3,7,11-Trimethyldodec-1-en-3-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

August 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Principles of method if other than guideline:

- Principle of test: in-vitro test
- Short description of test conditions: A concentration of 100% of the test substance was used at pH of 7. No direct MTT reduction was obseved for the test substance.
- Parameters analysed: The Optical Density (OD) at a wavelength of 570 nm was tested and the viability calculated according to the results obtained.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,7,11-trimethyldodec-1-en-3-ol

EC Number:

609-221-2

Cas Number:

3625-46-5

Molecular formula:

C15H30O

IUPAC Name:

3,7,11-trimethyldodec-1-en-3-ol

Test material form:

liquid

Details on test material:

Tetrahydronerolidol (THNER)
CAS No. 3625-46-5
Batch No.: Anlage 067, 13 Jun 2001
Purity: 96 %

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Batch No.of test material: Anlage 067, 13.06.01
- Substance number: 01/0405-1

In vitro test system

Justification for test system used:

With the EpiDerm Corrosivity Test the corrosivity of test articles can be determined.

Vehicle:

unchanged (no vehicle)

Details on test system:

Two tissues were used

Control samples:

yes, concurrent negative control

Amount/concentration applied:

TEST MATERIAL
- Concentration: 100%

Duration of treatment / exposure:

Exposure: 3 min and 1 h

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Exposure after 3 min and 1 h

Value:

> 94 - < 98

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

The viability after 3 min and 1 h exposure of the undiluted test substance was 94 % and 98 %, respectively.
The viability after 3 min and 1 h exposure of the positive control was 8 % and 8 %, respectively.

Exposure time: 3 min.
tissue 1 tissue 2 mean OD viability
(570 nm) (570 nm) (570nm) [% of NC]
---------------------------------------------------
NC 1.884 1.864 1.874 100
TS 1.790 1.725 1.758 94
PC 0.149 0.166 0.157 8

NC = negative control
TS = test substance
PC = positive control

Exposure time: 1 hour
tissue 1 tissue 2 mean OD viability
(570 nm) (570 nm) (570nm) [% of NC]
---------------------------------------------------
NC 2.241 2.110 2.176 100
TS 2.146 2.108 2.127 98
PC 0.123 0.195 0.159 8

NC = negative control
TS = test substance
PC = positive control

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The test substance did not show effects in the EpiDerm Corrosivity-Test in vitro and thus, it was concluded that the test substance does not induce severe skin irritation. However, possible skin irritancy cannot be evaluated in this test system.

Executive summary:

The EpiDerm Corrosivity-Test in vitro was used to assess the potential to induce severe skin irritations of the test substance at a concentration of 100% (undiluted). Exposure times were set to three minutes and one hour. No direct MTT reduction was observed. The viability was analyzed with optical density at 570 nm. The test substance generated a viability of 94% and 98% after three minutes and one hour exposure, respectively. The negative and the positive control revealed valid results of 100% and 8%, respectively, both after three minutes and one hour exposure.