Dodecene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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 1993-11-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restrictions because it was conducted according to GLP guidance and was generally in accordance with OECD 420 guidelines.

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 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

yes

Test type:

fixed dose procedure

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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc., Houston, Texas
- Age at study initiation: Young adult
- Weight at study initiation: Males (211 to 228 grams); Females (194 to 208 grams)
- Fasting period before study: 16 hours
- Housing: One per cage; Suspended , wire bottom, stainless steel
- Diet (e.g. ad libitum): Purina Formulab Chow #5008; ad libitum
- Water (e.g. ad libitum): Tap, ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.88 mL/kg equivalent to 5050 mg/kg

Doses:

5050 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: Three times on day the test chemical was administered and at least once daily thereafter until study termination on 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:

> 5 050 other: mg/kg

Mortality:

No mortality was observed during the course of the study.

Clinical signs:

other: Notable observations included diarrhoea, piloerection and polyuria.

Gross pathology:

No observable abnormalities were noted.

Any other information on results incl. tables

Body weight gain was unaffected as a result of exposure to octadecene. Toxicological and pharmacological signs were not noted. Notable observations included diarrhoea, piloerection, and polyuria. 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 acute oral LD50 for octadecene in Sprague Dawley rats is > 5050 mg/kg (5.88 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 oral LD50 for octadecene is greater than 5050 mg/kg.

Executive summary:

In an acute oral toxicity study, five male and female young adult Sprague-Dawley rats were administered 5050 mg/kg (5.88 mL/kg) of octadecene via oral intubation. Following treatment, the animals were observed for toxicological and pharmacological effects and mortality at least three times on the day of treatment and at least once daily until study termination on day 14. Individual body weights were noted prior to treatment and on days 7 and 14. Animals were sacrificed for necropsy on day 14.

 

Body weight gain was unaffected as a result of exposure to octadecene. Toxicological and pharmacological signs were not noted. Notable observations included diarrhoea, piloerection, and polyuria. 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 acute oral LD50 for octadecene in Sprague Dawley rats is > 5050 mg/kg (5.88 mL/kg).

 

This study received a Klimisch score of 1 and is classified as “reliable without restrictions” because it was conducted according to GLP guidance and was generally in accordance with OECD 420 guidelines. This study will influence the DNEL(s).