Benzoic acid, 4-[(1-oxodecyl)oxy]-

Acute Toxicity: oral

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

Test material information

Constituent 1

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.