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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
2,5,8,11-tetramethyldodec-6-yne-5,8-diol
EC Number:
269-348-0
EC Name:
2,5,8,11-tetramethyldodec-6-yne-5,8-diol
Cas Number:
68227-33-8
Molecular formula:
C16H30O2
IUPAC Name:
2,5,8,11-tetramethyldodec-6-yne-5,8-diol
Constituent 2
Reference substance name:
2,5,8,11-tetramethyl-5,8-dodecanediol
IUPAC Name:
2,5,8,11-tetramethyl-5,8-dodecanediol
Details on test material:
Batch # 20702
Purity: 98.1 %

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes. Free access to mains tap water and food (2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed throughout the study. The temperature and relative humidity were controlled to remain within target ranges of 19 to 25°C and 30 to 70%, respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18:00) and twelve hours darkness.

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
0, 10, 25 and 50%
No. of animals per dose:
5 animals per dose
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
other: Phenylacetaldehyde

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
0.72
Test group / Remarks:
10 %
Remarks on result:
other: see table
Key result
Parameter:
SI
Value:
0.67
Test group / Remarks:
25 %
Remarks on result:
other: see table
Key result
Parameter:
SI
Value:
1.15
Test group / Remarks:
50 %
Remarks on result:
other: see table

Any other information on results incl. tables

Concentration (% w/w) in acetone/olive oil 4:1 Animal Number dpm/Animal Mean dpm/Animal (Standard Deviation) Stimulation Index Result
vehicle 1-1 2765.46 3028.22 (+/-943.70) N/A N/A
1-2 3536.85
1-3 4286.41
1-4 2786.30
1-5 1766.08
10 2-1 3646.00 2210.03 (+/-773.55) 0,73 Negative
2-2 2078.34
2-3 3021.69
2-4 2324.61
2-5 979.51
25 3-1 2036.38 2023.63 (+/-1098.19) 0.67 Negative
3-2 772.23
3-3 1702.64
3-4 37.99
3-5 1818.92
50 4-1 3457.05 3469.92 (+/-406.22) 1.15 Negative
4-2 2994.34
4-3 3370.17
4-4 4118.13
4-5 3409.93

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.
Executive summary:

The test material was considered to be a non-sensitiser under the conditions of the test according to OECD 429.