Tetradecene

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:

1977-12-01

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restriction because although it is an acceptable and well documented study report a GLP statement was not provided and details regarding the test material and animal husbandry was not provided.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

no guideline available

Guideline:

other: not provided

Principles of method if other than guideline:

The internal olefin 114 LP11 was administered by intraoesophageal intubation using a ballpoint needle fitted to a syringe.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C11-15

IUPAC Name:

Alkenes, C11-15

Details on test material:

- Name of test material (as cited in study report): Internal olefin 114 LP11
- Test substance: Alkenes, C11-15

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Shell Toxicology Laboratory (Tunstall), Breeding Unit
- Age at study initiation: Approximately 12 weeks old
- Weight at study initiation: Not reported
- Fasting period before study: Overnight
- Housing: Four animals of one sex were housed in each cage.
- Diet (e.g. ad libitum): d libitum after dosing.
- Water (e.g. ad libitum): Ad libitum after dosing
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Route of administration:

other: intraoesophageal intubation

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE - Substance was undiluted

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual): No data

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data

Doses:

5.0 mL/kg and 10 mL/kg

No. of animals per sex per dose:

Four male and four female per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 9 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: No data
- Other examinations performed: No data

Statistics:

No data

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

approximate LD50

Effect level:

> 10 mL/kg bw

Remarks on result:

other: 10 mL/kg is equivalent to 7600 mg/kg

Effect levels 2

Sex:

male

Dose descriptor:

approximate LD50

Effect level:

10 mL/kg bw

Remarks on result:

other: 10 mL/kg is equivalent to 7600 mg/kg

Mortality:

No animals died at the 5.0 mL/kg dose level. Two male rats died at the 10 ml/kg dose level, no female rats died at this dose level.

Clinical signs:

other: Animals that died did not eat or drink during the observation period. No clinical signs were reported for surviving animals.

Gross pathology:

No data

Other findings:

- Organ weights: No data
- Histopathology: No data
- Potential target organs: No data
- Other observations: No data

Applicant's summary and conclusion

Conclusions:

No animals died at the 5.0 mL/kg dose level. Two male rats died at the 10 mL/kg dose level, no female rats died at this dose level. The estimated LD50 was calculated to be > 10 mL/kg (i.e., >7600 mg/kg) for females and 10 mg/kg (i.e., 7600 mg/kg) for male rats.

Executive summary:

In an acute oral toxicity study, two groups of four male and four female, fasted, approximately 12 week old, Wistar rats were given a single oral dose of Internal olefin 114 LP11 at doses of 5.0 and 10 mL/kg and observed for 9 days. 

 

No animals died at the 5.0 mL/kg dose level. Two male rats died at the 10 mL/kg dose level, no female rats died at this dose level. There were no treatment related clinical signs, necropsy data was provided. Animals who did not survive were reported to not eat or drink during the observation period, thus loosing weight. The oral LD50 was estimated to be approximately > 10 mL/kg in females (i.e., >7600 mg/kg) and 10 mL/kg (7600 mg/kg) in males.

 

This study received a Klimisch score of 2 and is classified as reliable with restriction because although it is an acceptable and well documented study report a GLP statement was not provided and details regarding the test material and animal husbandry was not provided.