Benzoic acid, 4-hydroxy-, C18-22-alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(1981)

Deviations:

yes

Remarks:

(study report with limited information)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid, C12-15-alkyl esters

EC Number:

270-112-4

EC Name:

Benzoic acid, C12-15-alkyl esters

Cas Number:

68411-27-8

IUPAC Name:

68411-27-8

Details on test material:

- Name of test material (as cited in study report): trade name
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: 1950
- Specific gravity: 0.94

Test animals

Species:

rat

Strain:

other: Albino rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 174-252 g

No further details are given in the study report

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 40 mL/kg bw (maximum mechanically feasible dose)

DOSE SELECTION RATIONALE: Range finding study

Doses:

Range Finding Study:
- 1 male each dosed with 500 and 1000 mg/kg bw
- 1 female each dosed with 3000, 5000, 10,000, 25,000 and 40,000 mg/kg bw

Main Study:
- 30,000, 33,000, 37,000 and 40,000 mg/kg bw

No. of animals per sex per dose:

Range Finding Study:
- 1 male or female, respectively

Main Study:
- 3 males and 3 females

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
No further details are given in the study report.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

34 500 mg/kg bw

Based on:

test mat.

95% CL:

32 540 - 36 570

Mortality:

Range Finding Study:
- 1 male dosed with 1000 mg/kg bw (probable non-dose related death)
No further mortality occurred throught the range finding study.

Main Study:
- No mortality was observed in the 30,000 mg/kg bw dose group.
- 2/3 males and 2/3 females died in the 33,000 mg/kg bw dose group.
- 3/3 males and 2/3 females died in the 37,000 mg/kg bw dose group.
- 1/3 males and 3/3 females died in the 40,000 mg/kg bw dose group.

Clinical signs:

other: No details given in the study report.

Gross pathology:

No details given in the study report.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified