Undec-10-enoic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-03-31 till 1999-04-14

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Undec-10-enoic acid

EC Number:

203-965-8

EC Name:

Undec-10-enoic acid

Cas Number:

112-38-9

Molecular formula:

C11H20O2

IUPAC Name:

undec-10-enoic acid

Details on test material:

- Physical state: Colorless liquid
- Analytical purity: 99.4%
- Stability under test conditions: stable in dark at RT
- batch 9807016 filling 41/99
- expiry data: Jan. 2000

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

SD ICO : OFA-SD (IOPS Caw)
TEST ANIMALS
- Source: Iffa Crédo, L`Arbresle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 251 +/-4 g (males) 227 +/-12g (females)
- Housing: individually during treatment in polycarvbonate cages on dust-free sawdust
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: in groups, at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2
- Humidity (%): 30-70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

one single administration of unchanged substance on gauze moistened with 2 ml water

Duration of exposure:

24 h

Doses:

2000 mg /kg BW

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

Animals observed frequently on day of treatment, afterwards once daily, for mortality and clinical signs;
no deaths observed.

Clinical signs:

other: Animals observed frequently on day of treatment, afterwards once daily, for mortality and clinical signs; no clinical signs and cutaneous reactions observed.

Gross pathology:

Necropsy and gross pathology was performed on day 15;
macroscopic examination revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions, the dermal LD0 of the test substance Undecylenic Acid is equal or higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose.

Executive summary:

The acute dermal toxicity of the test substance Undecylenci Acid (named ACIDE UDECYLENIQUE in this report) was evaluated in rats according to OECD No. 402 and EC 92/69/EEC B.3 guidelines. The test substance was applied in its original form at a dose of 2000 mg/kg to the skin of ten Sprague-Dawley rats (five males and five females) for 24 h, and animals were observed for 15 days. Mortality, clinical signs, reduction of body weight gain and abnormalities in gross pathology were not evident.

Under the experimental conditions, the dermal LD0 of the test substance Undecylenic Acid is equal or higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose.