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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2010
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)
Species:
mouse
Strain:
CBA/Ca
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ENVIGO, San Pietro al Natisone, Italy
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF at arrival, standard hausing during the study
- Age at study initiation: 12 weeks
- Weight at study initiation: 20.1-21.9 g
- Housing: group housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum) : ad libitum
- Acclimation period: 35 days
- Indication of any skin lesions:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-25.7
- Humidity (%):27-80
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: To:
Vehicle:
methyl ethyl ketone
Concentration:
5, 2.5, 1, and 0.5%
No. of animals per dose:
4
Details on study design:
PRE-SCREEN TESTS:
- Compound solubility: methylethylketone proved to be a suitable solvent
- Irritation: yes (at concentrations >= 5%)
- Systemic toxicity: yes (at concentrations >= 5%)
- Ear thickness measurements: yes
- Erythema scores: yes

Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)
Positive control results:
the stimulation index of 8.8 at 25% hexyl cinnamic aldehyde was in line with historical control data.
Key result
Parameter:
SI
Value:
4.8
Test group / Remarks:
5%
Key result
Parameter:
SI
Value:
4.4
Test group / Remarks:
2.5%
Key result
Parameter:
SI
Value:
3.5
Test group / Remarks:
1%
Parameter:
SI
Value:
3.9
Test group / Remarks:
0.5%
Cellular proliferation data / Observations:
see copies of tables on body weights, on DPM and calculated stimulation index attached in background material
Interpretation of results:
other: skin sensitising potential
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In the Local Lymph Node Assay the substance induced proliferation of lymph node cells. The concentration inducing a stimulation index of 3 was clearly below 2%. Accordingly, the substance is classifed for skin sensitisation in category 1A according to Regulation 1272/2008.