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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP guidance or equivalent. However, the limited information provided indicates that this study was conducted in a manner similar to OECD 420 guideline.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
not specified
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
111-66-0
Molecular formula:
C8H16
Details on test material:
- Name of test material (as cited in study report): 1-Octene alpha olefin C8
- Physical state: Liquid
- Other: Density 0.716 g/mL
Specific details on test material used for the study:
- Name of test material (as cited in study report): 1-Octene alpha olefin C8
- Physical state: Liquid
- Other: Density 0.716 g/mL

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
No data reported.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Undiluted
Doses:
10,000 mg/kg undiluted
No. of animals per sex per dose:
10 male rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes
Statistics:
No data reported.

Results and discussion

Preliminary study:
Oral LD50> 10,000 mg/kg
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
All animals survived.
Clinical signs:
other: All animals survived without any signs toxicity.
Gross pathology:
Autopsy revealed no visible pathological changes.
Other findings:
No data reported.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg)
Conclusions:
The study reported LD50 to be greater than 10,000 mg/kg.
Executive summary:

In an acute oral toxicity study, 10 fasted, male Sprague-Dawley rats were given a single oral dose of undiluted 1-octene at a dose of 10,000 mg/kg and observed for 14 days. There were no treatment related clinical signs, necropsy findings or changes in body weight reported in the study. The oral LD50 was determined to be greater than 10,000 mg/kg in males.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because there is no statement regarding whether this study was conducted according to GLP guidance or equivalent. However, the limited information provided indicates that this study was conducted in a manner similar to OECD 401 guideline.