Esterification products of salicylic acid and C13-(branched) alcohols

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 November 1997 to 28 January 1998

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EEC 92/69

Version / remarks:

study was performed to obtained information about evaluation of toxicity effect in accordance to EEC 92/69.

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tridecyl 2-hydroxybenzoate

EC Number:

947-975-7

Molecular formula:

C20H32O3

IUPAC Name:

tridecyl 2-hydroxybenzoate

Specific details on test material used for the study:

Denomination COSMACOL ESI
Batch 28L6
Production date November 1996
Identification sample n.: 19558
Receiving n. R05068.97
Receiving date November 13, 1997

Test animals

Species:

rat

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

Species Rats
Strain CD
N. 10
Weight 225-231 g
Sex Males and Females
Supplier Charles River - Calco (CO)

EXPERIMENTAL DESIGN

10 white rats were used (5 males, 5 females).


Caging

The animals were caged in groups of 5 of the same gender m transparent polycarbonate cages (dimensions mm 425x266xl 80h).
The housing room was mantained under the following conditions:
Temperature: 22°c ±2°C
R.H.: hair was changed at least 25 times per hour and maintained at a pressure higher than the outside atmosphere
Artificial lighting: 12 h/day

Cleaning and disinfection
The cages and the housing room were cleaned and disinfected before the animals were accomodated, then cleaning and disinfection were performed periodically

Feeding
Animals were fed with standard pellet complete diet supplied by the authorized breeder Rieper.

Watering
Filtered tap water from local network was supplied ad libitum.

Animal identification
Each animal was identified with an indelible colouring in different parts of the body.
No sign 1
Head 2
Back 3
Tail 4
Head +tail 5

Cages were labelled.

Quarantine
Before being used in this study, the animals were kept in quarantine for one week. During this period they were observed daily.
At the end of the quarantine week the animals were carefully examined in order to evaluate their suitability for the study.

Animal selection
The animals used for this study were selected randomly from those suitable, available at that time.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Skin preparation
24 hours before the test the fur was removed from an area approximately 20 cm2 wide by clipping and shaving the dorsal and flank zones of the animals.

Administration
Square gauze pads 2.5 cm x 2.5 cm fixed to adhesive tape (Hansamed strips) were used. 2000 mg/kg of the assay sample were placed under the pad, which was kept in place by means of thin bands of adhesive hypoallergenic tape (Blenderm 3M).
The entire trunk of the animal was then wrapped with rubberized cloth (Acrylastic Beyersdorf AG Hamburg).

Removal ofthe patches
The patches were removed 24 hours after the application.
The exceeding paste was then washed away from skin using a pad soaked in distilled water.

Duration of exposure:

24 h

Doses:

1

No. of animals per sex per dose:

5 male
5 femal

Control animals:

not required

Details on study design:

OBSERVATIONS

The general welfare of the animals was observed daily for 14 days. All observation were recorded daily in a form dated and signed.
In the course of the study the following was observed:

Mortality
The animals were observed every morning of the working week.

Clinical symptoms
Any clinical symptoms including variations of somatomotor activity were recorded daily for each animal.
Clinical observations included:

evaluation of organic bodys functions; evaluation of tegumentary apparatus; evaluation of mucosae conditions;
evaluation of somatomotor activity and sensorium conditions.

Bodyweight
Animals were weighed before the experiment, after 7 days and then at the end of the study.

Necropsy
At the end of the observation period rats were sacrificed and a necroptic survey was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No cases of mortality were observed during the study.

Clinical signs:

other: During the study in all treated animals no abnormalities were observed (see appendix)

Gross pathology:

At the autopsy in all treated animals no abnormalities was observed.

Applicant's summary and conclusion

Conclusions:

The DL50 is superior to 2000 mg/kg.

Executive summary:

This study was performed to obtain information about the toxicity effect of teh test substance in accordance to EEC 92/69. The DL50 is superior to 2000 mg/kg.