Reaction mass of (1RS,2RS,7SR,8RS,9E)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2RS,7SR,8RS,9Z)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10E)-10-Ethylidene-3-oxatricyclo[6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10Z)-10-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: An acute dermal study performed under GLP and follows a method similar to an OECD guideline; limited test material characeterisation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (1RS,2RS,7SR,8RS,9E)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2RS,7SR,8RS,9Z)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10E)-10-Ethylidene-3-oxatricyclo[6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10Z)-10-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane

Molecular formula:

C12H18O

IUPAC Name:

Reaction mass of (1RS,2RS,7SR,8RS,9E)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2RS,7SR,8RS,9Z)-9-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10E)-10-Ethylidene-3-oxatricyclo[6.2.1.0(2,7)] undecane and (1RS,2SR,7SR,8SR,10Z)-10-Ethylidene-3-oxatricyclo [6.2.1.0(2,7)] undecane

Test material form:

other: liquid

Details on test material:

- Physical state: liquid

Test animals

Species:

rabbit

Strain:

other: albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: recognised animal source
- Age at study initiation: not reported
- Weight at study initiation: 2.1 - 2.8 kg
- Housing: The animals were housed 2/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: Certified rabbit feed ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS: not reported

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: abdomen
- Type of wrap if used: The test article was covered with a gauze patch and gentle pressure was applied to the gauze to aid the distribution of the test article over the prepared site. The torso was wrapped with plastic which was secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): site wiped.
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg

Duration of exposure:

24h

Doses:

5000 mg/kg

No. of animals per sex per dose:

2 males and 3 females.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The test sites were scored for dermal irritation at 24 hours post dose and on Days 7 and 14 using the numerical Draize scale. Additional signs were described. The animals were observed daily for 14 days for mortality, toxicity and pharmacological effect. Body weights were recorded pretest and at termination in the survivors.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One test animal died on day 1.

Clinical signs:

other: Yellow nasal discharge, few feces, lethargy, piloerection and ptosis were noted in 2/4 survivors and 2/4 were generally normal throughout the study. Dermal reactions, generally slight on Day 1 and severe on Day 7, cleared in 3/4 animals by Day 14.

Gross pathology:

Necropsy was normal for 1/4 survivors. The other 3/4 animals had lung, intestinal or treated skin abnormalities.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the LD50 was determined to be > 5000 mg/kg and so the test material is not considerd to be toxic to New Zealand rabbits via the dermal route.

Executive summary:

The study was performed to assess the dermal toxcity of the test material to New Zealand White rabbit. The study was performed under GLP and followed a method similar to OECD 402 guideline. The test substance was evaluated in 5 New Zealand white rabbits. A dose of 5000 mg/kg test substance (undiluted), was applied to intact and abraded clipped skin site under a occlusive dressing for 24 hours. Skin observations were made 24 hours after patch removal and then daily for 14 days for signs of toxicity, pharmacological effects and mortality. One rabbit died on Day 1. There were no predeath toxic signs or abnormalities at necropsy. Yellow nasal discharge, few feces, lethargy, piloerection and ptosis were noted in 2/4 survivors and 2/4 were generally normal throughout the study. Dermal reactions, generally slight on Day 1 and severe on Day 7, cleared in 3/4 animals by Day 14. Body weight changes were normal for 2/4 animals. One rabbit failed to gain and one animal lost weight. Necropsy was normal for 1/4 survivors. The other 3/4 animals had lung, intestinal or treated skin abnormalities. Under the conditions of this study the LD50 is considered to be greater than 5000 mg/kg.