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Skin sensitisation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- June 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaOlaHsd)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): ad libitum access to 2014 Teklad Global Rodent diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 degrees C
- Humidity (%): 30-70%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs light / 12 hours dark
Study design: in vivo (LLNA)
- Vehicle:
- other: butanone
- Concentration:
- 100%, 50% or 25% v/v in butanone
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: undiluted test substance used
- Irritation: no signs of systemic toxicity or skin irritation were noted
- Lymph node proliferation response: not measured
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: at least a threefold increase in 3HTdR incorporation compared to control values
TREATMENT PREPARATION AND ADMINISTRATION: test material was diluted in butanone and applied to the dorsal surface of each ear of the mice for three consecutive days with a three day observation period. The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The EC3 value (concentration of test material expected to cause a 3-fold increase in 3HTdR incorporation) was calculated using the following equation: EC3 = c + [[(3-d)/(b-d)] x (a-c)], where a = lowest concentration giving stimulation index >3, b = actual stimulation index caused by 'a', c = highest concentration failing to produce a stimulation index of 3, and d = actual stimulation index caused by 'c'.
Results and discussion
- Positive control results:
- A group of 5 animals treated with 25 ul per ear of alpha-Hexylcinnamaldehyde as a solution in butanone as a concentration of 15% v/v produced a stimulation index of 6.63.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 2.04
- Test group / Remarks:
- 25 % w/v
- Parameter:
- SI
- Value:
- 3.85
- Test group / Remarks:
- 50 % w/v
- Parameter:
- SI
- Value:
- 3.27
- Test group / Remarks:
- 100 % w/v
- Parameter:
- EC3
- Value:
- 38.3
Any other information on results incl. tables
There were no deaths, signs of systemic toxicity or skin irritation noted in the test or control animals during the test.
EC3 = 38.3 % test material v/v in butanone
Table: Disintegrations per Minute (dpm), Disintegrations per Minute/Node and Stimulation Index
Concentration (%v/v) in butanone |
Dpm |
Dpm/Node |
Stimulation Index |
Result |
Vehicle |
4831.66 |
603.96 |
Not applicable |
Not applicable |
25 |
9858.69 |
1232.34 |
2.04 |
Negative |
50 |
18591.17 |
2323.90 |
3.85 |
Positive |
100 |
15820.51 |
1977.56 |
3.27 |
Positive |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as a skin sensitiser
- Conclusions:
- Given additional information provided in the attached document, the weakly positive responses in the LLNA should not result in a label of skin sensitization.
- Executive summary:
A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following:
- OECD Guideline for the Testing of Chemicals No. 429 “Skin Sensitisation: Local Lymph Node Assay” (adopted 24 April 2002)
- Method B.42 Skin Sensitisation (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100 %, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µl (25µl per ear) of the undiluted test material or the test material as a solution in butanone at concentrations of 50% or 25% v/v. A further group of four animals was treated with butanone alone.
The stimulation index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration (% v/v) in butanone
Stimulation Index
Result
25
2.04
Negative
50
3.85
Positive
100
3.27
Positive
The concentration of test material expected to cause a 3-fold increase in3HTdR incorporation (EC3) value) was calculated to be 38.3% v/v in butanone.
The test material was considered to be a sensitiser under the conditions of the test. However, given additional information provided in the attachment, the weakly positive responses in the LLNA should not result in a label of skin sensitization.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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