Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21/03/2002
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium undec-10-enoate
EC Number:
222-264-8
EC Name:
Sodium undec-10-enoate
Cas Number:
3398-33-2
Molecular formula:
C11H20O2.Na
IUPAC Name:
sodium undec-10-enoate
Specific details on test material used for the study:
sodium undec-10-enoate in a 33.2% aqueous solution administered at 2000mg/kg corresponds to 664 mg/kg of pure sodium undec-10-enoate.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
5 males and 5 females

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test substance was administered to a group of 10 fasted Sprague-Dawley rats (5 males and 5 females). The administration was performed with the test substance in its original form (sodium undec-10-enoate in a 33.2% aqueous solution) at a dose level of 2000 mg/kg (corresponds to 664 mg/kg of pure sodium undec-10-enoate) taking into consideration that the specific gravity of the test substance was 1.032.
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
the mortality, general behaviour and bodyweight gain of the animals were observed for a period of 14 days after the sigle administration of the test substance . A necropsy was performed on each animal sacrificed at the end of the study.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 664 mg/kg bw
Based on:
test mat.
Mortality:
no mortality at the dose level of 664 mg/kg of sodium undec-10-enoate.
Clinical signs:
the general behaviour of the animals was not influenced by the treatment.
Body weight:
A clear body weight loss was observed in one female between D1 and D5 without any effect on behaviour and any influence thereafter on the study. The bodyweight gain of the other animals was normal throughour the study.
Gross pathology:
The macroscopic examination revealed no abnormality in the animals sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
sodium undec-10-enoate (in a 33.2% aqueous solution) administered by oral route in the Rat was higher than 2000 mg/kg, i.e. higher than 664 mg/kg of pure sodium undec-10-enoate. No signs of toxicity were observed at this dose level.
Executive summary:

The acute oral toxicity study was performed according to the OECD 401 guideline. The substance sodium undec-10-enoate (in a 33.2% aqueous solution) administered by oral route in the Rat was higher than 2000 mg/kg, i.e. higher than 664 mg/kg of pure sodium undec-10-enoate. No signs of toxicity were observed at this dose level.