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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Study period:

From June 13 to June 27, 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP study conducted according to OECD test Guideline No. 402. 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). The ennvironmental 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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Environmental conditions not reported, but GLP study so assumed to be adequate.

Principles of method if other than guideline:

not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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 in the container in which it was received

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

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: 2-3 kg bw
- Housing: individually housed in suspended stainless steel wire-mesh cages.
- Diet: Agway Prolab High Fiber Rabbit feed and Alfalfa cubes, ad libitum.
- Water: city water ad libitum.
- Acclimation period: at least 7 days.


ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10%
- Type of wrap if used: 15 cm² porous gauze patch overwrapped with a gauze strip and held in place with Elastikon tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, no details
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Dose volume = [Animal Weight (kg) x Limit Dose (2 g/kg)] / density (0.91 g/mL).
- Constant volume or concentration used: no

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily, 7 days a week. Observations included the following: skin and fur, and eyes and mucous membranes, circulatory, autonomic and central nervous systems and behaviour patterns.
- Necropsy of survivors performed: yes, gross necropsy after sacrifice by sodium pentobarbital.
- Other examinations performed: body weight, recorded just prior to administration and on day 7 and 14.

Statistics:

none

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality.

Clinical signs:

other: No clinical observations.

Gross pathology:

No gross abnormalities.

Other findings:

Dermal observation: on day 1, 5/5 females and 5/5 males had well-defined erythema. 3 females and 1 male had well-defined oedema; 2 females and 3 males had very slight oedema; 1 male had no oedema. On day 7, all animals had very slight erythema with flaking skin. There was no oedema noted. On day 14, there was no erythema or oedema noted. However, 4 females and the 5 males had flaked skin.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Dermal LD50 Combined > 2000 mg/kg bw

Executive summary:

In a limit acute dermal toxicity study performed according to the OECD guideline No. 402, groups of New Zealand White rabbit (5/sex)were semi-occlusively exposed to undiluted test material for 24 hours to 10% of the body surface at dose of 2000 mg/kg bw. The animals were observed for mortality, clinical signs including dermal reactions and body weight for 14 days and then necropsied for macroscopic observations.

 

No mortality occurred during the study. There were no signs of systemic reaction to treatment. No abnormality was revealed at autopsy. On day 1, erythema and oedema (score 2) were observed in all animals. On day 7, all animals had very slight erythema with flaking skin. There was no oedema noted. On day 14, there was no erythema or oedema noted. However, 4 females and the 5 males had flaked skin.

 

Dermal LD₅₀Combined > 2000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.

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