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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984-05-22 till 1984-07-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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): UNDECYLENATE DE METHYLE
- Substance type: organic
- Physical state: clear yellowish liquid
- Analytical purity: 98%
- Impurities (identity and concentrations): no data
- Purity test date: 24.02.84
- Lot/batch No.: UNDECYLENATE DE METHYLE, Analyse 151
- Expiration date of the lot/batch: no data
- Stability under test conditions: not reported
- Storage condition of test material: not reported
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River France (76410 Saint-Aubin-les-Elbeuf, France)
- Age at study initiation: no data
- Weight at study initiation: 2.4 ± 0.08 kg
- Housing: individual housing in poly styrene cages 0,32 x 0,35 x 0,55 m
- Diet (e.g. ad libitum): pelleted rabbit diet ad libitum
- Water (e.g. ad libitum): Millipore filtered water ad libitum
- Acclimation period: one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 50% ± 20%
- Air changes (per hr): air filtered, non-recycled
- Photoperiod (hrs dark / hrs light): 12 h / 12 h


IN-LIFE DATES: From: 1984-05-15 To: 1984-05-25

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
3 days
Number of animals:
6 (males)
Details on study design:
TEST SITE
- Area of exposure: right flank (6 cm²)
- % coverage: 100 %
- Type of wrap if used: hydrophilic gauze bandage, kept in place by semiocculsive adhesive tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure:


SCORING SYSTEM: Draize's score

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, since no adverse skin reaction occurred
Irritant / corrosive response data:
No erythema and no oedema have been observed during the experiment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Guidance to Regulation (EC) No 1272/2008 on CLP of substances and mixtures
Conclusions:
No erythema and no oedema have been observed during the experiment. Therefore the test item has to be classified as non irritating to skin.
Executive summary:

The subject of this study was to determine the skin irritation potential of test item methyl 10 -undecenoate by an in-vivo study with rabbits acc. to OECD guideline 404 (topical application). A volume of 0.5 ml of undiluted test item was tested upon abraded rabbit skin. Contact time was 4 h, observation time 72 h. Neither erythema nor oedema has been noticed. According to the experimental conditions used, methyl10-undecylenate can be considered and classified as non-irritant.

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