Methoxycarbonyloxycyclooct-4-ene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 25, 1985 - October 09, 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Remarks:

Study performed around/just before the time GLP was introduced in Europe, but internal QA statement.

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methoxycarbonyloxycyclooct-4-ene

EC Number:

401-620-8

EC Name:

Methoxycarbonyloxycyclooct-4-ene

Cas Number:

87731-18-8

Molecular formula:

C10H16O3

IUPAC Name:

(1R,3aS,6aS)-octahydropentalen-1-yl methyl carbonate; (1S,3aS,6aS)-octahydropentalen-1-yl methyl carbonate; (3Z)-cyclooct-3-en-1-yl methyl carbonate; (4Z)-cyclooct-4-en-1-yl methyl carbonate; bicyclo[3.2.1]octan-8-yl methyl carbonate

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: CD (Sprague-Dawley derived)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River U.K. Limited, Margate, Kent, UK
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: 206 to 228 g
- Housing: Individually housed in metal cages with wire mesh floors
- Diet: A standard laboratory rodent diet (Labsure LAD 1) was provided ad libitum
- Water: Water was provided ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 57 (daily mean)
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- One day prior to treatment hair was removed from the dorsolumbar region of each rat with electric clippers
- Area of exposure: 10% of the total body surface
- Type of wrap if used: gauze which was held in place with an impermeable dressing encircled firmly around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.89 mL/kg (relative density 1.0593)

Duration of exposure:

24 hours

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed directly after dosing; then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed at least twice per day. Clinical signs were recorded at each observation.
- Necropsy of survivors performed: yes, all animals were killed on Day 15 by cervical dislocation and were subjected to a macroscopic post mortem examination.
- Body weight: Individual bodyweights were recorded on Days 1 {day of dosing), 8 and 15.

Statistics:

Not performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred.

Clinical signs:

other: There were no clinical signs of reaction to treatment in any rat. No signs of dermal irritation at the treatment sites were noted during the study.

Gross pathology:

No abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:

other: Not harmful in accordance with EU CLP (EC no. 1272/2008 and its amendments)

Conclusions:

The substance has an LD50 of > 2000 mg/kg bw in an OECD TG 402 test.

Executive summary:

The substance was tested in an acute dermal toxicity study with male and female Sprague-Dawley rats (OECD TG 402). The substance was administered at a limit dose of 2000 mg/kg bw to 5 rats/sex. After 24 hours of exposure, there were no clinical signs of reaction to treatment in any rat and no mortality occurred. No signs of dermal irritation at the treatment sites were noted during the study. A zero bodyweight gain was recorded for two female rats on day 8. Normal bodyweight gains were recorded for these rats on day 15. At gross pathology no abnormalities were seen. The LD50 was concluded to be >2000 mg/kg bw.