Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

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:
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
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)
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.
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
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

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
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.

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

The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group has been 1.15 at 50 % concentration. Ergo: negative!


 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

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.