Cyclopentene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Reason / purpose for cross-reference:

read-across source

Principles of method if other than guideline:

BASF test:
ca. 1 ml of the undiluted test substance was applied to a 2.5 x 2.5 cm application site of two white Vienna rabbits for 20 h under occlusive conditions. The skin was shaved but intact. The two animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24, 48 hours as well as on day 5, 7 and at the end of the observation period on day 8. Findings were graded as described in OECD test guideline 404.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.99 and 2.54 kg
- Diet: ad libitum
- Water: ad libitum

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 1 ml

Duration of treatment / exposure:

20 hours

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 X 2.5 cm, shaved but intact skin

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing done


SCORING SYSTEM:
BASF scheme
Erythema:
(+) corresponds to Draize score 1
R+ corresponds to Draize score 2
R++ corresponds to Draize score 3
R+++ corresponds to Draize score 4
Edema
Ö(+) corresponds to Draize score 1
Ö+ vorresponds to Draize score 2
Ö++ corresponds to Draize score 3
Sack Ö+++ corresponds to Draize score 4
Sch+ slight scales
Sch++ rhagade-like scales

Readings were performed 24 hours, 48 hours 5, 7 and 8 days after the application of the test substance.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.75

Max. score:

4

Reversibility:

not fully reversible within: 8 days (only animal 1)

Remarks on result:

other: 72 hr time endpoint not measured

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: for animal 1 the 5 day score was considered as edema was not graded after 48 hours; slight scaling was observed after 7 and 8 days

	Animal 1		Animal 2		Mean
	Erythema	Ed.	Erythema	Edema	Ery.	Ed.
24 hours	1	2	2	2	1.5	2
48 hours	2	unknown	2	2	2	2
5 days	2	2	2	2	2	2
7 days	2	slight scaling	0	slight scaling	1	-
8 days	1	slight scaling	0	slight scaling	0.5	-
Mean 24 and 48 hours	1.5	-	2	2

 

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test material was applied for 20 hours under occlusive conditions. The result thus represents a worst case. As irritation was still observed at the end of the observation period in 50 % of the animals and slight scaling was observed in both animals, the substance is regared as skin irritant Cat. 2 as a worst case assumption although the 24/48 hour values alone would not warrant classification according to CLP.

Executive summary:

In this study, 1 mL of a test material, cyclohexene was applied to skin of two rabbits for 20 hours under occlusive conditions.

The mean erythema score obtained was 1.75 and the mean oedema score was 2, which were not reversible within the 8 -day observation period.

As irritation was still observed at the end of the observation period in 50 % of the animals and slight scaling was observed in both animals, the substance is regared as skin irritant Cat. 2 as a worst case assumption although the 24/48 hour values alone would not warrant classification according to CLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Principles of method if other than guideline:

BASF test:
ca. 1 ml of the undiluted test substance was applied to a 2.5 x 2.5 cm application site of two white Vienna rabbits for 20 h under occlusive conditions. The skin was shaved but intact. The two animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24, 48 hours as well as on day 5, 7 and at the end of the observation period on day 8. Findings were graded as described in OECD test guideline 404.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexene

EC Number:

203-807-8

EC Name:

Cyclohexene

Cas Number:

110-83-8

Molecular formula:

C6H10

IUPAC Name:

cyclohexene

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.99 and 2.54 kg
- Diet: ad libitum
- Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 1 ml

Duration of treatment / exposure:

20 hours

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 X 2.5 cm, shaved but intact skin

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing done


SCORING SYSTEM:
BASF scheme
Erythema:
(+) corresponds to Draize score 1
R+ corresponds to Draize score 2
R++ corresponds to Draize score 3
R+++ corresponds to Draize score 4
Edema
Ö(+) corresponds to Draize score 1
Ö+ vorresponds to Draize score 2
Ö++ corresponds to Draize score 3
Sack Ö+++ corresponds to Draize score 4
Sch+ slight scales
Sch++ rhagade-like scales

Readings were performed 24 hours, 48 hours 5, 7 and 8 days after the application of the test substance.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.75

Max. score:

4

Reversibility:

not fully reversible within: 8 days (only animal 1)

Remarks on result:

other: 72 hr time endpoint not measured

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: for animal 1 the 5 day score was considered as edema was not graded after 48 hours; slight scaling was observed after 7 and 8 days

Remarks:

72 hr time endpoint not measured

Any other information on results incl. tables

	Animal 1		Animal 2		Mean
	Erythema	Ed.	Erythema	Edema	Ery.	Ed.
24 hours	1	2	2	2	1.5	2
48 hours	2	unknown	2	2	2	2
5 days	2	2	2	2	2	2
7 days	2	slight scaling	0	slight scaling	1	-
8 days	1	slight scaling	0	slight scaling	0.5	-
Mean 24 and 48 hours	1.5	-	2	2

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test material was applied for 20 hours under occlusive conditions. The result thus represents a worst case. As irritation was still observed at the end of the observation period in 50 % of the animals and slight scaling was observed in both animals, the substance is regared as skin irritant Cat. 2 as a worst case assumption although the 24/48 hour values alone would not warrant classification according to CLP.

Executive summary:

In this study, 1 mL of a test material, cyclohexene was applied to skin of two rabbits for 20 hours under occlusive conditions.

The mean erythema score obtained was 1.75 and the mean oedema score was 2, which were not reversible within the 8 -day observation period.

As irritation was still observed at the end of the observation period in 50 % of the animals and slight scaling was observed in both animals, the substance is regared as skin irritant Cat. 2 as a worst case assumption although the 24/48 hour values alone would not warrant classification according to CLP.