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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:
other: the general behaviour of the animals was not influenced by the treatment.
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.