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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study according to OECD guideline 429 (Skin sensitisation: Local Lymph Node Assay)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
one dead animal in the vehicle group on theday of preparation
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The pure active substance was used.
Purity: 99%
Batch number: Catena-08-183
Production date: 16.05.2008
Expiry date: 05.2009
Storage: Closed vessel at room temperature in the dark

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Test system: Mice, CBA/CaOlaHsd
Source: Harlan Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst / The Netherlands
Age: 8 - 12 weeks (beginning of treatment)
Body weight: 18.8 - 23.6 g
Identification: Single caging. The animals were distributed into the test groups at random and identified by cage number.
Acclimatisation: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible
signs of illness were used for the study.

Study design: in vivo (LLNA)

Vehicle:
other: ethanol:deionised water (7+3)
Concentration:
10, 25, 50%
No. of animals per dose:
5
Details on study design:
Number of animals for the pre-test: 2 females
Number of animals for the main study: 20 females
Number of animals per group: 5 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Statistics:
The mean values and standard deviations were calculated for the body weight in the groups.

Results and discussion

Positive control results:
concentration SI
5% 1.78
10% 1.84
25% 4.87

EC3: 15.7%

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Test substance 10%: 1.05 Test substance 25%: 0.85 Test substance 50%: 0.74
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Background I: 23 Background II: 24 Control group: 3243 Test substance 10%: 4244 Test substance 25%: 3462 Test substance 50%: 3003

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The substance is not a skin sensitiser.
Executive summary:

In the study the test substance dissolved in ethanol:deionised water (7+3) was assessed for its possible contact allergenic potential.

For this purpose a local lymph node assay was performed using test item concentrations of 10, 25, and 50 %.

The animals did not show any clinical signs during the course of the study and no cases of local irritation or test item related mortality were observed. One animal of the vehicle control group (animal 1) was found dead on the day of preparation.

In this study Stimulation Indices (S.I.) of 1.05, 0.85, and 0.74 were determined with the test item at concentrations of 10, 25, and 50 % in ethanol:deionised water (7+3), respectively.

The test item TEAP was not a skin sensitiser in this assay.