Benzoic acid, C12-15-alkyl esters

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

other: equivalent to standard acute method

Limit test:

yes

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:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

female, body weight at study start: 1.5 - 1.66 kg
male, body weight at study start: 1.51 - 1.87 kg
standard laboratory conditions
food and water ad libitum

Administration / exposure

Type of coverage:

other: trunk of each animal encased in a sleeve of plasticised material

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The animals were prepared by clipping the skin of the trunk free of hair. One-half of the animals were further prepared by introducing epidermal abrasions over the clipped skin surface, thus enhancing penetrability of the test material throug the stratum corneum.
Following the exposure period the sleeve was removed and the skin sites gently cleansed.

Duration of exposure:

24 hours

Doses:

2000 mg/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 and study end
- Other examinations performed: body weight and clinical signs

Statistics:

Limit test

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One dead animal was observed.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

not performed

Any other information on results incl. tables

 

Dosage (mg/KG)	Sex	# dead /# dosed	%
2000	3 M : 3 F	1/3 : 0/3	17

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal lethal dose (LD50) of the test material in albino rabbits was found to be greater than 2000 mg/kg bodyweight. The test material does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with EU labelling regulations Commission Directive 2001/59/EC.for classification and labelling of dangerous substances and preparations.

Executive summary:

The study was performed to assess the acute dermal toxicity of the test material in albino rabbits. A group of six animals (3 males and 3 females) was given a single, 24-hour dermal application of undiluted test material to intact and abraded skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. Mortality: There was one dead animal. Clinical Observations: There were no signs of systemic toxicity. Dermal Irritation: There were no signs of dermal irritation. Bodyweight: 3 animals showed expected gains in bodyweight and the other 3 animals showed body weight loss over the study period. Conclusion: The acute dermal lethal dose (LD50) of the test material in albino rabbits was found to be greater than 2000 mg/kg bodyweight.