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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21/03/2018
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 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute 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

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test substance was applied in its original form at a dose level of 2000 mg/kg taking into consideration that the specific gravity of the test substance was 1.032 and directly to the skin of 10 Sprague-Dawley rats (5 males and 5 females). The test substance was held in contact with the skin by means of a semi-occlusive dressing for 24h.
Duration of exposure:
24 hours
Doses:
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)
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 single application of the test substance . A necropsy was performed on each animal found dead during the study 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
Mortality:
There was a 20% mortality rate at the dose level of 2000 mg/kg. It appeared on D2 (2females). No apparent signs were observed prior to death which was possibly to experimental stress caused by the dressing.
Body weight:
The general behaviour and bodyweight gain of the animals were not influenced by the treatment.
Gross pathology:
The macroscopic examination revealed no abnormalities in the animals found dead during the study or sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
sodium undec-10-enoate (in a 33.2% aqueous solution) administed by dermal route in the Rat was higher than 2000mg/kg, i.e. higher than 664 mg/kg of pure sodium undec-10-enoate. A 20% mortaliry was observed at this dose level.
Executive summary:

The acute dermal toxicity study was performed according to the OECD 402 guideline. -

The substance sodium undec-10-enoate (in a 33.2% aqueous solution) administed by dermal route in the Rat was higher than 2000mg/kg, i.e. higher than 664 mg/kg of pure sodium undec-10-enoate. A 20% mortaliry was observed at this dose level.