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Diss Factsheets

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:
2012-10-25 to 2013-01-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed under GLP regulations according to OECD TG 429.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
butyl 4-hydroxycyclohexanecarboxylate
EC Number:
941-637-2
Cas Number:
1384257-92-4
Molecular formula:
C11H20O3
IUPAC Name:
butyl 4-hydroxycyclohexanecarboxylate
Test material form:
other: liquid

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories B.V., Venray, Netherlands
- Age at beginning of treatment: 8- 11 weeks
- Body weight at beginning of treatment: 18.3 - 25.5 g
- Housing: group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:6 days prior start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9 - 20.6°C
- Humidity (%): 36.8 - 55.7%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25%
50%
100%
No. of animals per dose:
Control group: 4/group
test item groups: 4/group
Details on study design:
The study was performed according to OECD TG 429 (radioactive method).
The test item concentrations for the main study were established based on the results of a pre-test including ear thickness measurement using 2 mice. The radioactivity of the pooled lymph nodes were analyzed to investigate the skin sensitising potential of the test item.


Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Value:
2.1
Test group / Remarks:
25%
Parameter:
SI
Value:
1.4
Test group / Remarks:
50%
Parameter:
SI
Value:
1.9
Test group / Remarks:
100%

Any other information on results incl. tables

Study Design

In order to study a possible skin sensitising potential of the test item CX-3, three groups each of four female mice were treated once daily with the test item at concentrations of 25, 50, (w/v) in acetone:olive oil (4:1, v/v) and 100% by topical application to the dorsum of each ear for three consecutive days. A control group of four mice was treated with the vehicle only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of 3H-methyl thymidine measured in a beta-scintillation counter.

Results

All treated animals survived the scheduled study period. Neither clinical signs on the ears of the animals nor systemic findings were observed during the study period. The results obtained (Stimulation Index, SI) are reported in the following table.
   Test item conc [%] S.I. 
 Group 2  25  2.1
 Group 3  50  1.4
 Group 3  100 1.9 

A dose-response relationship was not observed. A calculation of the EC3 value was not performed as no test item concentration produced a S.I. of 3 or higher.

Conclusion

The test item is not a skin sensitiser under the conditions of this study.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not a skin sensitiser under the test conditions of this study and thus no classification for skin sensitisation is needed according to CLP-Regulation (EC) No 1272/2008.
Executive summary:
see above