Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997-11-13 to 1997-12-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study is classified as reliable without restrictions because it appears to adhere to OECD 420 guidelines, which was adopted to be a replacement for the first conventional acute toxicity test described in the OECD 401 test guideline. The study was also considered to be GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C24-C30 alkenes, branched and linear
- Substance type: Alkenes, C24-28
- Physical state: White paste

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, UK
- Age at study initiation: 10 to 14 weeks old
- Weight at study initiation: Males: 216 to 236 grams; Females: 204 to 230 grams
- Fasting period before study: Overnight fasting
- Housing: Housed in groups of five by sex in grid bottom polypropylene cages
- Diet (e.g. ad libitum): Rat and mouse expanded diet; ad libitum
- Water (e.g. ad libitum): Mains drinking water; ad libitum
- Acclimation period: 7days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21
- Humidity (%): 50 to 59
- Air changes (per hr): 15 changes/hours
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5000 mg/kg
- Amount of vehicle (if gavage): Data not reported
- Justification for choice of vehicle: Data not reported
- Lot/batch no. (if required): Data not reported
- Purity: Data not reported

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
5000 mg/kg
No. of animals per sex per dose:
5/sex/dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and overt signs of toxicity at 1, 2.5, and 4 hours after dosing and daily thereafter until study termination on day 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, and histopathology
Statistics:
Details regarding statistical analysis, if performed, is not provided in the report

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
None of the animals died during the course of the study.
Clinical signs:
Clinical observations included hunched posture and pilo-erection in males.
Body weight:
All animals exhibited normal body weight gain during the course of the study.
Gross pathology:
No abnormalities were noted during necropsy.

Any other information on results incl. tables

None of the animals died during the course of the study. Clinical observations included hunched posture and pilo-erection in males. All animals exhibited normal body weight gain during the course of the study and no abnormalities were noted during necropsy.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category V
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 for C24-C30 alkenes, branched and linear, in arachis oil BP in Sprague- Dawley rats is >5000 mg/kg.
Executive summary:

In an acute oral toxicity study, a range finding study was conducted to establish a dosing regimen for the main toxicity test. One male and one female Sprague-Dawley (Crl:CD®BR) rat were exposed to 5000 mg/kg of C24-30 Alkenes, branched and linear, via oral gavage using a metal cannula attached to a graduated syringe. Since both animals survived and no overt signs of toxicity were noted during the 14 day post dosing period, this dose was selected for the main study.

 

In the main acute toxicity study, five male and five female rats were treated with 5000 mg/kg of the test material via gavage. The animals were observed for mortality or overt signs of toxicity 1, 2.5, and 4 hours after dosing and once daily thereafter for 14 days until study termination. At study termination, the animals were sacrificed and necropsies were performed.

 

 

None of the animals died during the course of the study. Clinical observations included hunched posture and pilo-erection in males. All animals exhibited normal body weight gain during the course of the study and no abnormalities were noted during necropsy. Based on these results, the authors concluded that the acute oral LD50 for C24-C30 alkenes, branched and linear, in arachis oil BP in Sprague- Dawley rats is >5000 mg/kg.

 

This study received a Klimisch score of 1 and is classified as “reliable without restrictions” because it appears to adhere to OECD 420 guidelines, which was adopted to be a replacement for the first conventional acute toxicity test described in the OECD 401 test guideline. The study was also considered to be GLP compliant.