Cyclopentaneacetic acid, 3-oxo-2-pentyl-, methyl ester, (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:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Acceptable, well-documented publication/study carried out according to national standards. The supporting substance is considered adequate for read-across purpose as data relates to a mixture of cis- and trans-isomers whereas the registered substance is the pure cis-isomer (see Iuclid section 13 for additional justification).

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: US-Federal Hazardous Substance Act (FHSA) Guideline 16.CFR 1500.40

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 3-oxo-2-pentylcyclopentaneacetate

EC Number:

246-495-9

EC Name:

Methyl 3-oxo-2-pentylcyclopentaneacetate

Cas Number:

24851-98-7

IUPAC Name:

methyl (3-oxo-2-pentylcyclopentyl)acetate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Hedione
- Substance type: pure active substance

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not provided in study report
- Age at study initiation: Not provided in study report
- Weight at study initiation: Not provided in study report
- Fasting period before study: Not provided in study report
- Housing: Not provided in study report
- Diet (e.g. ad libitum): Not provided in study report
- Water (e.g. ad libitum): Not provided in study report
- Acclimation period: Not provided in study report


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not provided in study report
- Humidity (%): Not provided in study report
- Air changes (per hr): Not provided in study report
- Photoperiod (hrs dark / hrs light): Not provided in study report

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: area ca. 12 cm wide covering the entire circumference of the rabbit. Skin was abraded
- % coverage: > 10% body surface area
- Type of wrap if used: animals were wrapped with binders of rubber dam, gauze and adhesive tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g/kg

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw (limit test)

No. of animals per sex per dose:

10 (sex not specified)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animal were weighted before and after treatment and were observed 24 hours after application and for a period of 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, skin irritation

Statistics:

Not applicable (limit test)

Results and discussion

Preliminary study:

Not performed/Not Applicable

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no 95% CL provided

Mortality:

One rat died after 3 days

Clinical signs:

other: Diarrhea was observed in 4 rabbits on day 1 (reversible)

Gross pathology:

No abnormalities were noted

Other findings:

Skin irritation, type of irritation observed and number of rats reacting:
- Slight redness: 3, Moderate redness: 7
- Slight oedema: 6, Moderate oedema: 3

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Dermal LD50 > 5000 mg/kg bw.

Executive summary:

Introduction. Acute dermal toxicity of the test material was determined according to the Federal Substance Hazardous Act (FHSA) test guideline 16 CFR 1500.40 on acute dermal toxicity.

Methods. Pure test material was tested at a unique dose level of 5000 mg/kg bw in occlusive conditions for 24 hours on abraded skin in a group of ten New Zealand white albino rabbits. Animals were observed for 14 days for mortality, clinical signs and bodyweight changes. A necropsy was performed on all animals at the end of the study.

Results and conclusions. Diarrhea was observed in four animals on day 1 and one animal died on day 3. The harsh skin test conditions used in that test (48h exposure on abraded skin, occlusive conditions) lead to local skin irritation in some animals. No clinical signs were otherwise observed, expected bodyweight gains were monitored at the end of the study and no abnormalities were noted during the necropsy.

The LD50 was therefore determined to greater than 5000 mg/kg bw and the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.

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 as data relates to a mixture of cis- and trans-isomers whereas the registered substance is the pure cis-isomer (see Iuclid section 13 for additional justification).