Sebacic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Sebacic acid

EC Number:

203-845-5

EC Name:

Sebacic acid

Cas Number:

111-20-6

Molecular formula:

C10H18O4

IUPAC Name:

sebacic acid

Test material form:

solid

Details on test material:

- Name of test material: Acido Sebacico
- Physical state: white solid
- Analytical purity: 100 %
- Lot/batch No.: 981105
- Storage condition of test material: at room temperature

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source batch number of test material: 981105
- Expiration date of the batch: September, 2003

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: no more tha three months
- Weight at study initiation: male: 290 - 350 g; female: 247-286 g
- Housing: 5 animal per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2
- Humidity (%): 55 % ± 10
- Air changes (per hr): 15-20 /hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6x5 cm
- % coverage: 10

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

24 hours before the test, fur was clipped from the dorsal and ventral area of the trunk of the test animals. Care was taken to avoid abrading the skin which could alter its permability. An area of about 6x5 cm of the body dorsal surface was cleared for the application of the test article. This area corresponded to about 10% of the total body surface.
The test article was applied uniformly onto a porous gauze which was moistened with 0.9% NaCl solution. The treated area was covered with the porous gauze dressing fixed to the skin with hypoallergenic non-irritaing tape. The test site was further covered in a suitable manner in order to ensure that the animals could not ingest the test substance. At the end of the exposure period the residual test article was wiped off with water.

- Duration of observation period following administration: 14 days
- Frequency of observations : 30 min, 2, 4 and 6 hours on the first day after the administration, twice a day up to termination
- Other examinations performed: clinical signs, body weight, histopathology, gross pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No general or local clinical abnormalities were seen in any animal.

Gross pathology:

No apprecible changes were evident in the treated animals of either sex at the autopsy carried out at the end of the observation period.

Any other information on results incl. tables

The day of treatment was considered day 1 of the study. The animals were weighed twice before treatment (at randomization and on day 1 just before treatment) and on day 8 and 15. They were clinically observed for 14 days after the 24 -hour exposure period. On day 16 all rats were killed (fasted overnight) by excision of the femoral arteries after i.p. overdosage anesthesia with 5% sodium pentobarbital and were submitted to a thorough autopsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No animals died and no general or local clinical signs or body weight abnormalities were observed in any treated rat during the observation period. No macroscopic findings were evident at the final autopsy.
In conclusion, the test substance, when administerd by dermal route to the rat, did not cause mortality or show appreciable toxic effects at the limit dose of 2000 mg/kg.
The LD50 by dermal route is higher than 2000 mg/kg.