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EC number: 701-236-3 | CAS number: -
- Life Cycle description
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Exposure related observations in humans
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- Additional toxicological data
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 17 May 2010 and 02 June 2010.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- The study was performed between 17 May 2010 and 02 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: See ''Remak''
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13
- Reason / purpose for cross-reference:
- read-across source
- 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)
- Species:
- mouse
- Strain:
- other: CBA/Ca (CBA/CaOlaHsd)
- Sex:
- female
- Vehicle:
- other: Ethanol/distilled water 7:3. Please see below for Vehicle Determination Record
- Concentration:
- Each group was exposed to the test material at concentrations of 10%, 5% or 2.5% w/w in ethanol/dist illed water 7:3.
- No. of animals per dose:
- Groups of four mice were treated
- Positive control results:
- One group of five animals was treated with 50 µl (25 µl per ear) of alpha-Hexylcinnamaldehyde, Tech, 85% as a solution in ethanol/distilled water 7:3 at a concentration of 15% v/v. A further control group of five animals was treated with ethanol/distilled water 7:3 alone.
The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration % v/v in ethanol/distilled water 7:3 Stimulation Index (SI) Result 15 9.61 Positive
Alpha-Hexylcinnamaldehyde, Tech 85% was considered to be a sensitiser under the conditions of the test. - Parameter:
- SI
- Remarks on result:
- other: A stimulation index of less than 3 was recorded for the undiluted test material and the test material at concentrations of 10%, 5% and 2.5% w/w in ethanol/distilled water 7:3. The stimulation index (SI) results are given in Table 2.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: other: The radioactive disintegrations per minute (dpm) per lymph node and the stimulation index (SI) are given in Table 2.
- Interpretation of results:
- other: Not sensitising
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test.
- 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)
Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Directive 2004/73/EC
Methods.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 10% w/w, 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 (25 µl per ear) of the test material as asolutioninethanol/distilled water 7:3at concentrations of10%,5% or 2.5% w/w. A further group of four animals was treated withethanol/distilled water 7:3alone.
Results.
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 (%w/w) in ethanol/ distilled water 7:3
Stimulation Index
Result
2.5
0.86
Negative
5
1.48
Negative
10
1.68
Negative
Conclusion.
The test material was considered to be a non-sensitiser under the conditions of the test.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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
- Reference substance name:
- Fatty acids C18-(unsaturated) lithium salts
- EC Number:
- 700-426-3
- Cas Number:
- 502962-81-4
- Molecular formula:
- Since this is a complex mixture of constituents no single formula can be assigned
- IUPAC Name:
- Fatty acids C18-(unsaturated) lithium salts
- Details on test material:
- Sponsor's identification : Fatty acids C18-(unsaturated) lithium salts
Description : off white solid
Batch number : SF 173
Date received : 21 January 2010
Expiry date : 21 January 2012
Storage conditions : room temperature in the dark
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:
Female CBA/Ca (CBA/CaOlaHsd) strain mice were supplied by Harlan UK Limited, Oxon, UK.
- Age at study initiation:
At the start of the study the animals were eight to twelve weeks old.
- Weight at study initiation:
At the start of the study the animals were in the weight range of 15 to 23g.
- Housing:
The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum):
ad libitum (2014 Teklad Global Rodent diet supplied by Harlan UK Limited, Oxon, UK)
- Water (e.g. ad libitum):
ad libitum.
- Acclimation period:
At least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
The temperature was controlled to remain within the target ranges of 19 to 25 deg C.
- Humidity (%):
The humidity was controlled to remain within the target ranges of 30 to 70%.
- Air changes (per hr):
The rate of air exchange was approximately fifteen changes per hour.
- Photoperiod (hrs dark / hrs light):
The lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
IN-LIFE DATES:
From: Day 1 To: Day 6
Study design: in vivo (LLNA)
- Vehicle:
- other: Ethanol/distilled water 7:3. Please see below for Vehicle Determination Record
- Concentration:
- Each group was exposed to the test material at concentrations of 10%, 5% or 2.5% w/w in ethanol/distilled water 7:3.
- No. of animals per dose:
- Groups of four mice were treated
- Details on study design:
- RANGE FINDING TESTS:
Using available information regarding the systemic toxicity/irritancy potential of the test material, a preliminary screening test was performed using
one mouse. The mouse was treated by daily application of 25 µl of 10% w/w in ethanol/distilled water 7:3 to the dorsal surface of each ear for three
consecutive days (Days 1, 2, 3). The mouse was observed twice daily on Days 1, 2 and 3 and once daily on Days 4, 5 and 6. Any signs of toxicity or
excessive local irritation noted during this period were recorded. The bodyweight was recorded on Day 1 (prior to dosing) and on Day 6.
- Lymph node proliferation response:
Clinical observations, bodyweight and mortality data are give in the results section (table 1).
No signs of systemic toxicity were noted.
Based on this information the dose levels selected for the main test were 10%, 5% or 2.5% w/w in ethanol/distilled water 7:3.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
Local Lymph Node Assay in the Mouse. The assay has undergone extensive inter-laboratory validation and has been shown to reliably detect test
materials that are moderate to strong sensitisers.
- Criteria used to consider a positive response:
The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node(dpm/node)
and as the ratio of 3HTdR incorporation in lymph node cells of test nodes relative to that recorded for the control nodes (stimulation Index).
The test material will be regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test material failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non-sensitier".
TREATMENT PREPARATION AND ADMINISTRATION:
For the purpose of the study, the test material was used at concentrations of 10%, 5% or 2.5% w/w in ethanol/distilled water 7:3. This vehicle was
chosen as it produced the most suitable formulation at the required concentration.
