chemical; Grade 5: severe burn from 0.005 ml; Grade 10: severe burn from 0.5 ml of a 1% solution.

Irritation parameter:

other: 10-grade ordinal series

Basis:

mean

Time point:

other: no data

Score:

5

Max. score:

10

Reversibility:

not specified

Interpretation of results:

GHS criteria not met

Conclusions:

The eye irritation potential of the test substance, cyclopentene, was investigated in rabbits. Cyclopentene gave a corneal injury score in rabbits of 5 out of maximum of 10 in the 10 -grade ordinal series.

Executive summary:

This study was an investigation into the eye irritation potential of the test substance, cyclopentene, in rabbits. The degree of eye injury was recorded in a 10 -grade ordinal series and based on the degree of corneal necrosis that results from the instillation of various volumes and concentrations of the chemical. Cyclopentene gave a corneal injury score in rabbits of 5 out of maximum of 10 in the 10 -grade ordinal series.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Cyclopentene is classified as skin irritant cat 2 under EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. Based on the available in vivo studies, cyclopentene was considered to be minimally irritating to rabbit eyes and would not meet the criteria to be classified as an eye irritant.