Benzoic acid, C12-15-alkyl esters

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14. Dec. 1978 - 06. Feb. 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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)

GLP compliance:

no

Test type:

other: equivalent to standard acute tox 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

Molecular formula:

C19-22 H30-36 O2

IUPAC Name:

Benzoic acid, C12-15-alkyl esters

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

female, body weight at study start: 178 - 240 g
male, body weight at study start: 174 - 252 g
standard laboratory conditions
acclimatisation perid: 7 days
fasted overnight prior to administration of the test material
food and water ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 40 mL/KG

Doses:

range finding: 0.5, 1, 3, 5, 10, 25, 40 g/KG
main study: 30, 33, 37, 40 g/KG

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation after 1, 3, 6, 24 hours on the 1st day and daily thereafter; weighing at study start ans study end
- Necropsy of survivors performed: yes
- Other examinations performed: body weight and clinical signs

Statistics:

LD50 calculated according to Litchfield and Wilcoxin

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

34 500 mg/kg bw

Based on:

test mat.

Mortality:

Mortality started with second dose (33 g/KG).

Clinical signs:

other: Hair matted and unkempt Complete hair loss, scabs Crust-like substance covering entire skin surface Pyloric and intestinal mucosa reddened

Gross pathology:

Hair matted and unkempt
Complete hair loss, scabs
Crust-like substance covering entire skin surface
Pyloric and intestinal mucosa reddened

Any other information on results incl. tables

 

Dosage (g/KG)	Sex	# dead /# dosed	%
30	3 M : 3 F	0/3 : 0/3	0
33	3 M : 3 F	2/3 : 2/3	67
37	3 M : 3 F	3/3 : 2/3	83
40	3 M : 3 F	1/3 : 3/3	67

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral lethal dose (LD50) of the test material in Wistar rats was calculated as being 34500 mg/kg bodyweight. The test material does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC.

Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Wistar rat. Four groups of three fasted males and females were treated with the test material at dose levels of 30000, 33000, 37000 and 40000 mg/kg bodyweight. The test material was administered orally undiluted. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. Mortality: Mortality started with second dose (33 g/KG). Clinical Observations: Hair matted and unkempt Complete hair loss, scabs Crust-like substance covering entire skin surface Pyloric and intestinal mucosa reddened Bodyweight: Body weight loss starting with the second dose (33 g/KG) Necropsy:  Pyloric and intestinal mucosa reddened Conclusion: The acute oral lethal dose (LD50) of the test material in Wistar rats was calculated as being 34500 mg/kg bodyweight. The test material does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC.