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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium sebacate
EC Number:
241-300-3
EC Name:
Disodium sebacate
Cas Number:
17265-14-4
Molecular formula:
C10H18O4.2Na
IUPAC Name:
disodium sebacate
Test material form:
solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6-7 weeks.
- Weight at study initiation: ♂ 168 g, ♀ 146 g
- Housing: Animals were caged separated
- Fasting period before study: 18 h
- Diet: ad libitum, commercial pelleted diet (Oakes Special Diet with added Vit. E)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±2
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 5000 mg/kg
- Amount of vehicle: 25% (w/v) solution, 20 mL/kg
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical symptoms, gross pathology




Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No substance related mortality was seen.
Clinical signs:
other: No substance related clinical effects were seen.
Gross pathology:
No pathological substance related changes were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met