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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study done according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions. Klimisch rating = 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
3,5-dimethylhex-1-yn-3-ol
EC Number:
203-500-9
EC Name:
3,5-dimethylhex-1-yn-3-ol
Cas Number:
107-54-0
Molecular formula:
C8H14O
IUPAC Name:
3,5-dimethylhex-1-yn-3-ol
Test material form:
liquid: viscous
Details on test material:
Batch #: 1602145

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Female CBA/Ca (CBA/CaOlaHsd) strain mice were supplied by Harlan Laboratories UK Ltd., Oxon, UK. On receipt the animals were randomly allocated to cages. The animals were nulliparous and non-pregnant. After an acclimatization period of at least five days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and number written on a cage card. At the start of the study the animals were in the weight range of 15 to 23 g, and were eight to twelve weeks old.
The animals were group housed in suspended solid floor polypropylene cages furnished with softwood woodflakes. Free access to mains tap water and food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study.
The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70 %, respectively. 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.
The animals were privided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
100, 50 and 25 %
No. of animals per dose:
5 mice per dose
Details on study design:

TREATMENT PREPARATION AND ADMINISTRATION: The mice were treated with the undiluted test item or the test item at concentrations of 50 or 25 % v/v in acetone/olive oil 4:1. The mice were treated by daily application of 25 µL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days.
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
Data was processed to give group mean values for disintegration per minute and standard deviations where appropriate. Individual and group mean disintegrations per minute values were assessed for dose response relationships. Data was first assessed for suitability by analysis of normality and homogeneity of variance. If the assumption that the data are both normally distributed and has homogeneity of variances, then parametric one way analysis of variance (ANOVA) and Dunnett´s multiple comparison procedure were used determine statistical significance. If the assumptions were not met, non parametric Kruskal Wallis Rank Sum and Mann Whitney U test procedures were used.

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
Concentration (% v/v) Mean dpm/Animal Stimulation Result in acetone/olive oil 4:1 (Standard Deviation) Index 0 (Vehicle) 1066.55 (+/-215.04) na na 25 1315.78 (+/-458.20) 1.23 negative 50 1380.31 (+/-191.46) 1.29 negative 100 1505.94 (+/-584.74) 1.41 negative
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
Concentration (% v/v) Mean dpm/Animal Stimulation Result in acetone/olive oil 4:1 (Standard Deviation) Index 0 (Vehicle) 1066.55 (+/-215.04) na na 25 1315.78 (+/-458.20) 1.23 negative 50 1380.31 (+/-191.46) 1.29 negative 100 1505.94 (+/-584.74) 1.41 negative

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
The test item was considered to be a non-sensitiser under the conditions of the test, done according to guidline OECD 429.
Executive summary:

The test item was considered to be a non-sensitiser under the conditions of the test, done according to guidline OECD 429.