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Toxicological information

Acute Toxicity: oral

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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

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
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
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:
Animals that died did not eat or drink during the observation period. No clinical signs were reported for surviving animals.
Body weight:
Animals who died lost body weight.
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.