Determination, by analysis, of the concentration, homogeneity and stability of the test material preparations was not appropriate because it was not
specified in the Study Plan and is not a requirement of the Test Guidelines.
The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest
suitable concentration. The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface
of each ear for three consecutive days (Days 1, 2 and 3). 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.
3H-Methyl Thymidine Administration:
Five days following the first topical application of the test material (Day 6) all mice were injected via the tail vein with 250 µl of phosphate buffered
saline (PBS) containing 3H-methyl thymidine (3HTdR: 80 µCi/ml, specific activity 2.0 Ci/mmol, GE Healthcare UK Ltd) giving a total of 20 µCi to each mouse. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- None provided.
Results and discussion
- Positive control results:
- One group of five animals was treated with 50 µl (25 µl per ear) of alpha-Hexylcinnamaldehyde, Tech, 85% as a solution in ethanol/distilled water 7:3
at a concentration of 15% v/v. A further control group of five animals was treated with ethanol/distilled water 7:3 alone.
The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration % v/v in ethanol/distilled water 7:3 Stimulation Index (SI) Result
15 9.61 Positive
Alpha-Hexylcinnamaldehyde, Tech 85% was considered to be a sensitiser under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: A stimulation index of less than 3 was recorded for the undiluted test material and the test material at concentrations of 10%, 5% and 2.5% w/w in ethanol/distilled water 7:3. The stimulation index (SI) results are given in Table 2.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The radioactive disintegrations per minute (dpm) per lymph node and the stimulation index (SI) are given in Table 2.
Any other information on results incl. tables
Table 1 Clinical Observations, Bodyweight and Mortality Data – Preliminary Screening Test
Concentration (%w/w) in |
Animal Number |
Bodyweight (g) |
Day |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Day 1 |
Day 6 |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
|||||
10 |
S-1 |
18 |
18 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Table 2 Disintegrations per Minute, Disintegrations per Minute/Node and Stimulation Index
Concentration |
dpm |
dpm/Nodea |
Stimulation Indexb |
Result |
Vehicle |
6537.75 |
817.22 |
na |
na |
2.5 |
5605.01 |
700.63 |
0.86 |
Negative |
5 |
9657.33 |
1207.17 |
1.48 |
Negative |
10 |
10966.24 |
1370.78 |
1.68 |
Negative |
dpm= Disintegrations per minut
a= Disintegrations per minute/node obtained by dividing the disintegrations per minute value by 8 (total number of lymph nodes)
b= Stimulation Index of 3.0 or greater indicates a positive result
na = Not applicable
Table 3 Individual Clinical Observations and Mortality Data
Concentration |
Animal Number |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
|||
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
Pre-Dose |
Post Dose |
|||||
Vehicle |
1-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2.5 |
2-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
3-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
10 |
4-1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4-2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4-4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Table 4 Individual Bodyweights and Bodyweight Changes
Concentration |
Animal Number |
Bodyweight (g) |
Bodyweight Change (g) |
|
Day 1 |
Day 6 |
|||
Vehicle |
1-1 |
19 |
19 |
0 |
1-2 |
17 |
17 |
0 |
|
1-3 |
19 |
22 |
3 |
|
1-4 |
22 |
25 |
3 |
|
2.5 |
2-1 |
21 |
21 |
0 |
2-2 |
21 |
20 |
-1 |
|
2-3 |
19 |
19 |
0 |
|
2-4 |
20 |
20 |
0 |
|
5 |
3-1 |
19 |
20 |
1 |
3-2 |
20 |
20 |
0 |
|
3-3 |
19 |
19 |
0 |
|
3-4 |
22 |
22 |
0 |
|
10 |
4-1 |
21 |
20 |
-1 |
4-2 |
19 |
19 |
0 |
|
4-3 |
18 |
19 |
1 |
|
4-4 |
19 |
19 |
0 |
Current Positive Control Study for the Local Lymph Node Assay
Introduction.
A study was performed to assess the sensitivity of the strain of mouse used at these laboratories to a known sensitiser. The methodology for the LLNA is detailed in the OECD Guideline for the Testing of Chemicals, No. 429, and Method B.42 of CommissionRegulation (EC) No. 440/2008. The study described in this document is based on these test methods but has been refined in order to reduce the number of animals required. The reduced LLNA (rLLNA) has been endorsed by the non-Commission members of the European Centre for the Validation of Alternative Methods (ECVAM) Scientific Advisory Committee (ESAC) at its 26thmeeting held on 26 – 27 April 2007 at ECVAM, Ispra, Italy.
Test Material : α-Hexylcinnamaldehyde, tech., 85%
Project number : 0039/1138
Study dates : 12 February 2010 to 18 February 2010
Methods.
A group of five animals was treated with 50 µl (25 µl per ear) of α-Hexylcinnamaldehyde, tech., 85%as a solution in ethanol/distilled water 7:3 at a concentration of 15% v/v. A further control group of five animals was treated with ethanol/distilled water 7:3 alone.
Results.
The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group is as follows:
Concentration (% v/v) in 7:3 |
Stimulation Index |
Result |
15 |
9.61 |
Positive |
Conclusion.
α-Hexylcinnamaldehyde, tech., 85%was considered to be a sensitiser under the conditions of the test.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test.
- 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)
Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Directive 2004/73/EC
Methods.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 10% w/w, 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 (25 µl per ear) of the test material as asolutioninethanol/distilled water 7:3at concentrations of10%,5% or 2.5% w/w. A further group of four animals was treated withethanol/distilled water 7:3alone.
Results.
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 (%w/w) in
ethanol/distilled water 7:3Stimulation Index
Result
2.5
0.86
Negative
5
1.48
Negative
10
1.68
Negative
Conclusion.
The test material was considered to be a non-sensitiser under the conditions of the test.
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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