Dodecene

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1993-09-13 to 1993-11-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restrictions because it was conducted in accordance with OECD 402 guidelines and was GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octadecene

EC Number:

248-205-6

EC Name:

Octadecene

Cas Number:

27070-58-2

IUPAC Name:

octadec-1-ene

Details on test material:

- Name of test material (as cited in study report): C18 Isomerised Olefin
- Substance type: C18 isomerised olefin
- Physical state: Clear colourless liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas
- Age at study initiation: 3 to 6 months
- Weight at study initiation: Males: 2.400 to 2.725 kg; Females: 2.400 to 2.950 kg
- Housing: Suspended, wire bottom, stainless steel; one animal per cage
- Diet (e.g. ad libitum): Purina Rabbit Chow; fed in measured amounts
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal surface of the trunk
- % coverage: 10%
- Type of wrap if used: Surgical gauze covered with non-irritating adhesive tape which was further covered with semi-permeable dressing and again wrapped with non-irritating adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with room temperature tap water and a clean wet cloth
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.35 mL/kg equivalent to 2020 mg/kg
- Concentration (if solution): Not applicable
- Constant volume or concentration used: Yes

Duration of exposure:

24 hours

Doses:

2020 mg/kg

No. of animals per sex per dose:

5 males and females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0.5, 3, and 6 hours after exposure and daily until day 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and body weight

Statistics:

Statistical analysis, if performed, is not presented in the study report.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 020 other: mg/kg

Mortality:

No mortality was observed during the course of the study.

Clinical signs:

other: The only notable observation was slight diarrhoea in one female on days 9 and 10.

Gross pathology:

No observable abnormalities were noted.

Any other information on results incl. tables

Body weight gain was affected from exposure to octadecene. Four males and females either lost weight or failed to gain weight between days 7 and 14. Toxicological and pharmacological signs were not noted. There were no signs of dermal irritation during the 14 day observation period. The only notable observation was slight diarrhoea in one female on days 9 and 10. Gross necropsy at study termination revealed no observable abnormalities. None of the treated animals died during the course of the study. Based on these results, the LD50 for octadecene in albino rabbits is > 2020 mg/kg (2.35 mL/kg)

 

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg) Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 for octadecene is greater than 2020 mg/kg.

Executive summary:

In an acute dermal toxicity study, five male and female New Zealand White rabbits were clipped free of hair on the dorsal surface of the trunk. Care was taken to ensure that the exposed skin was not abraded. All animals were treated with 2020 mg/kg (2.35 mL/kg) undiluted octadecene and exposed for 24 hours. After 24 hours, animals were observed for toxicological and pharmacological effects and mortality at 0.5, 3, and 6 hours after treatment and at least once daily until study termination on day 14. Animals were sacrificed for necropsy on day 14.

 

Body weight gain was affected from exposure to octadecene. Four males and females either lost weight or failed to gain weight between days 7 and 14. Toxicological and pharmacological signs were not noted. There were no signs of dermal irritation during the 14 day observation period. The only notable observation was slight diarrhoea in one female on days 9 and 10. Gross necropsy at study termination revealed no observable abnormalities. None of the treated animals died during the course of the study. Based on these results, the LD50 for octadecene in albino rabbits is > 2020 mg/kg (2.35 mL/kg).

 

This study received a Klimisch score of 1 and is classified as “reliable without restrictions” because it was conducted in accordance with OECD 402 guidelines and was GLP compliant. This study will influence the DNEL(s).