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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzoic acid, 4-[ (1-oxodecyl) oxy]-
EC Number:
617-941-3
Cas Number:
86960-46-5
Molecular formula:
C17H24O4;
IUPAC Name:
Benzoic acid, 4-[ (1-oxodecyl) oxy]-

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27, D-33178 Borchen
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: mean = 178.8 g
- Fasting before study: yes
- Housing: in transparent macrolon® cages (type IV) on soft wood granulate* in an air-conditioned room, 3 animals per cage
- Diet (e.g. ad libitum): ssnif® R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 % suspension
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle: stability and homogeneity

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to toxicity data of related compounds
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
other: no symptoms
Gross pathology:
no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Acute oral toxicity testing of the test item in the female rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight.
Executive summary:

The test item was tested for acute oral toxicity in femal rats according to OECD guideline 423 (limit test).

After administration of 2000 mg/kg body weight neither deaths nor symptoms occurred.

One female animal showed a small loss of body weight at the end of the study. In the other animals development of body weight was not impaired.

All animals were killed at the end of the observation period. They showed no macroscopically visible changes.