4,7-Decanediol, 2,4,7,9-tetramethyl-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes

Remarks:

GLP Statement

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

2,4,7,9-tetramethyldecane-4,7-diol

EC Number:

451-160-7

Cas Number:

17913-76-7

Molecular formula:

C14H30O2

IUPAC Name:

2,4,7,9-tetramethyldecane-4,7-diol

Details on test material:

Lot Number: 12671
Purity: 98.3 %

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon (1 mouse), UK and B&K Universal Ltd, Hull UK (20 mice)
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 15 to 23 g
- Housing: suspended solid-floor polypropylene cages furnished with softwood woodflakes
- Certified Rat and Mouse Diet (Code 5LF2): ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

0% (vehicle control)
10%
25%
50%

No. of animals per dose:

5

Details on study design:

Method: OECD TG 429 Skin Sensitation: LLNA
Species/Strain: Mouse/CBA/CaOlaHsd
Vehicle: Acetone/olive oil (4:1)
Remarks: No significant deviations

Results and discussion

In vivo (LLNA)

Results

Results 1

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: see field below (Any other information on results incl. tables)

Results 2

Key result

Parameter:

SI

Value:

1.19

Test group / Remarks:

10 %

Results 3

Key result

Parameter:

SI

Value:

2.16

Test group / Remarks:

25 %

Results 4

Key result

Parameter:

SI

Value:

2.51

Test group / Remarks:

50 %

Any other information on results incl. tables

Test Substance Concentration        Proliferative response        Stimulation Index

(% v/v)                                           (DPM/lymph node) (Test/Control Ratio)

 

0 (vehicle control)                                       1580                                 -

10                                                              1878                               1.19       

25                                                              3414                               2.16

50                                                              3972                               2.51

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was considered to be a non-sensitiser under the conditions of the test.
The test material did not meet the criteria for classification as a sensitizer according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.

Executive summary:

2,4,7,9-tetramethyldecane-4,7-diol was considered to be a non-sensitizer under the conditions of the test. A study was performed to assess the skin sensitization potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of OECD Guideline 429. Following a preliminary screening test, three groups, each of five animals, were treated with 50 ml (25ml per ear) of the test material as a solution in acetone/olive oil 4:1 at concentrations of 10%, 25%, and 50% v/v. A further group of five animals were treated with acetone/olive oil 4:1 alone. The Stimulation Index (SI) expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows: Concentration (% v/v) in Acetone/olive oil 4:1 Stimulation Index (SI) Result 10 1.19 Negative 25 2.16 Negative 50 2.51 Negative 2,4,7,9-tetramethyldecane-4,7-diol did not meet the criteria for classification as a sensitizer according to EU labeling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.