3-(1-ethoxyethoxy)-3,7-dimethylocta-1,6-diene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 July, 1980 - 04 August, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well described short report. Dose, number of animals (with details), experimental design and observation period are described in the study. Performed in compliance with the FDA's GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar 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:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Elintaal
- Description: Clear liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Perfection breeders
- Age at study initiation: approx. 9 weeks old
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: Two animals per cage were housed in suspended wire mesh cages.
- Diet: Fresh Purina rabbit chow was freely available
- Water: Water was freely available
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Immediately prior to dosing, the fur was clipped from the abdomen of the animals.
- Area of exposure: 200 square cm
- % coverage: approx. 10% of the body surface
- Abrasions were made in 1/2 of the rabbits. The abrasions, extending the length of the exposure site, scratched the stratum corneum but did not reach the derma or produce bleeding.
- The patches were secured with adhesive tape and the trunks were wrapped with impervious material.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, exposure site was wiped to remove excess material.

TEST MATERIAL
- Amount applied: the dose was based on the sample weight as calculated from the specific gravity.

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Dermal reactions were scored at 1, 7 and 14 days after removal of the patches.
The animals were observed daily for 14 days for signs of toxicity, clinical signs and mortality.
Body weights were recorded pretest and in the survivors at 14 days.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: Diarrhea and yellow nasal discharge was observed (in 2 animals).

Gross pathology:

No abnormalities were observed.

Other findings:

Erythema was observed, slight/well defined on days 1 and 7, generally cleared by day 14.
Edema was observed, absent to severe on day 1, completely cleared on day 14.
Treated skin was found damaged in 2 animals at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal toxicity with male rabbits, an LD50 >5000 mg/kg bw was determined.

Executive summary:

Elintaal was tested in an acute dermal toxicity study with male rabbits at 5000 mg/kg body weight. The study was performed equivalent to OECD 402 guideline and GLP principles. No deaths occurred. Diarrhea and yellow nasal discharge was observed.

Erythema was observed, slight/well defined on days 1 and 7, generally cleared by day 14. Edema was observed, absent to severe on day 1, completely cleared on day 14. Treated skin was found damaged in 2 animals at necropsy. Based on the results, an LD50 >5000 mg/kg bodyweight was determined.