Cyclopentanol, 2-pentyl-, (1R,2S)-rel-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

From June 12 to June 26, 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP study conducted according to OECD test Guideline No. 404. The study was fully reliable (Klimisch score = 1), however the reliability score was lowered to 2 which is the maximum score for read-across. The supporting substance is considered adequate for read-across purpose (see IUCLID section 13 for additional justification). Environmental conditions were not reported but assumed to be adequate because it is a GLP study.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

some details missing on test animals and environmental conditions, but assumed to be adequate because it is a GLP study.

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-pentylcyclopentan-1-ol

EC Number:

283-187-3

EC Name:

2-pentylcyclopentan-1-ol

Cas Number:

84560-00-9

IUPAC Name:

2-pentylcyclopentanol

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): ST 22 C 95
- Physical state: clear liquid
- Storage conditions: ambient temperature and humidity in the container in which it was received

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Trevanor Farm, Mainesburg, PA. USDA # 23-A-055.
- Age at study initiation: no data.
- Weight at study initiation: no data.
- Housing: individually housed in suspended stainless steel wire-mesh cages.
- Diet: Agway High Fiber Rabbit feed and Alfalfa cubes, ad libitum.
- Water: city water ad libitum.
- Acclimation period: at least 5 days.

ENVIRONMENTAL CONDITIONS
No data

IN-LIFE DATES:no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

Observations within 30-60 minutes after patch removal and at 24, 48 and 72 hours, and on Day 4, 7 and 14 after exposure.

Number of animals:

3 (Male or Female)

Details on study design:

TEST SITE
- Area of exposure: Dorsal area of the trunk, 6 cm² approximately
- Type of wrap if used: Patch held in place with non-irritating tape and covered with gauze which was then overwrapped with Elastikon tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to the OECD 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2 and #3

Time point:

other: mean 24, 48 and 72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Flaking skin in 2/3 at 72hrs; blanched skin in 1/3 at the three time points

Results 2

Irritation parameter:

edema score

Basis:

animal: #1 and #3

Time point:

other: mean 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: mean, 24, 48 and 72 hours

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

There was well-defined erythema and very slight oedema in 3/3 animals tested four hours post dosing. At 24 hours, all animals had well-defined erythema; 2 animals had very slight oedema, one animal had well-defined oedema.
At 48 and 72 hours there was well-defined erythema with one animal having blanched skin at the test site. Very slight oedema was noted in 2 animals, one animal had well-defined oedema.
On day 4, all animals had well-defined erythema and very slight oedema. One animal had blanched and flaking skin at the test site and one animal had flaking skin.
On day 7, 2 animals had very slight erythema, one of which had blanched skin. One animal had no erythema. All animals had flaking skin at the test site. There was no oedema noted.
On day 14, there was no erythema or oedema noted. All three animals had flaking skin.

Other effects:

All animal appeared normal during the observation period.

Any other information on results incl. tables

Table 7.3.1/1: Mean irritant/corrosive response data for each animal at each observation time up to removal of animals from the test

Score at time point / Reversibility	Erythema Max. score 4	Oedema Max. score 4
1 h	2 / 2 / 2	1 / 1 / 1
24 h	2 / 2 / 2	1 / 2 / 1
48 h	2B / 2 / 2	1 / 2 / 1
72 h	2B / 2 / 2	1 / 2 / 1
4 d	2BF / 2F / 2	1 / 1 / 1
7 d	1BF / 1F / 0F	0 / 0 / 0
14 d	0F / 0F / 0F	0 / 0 / 0
Average 24h, 48h, 72h	2.00 / 2.00 / 2.00	1.00 / 2.00 / 1.00
Reversibility*)	c.	c.
Average time for reversion	14 days	7 days

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

F = Flaking skin

B = Blanched skin at test site

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the test material induced irritation that persisted to the end of the observation period (flaking skin). The test item is therefore classified as category 2 irritant according to Regulation (EC) No. 1272/2008 (CLP).

Executive summary:

In a dermal irritation study performed according to the OECD guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test material was dermally applied on the clipped skin of the dorsal surface of the trunk of 3 New Zealand White rabbits. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 14 days for edema and erythema. 

Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the removal of the patch and on day 4, 7 and 14.

The scores calculated for each animal tested within 3 scoring times (24, 48 and 72 hrs) were 2.0/2.0/2.0 for erythema and 1.0/2.0/1.0 for oedema.

All 3 animals had flaking skin on Day 14.

 

Under the test conditions, the test material induced irritation that persisted to the end of the observation period (flaking skin).

 

Therefore, the test material requires a classification as irritating to skin H315, according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as reversibility of skin lesions was not achieved at the end of the 14-day observation period.

 

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.

The supporting substance is considered adequate for read-across purpose (see IUCLID section 13 for justification).