Reaction mass of [(1R,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1R,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of [(1R,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1R,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate

Molecular formula:

C14H22O2

IUPAC Name:

Reaction mass of [(1R,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1S,2S)-2-cyclopentylcyclopentyl] (E)-but-2-enoate and [(1R,2R)-2-cyclopentylcyclopentyl] (E)-but-2-enoate

Test animals

Species:

rat

Strain:

other: (Crl : CD BR)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, UK
- Age at study initiation: approx. 8-12 weeks
- Weight at study initiation: 204 - 212 g (males), 206 - 222 g (females)
- Housing: individually during the 24 h exposure period and subsequently 5 animals of the same sex per cage in polypropylene cages on woodflakes
- Diet: Rat and Mouse Expanded Diet No.1 (Special Diets Services Limited, Witham, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 49-64
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: 10%
- Type of wrap if used: The treated skin was covered with a surgical gauze which was held in place with a piece of self-adhesive bandage. The bandage was further secured with a piece of BLENDERM wrapped around each end.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was wiped with cotton wool moistened with distilled water to remove residual test substance.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2.05 mL/kg bw
- Constant concentration used: yes

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 0.5, 1, 2 and 4 h after administration and subsequently once daily for 14 days. Individual body weights were determined on Days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: After removal of the dressings and subsequently once daily for 14 days, the test sites were examined for evidente of primary irritation.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No signs indicative for systemic toxicity were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

No skin reactions were noted until the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In the conducted study, a LD50 value > 2000 mg/kg bw was derived.