Methyl undec-10-enoate

Skin irritation / corrosion

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

Test material information

Constituent 1

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.