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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:
2008-09-17 to 2008-10-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restrictions because it was GLP compliant and followed OECD 420 guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Linealene Trimer A-30H
- Substance type: Decene trimer hydrogenated

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, United Kingdom
- Age at study initiation: Eight to twelve weeks
- Weight at study initiation: not reported
- Fasting period before study: yes
- Housing: groups of up to four in suspended solid floor polypropylene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 degrees Celsius to 25 degrees Celsius
- Humidity (%): 30% to 70%
- Air changes (per hr): atleast 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE - test material was used as supplied

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
Doses:
2000 mg/kg
No. of animals per sex per dose:
Five females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations were made 1/2, 1, 2, 4 hours after dosing and once daily for 14 days. Morbidity and mortality were checked twice daily.
- Necropsy of survivors performed: yes
Statistics:
Not applicable

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths
Clinical signs:
No signs of systemic toxicity were reported
Body weight:
All animals showed expected weight gain over the observation period
Gross pathology:
No abnormalities were reported.
Other findings:
None reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 for linealene dimer A-30H was greater than 2000 mg/kg.
Executive summary:

In an acute oral toxicity study, groups of fasted, five 12-week old Sprague-Dawley females were given a single oral dose of neat linealene dimmer A-30H at a limit dose of 2000 mg/kg bw and observed for 14 days. 

 

There were no mortalities, clinical signs of toxicity, body weight effects, or gross lesions observed. The oral LD50 was determined to be > 2000 mg/kg in females.

 

This study received a Klimisch score of 1 and is classified as reliable without restrictions because the study was GLP compliant and followed OECD 420 guidelines.