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Toxicological information

Skin sensitisation

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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)

Resultsopen allclose all
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 %

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.