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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-03-20 till 1999-08-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl undec-10-enoate
EC Number:
203-910-8
EC Name:
Methyl undec-10-enoate
Cas Number:
111-81-9
Molecular formula:
C12H22O2
IUPAC Name:
methyl undec-10-enoate
Details on test material:
- Name of test material (as cited in study report): UNDECYLENATEDEMETHYLE
- Substance type: organic
- Physical state: liquid
- Analytical purity: 97.8 %
- Impurities (identity and concentrations):
- Purity test date: no data
- Lot/batch No.: 98 10006
- Expiration date of the lot/batch: July 1999
- Stability under test conditions: no data
- Storage condition of test material: at room temperature and protected from light
- Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Iffa Crkdo, L'Arbresle, France.
- Age at study initiation: 8 weeks
- Weight at study initiation: 248 +/- 8 g for the males and 236 +/- 15 g for the females
- Fasting period before study: no data
- Housing: During the treatment period, the animals were housed individually in polycarbonate cages (35.5 cm x 23.5 cm x 19.3 cm). Each cage contained dust-free sawdust.
- Diet (e.g. ad libitum): All the animals had free access to A04 C pelleted diet (UAR, Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
- Acclimation period: at least 5 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h


IN-LIFE DATES: From: 1999-03-24 To: 1999-04-07

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 cm x 6 cm for the females and 5 cm x 7 cm for the males
- % coverage: approximately 10% of the body surface of the animals
- Type of wrap if used: hydrophilic gauze pad


REMOVAL OF TEST SUBSTANCE
- Washing (if done): No residual test substance was observed at removal of the dressing.
- Time after start of exposure: not applicable


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation of the animals was made at least once a day until day 15. The animals were weighed individually just before administration of the test substance on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
no statistics applied

Results and discussion

Preliminary study:
As the test substance was anticipated to be non-toxic at 2000 mg/kg, a limit test was performed by application of 2000 mg/kg of the test substance to one group of ten animals
Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Mortality:
No death occurred during the study.
Clinical signs:
other: No clinical signs and no cutaneous reactions were observed during the study.
Gross pathology:
Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Guidance to Regulation (EC) No 1272/2008 on CLP of substances and mixtures
Conclusions:
Under the given experimental conditions, the dermal LDo of the test substance UNDECYLENATE DE METHYLE (batch No. 9810006) is equal to or higher than 2000 mg/kg in rats.
Executive summary:

The object of the study was to determine the acute dermal toxicity of test item UNDECYLENATE DE METHYLE according to OECD (No. 402, 24th February 1987) and EC (92/69/EEC, B.3, 31st July 1992) guidelines. Test subjects were male and female rats. Since the test substance was anticipated to be basically non-toxic, a fixed-dose limit test was carried out with a test item concentration of 2000 mg/kg. Under the given experimental conditions, the dermal LDo of the test substance UNDECYLENATE DE METHYLE (batch No. 9810006) is equal to or higher than 2000 mg/kg in rats.