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Description of key information

Non-sensitizer according to OECD TG 429

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
Qualifier:
according to
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)
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
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
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see field below (Any other information on results incl. tables)
Key result
Parameter:
SI
Value:
1.19
Test group / Remarks:
10 %
Key result
Parameter:
SI
Value:
2.16
Test group / Remarks:
25 %
Key result
Parameter:
SI
Value:
2.51
Test group / Remarks:
50 %

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

 

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-dioldid 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.




Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There is no information available for respiratory sensitisation. Therefore, there is a data gap in this respect. However, the data gap cannot be fulfilled with experimental data, since there is no internationally accepted animal model for respiratory sensitisation. In case human data for respiratory sensitisation emerges, this will be taken into account.

Justification for classification or non-classification

According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.4 this substance is not causing concern to be sensitizing.