Registration Dossier

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:
other: GLP-study without deviations according to OECD-guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Animals observed frequently on day of treatment, afterwards once daily, for mortality and clinical signs;
no clinical signs and cutaneous reactions observed.
Body weight:
Body weight was monitored on day 1 and 15; body weight gain not influenced by treatment.
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:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
According to GHS criteria, no classification of Undecylenic Acid is required.
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.