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EC number: 250-830-4 | CAS number: 31837-42-0
Endpoint summary
Administrative data
Description of key information
In the study the test item suspended in DMSO was assessed for itspossible contact allergenic potential.
For this purpose a local lymph node assay (LLNA) was performed using test item concentrationsof 3.75 %, 7.0 %, and 15.0 % (w/v).
The animals did not show any clinical signs during the course of the study and no cases ofmortality were observed.
In this study Stimulation Indices (S.I.) of 1.4, 1.3, and 1.6 were determined with the testitem at concentrations of 3.75 %, 7.0 %, and 15.0 % (w/v) in DMSO.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 11 OCT 2004 to 10 Nov 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 429)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV, Horst, The Netherlands
- Age at study initiation: 8-12 weeks
- Housing: Individually in Macrolon Type I cages with wire mesh top and granulated sooft wood bedding
- Diet: Pelleted standard diet (provided by Harlan Winkelmann GmbH, Borchen, Germany); ad libitum
- Water: Community tap water from Rossdorf, ad libitum
- Acclimation period: yes, but duration not mentioned
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0, 3.75, 7, and 15% (w/v)
- No. of animals per dose:
- 5 females per dose group
2 females in the pre-test - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: DMSO was selected because in any other vehicle test item concentrations above 15% could not be obtained or due to the instability of the test item withinh the vehicle
- 15% (w/v) was the highest technically applicable concentration
- Irritation: no systemic toxicity after single application of test item concentrations up to 15% (w/v); irritating effects could not be assessed due to yellow staining at concentration of 15% (w/v), but no ear swelling was observed
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
1: exposure to at least one concentration of the test item resulted in an incorporation of 3H-methyl thymidine at least 3-fold or greater than that recorded in control mice as indicated by the stimulation index
2: data are compatible with a conventional dose response, although allowance must be made for either local toxicity or immunological suppression
TREATMENT PREPARATION AND ADMINISTRATION:
- individual preparation of weight volume dilutions using a magnetic stirrer as homogenizer
- test item preparations were made feshly before each dosing occasion
- 25 µl were spread over the entire dorsal surface of each ear lobe once daily for three consecutive days - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- - calculations of mean values and standard deviations for body weight
- A statistical analysis was conducted for assessment of the dose-response relationship, and the EC3 value was calculated according to the equation EC3 = (a-c) [(3-d)/(b-d)] + c; where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining Iymph node cell proliferative activity; (a, b) and (c, d) are respectively the co-ordinates of the two pair of data lying immediately above and below the value of 3 an the local lymph node assay dose response Plot.
- The Dunnett-test (ANOVA) was conducted to assess whether the difference is statistically significant between test item groups and negative control (vehicle) group. Statistical significance was at the five per cent level (p < 0.05). - Positive control results:
- Stimulation indices of 1.96, 3.03 and 4.92 were determined with the positive control item at concentrations of 5%, 10% and 25% (w/v), respectively, in acetone:olive oil, 4:1 (v/v). An EC3 value was calculated (= 9.9% (w/v)).
- Key result
- Parameter:
- SI
- Value:
- >= 1.4 - <= 1.6
- Test group / Remarks:
- all
- Remarks on result:
- other: Stimulation indices (SI) were all below 3. The following SI were calculated: 3.75% test item: 1.4 7% test item: 1.3 15% test item: 1.6
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM/lymph node Background of measurement: 0 - 3.4; mean: 1.7 (was taken for calculations) control group: 613.4 3.75% test item: 868.4 7% test item: 872.1 15% test item: 1026.9
- Interpretation of results:
- not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Tested in this study according to OECD test guideline no. 429 and GLP conditions the test item was not a skin sensitizer.
- Executive summary:
In the study the test item suspended in DMSO was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay (LLNA) was performed using test item concentrationsof 3.75 %, 7.0 %, and 15.0 % (w/v).
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (S.I.) of 1.4, 1.3, and 1.6 were determined with the test item at concentrations of 3.75 %, 7.0 %, and 15.0 % (w/v) in DMSO.
The test item was found to be not a skin sensitiser in this assay.
- 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:
- From 11 OCT 2004 to 10 Nov 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 429)
- Justification for type of information:
- See read across document in chapter 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
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV, Horst, The Netherlands
- Age at study initiation: 8-12 weeks
- Housing: Individually in Macrolon Type I cages with wire mesh top and granulated sooft wood bedding
- Diet: Pelleted standard diet (provided by Harlan Winkelmann GmbH, Borchen, Germany); ad libitum
- Water: Community tap water from Rossdorf, ad libitum
- Acclimation period: yes, but duration not mentioned
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0, 3.75, 7, and 15% (w/v)
- No. of animals per dose:
- 5 females per dose group
2 females in the pre-test - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: DMSO was selected because in any other vehicle test item concentrations above 15% could not be obtained or due to the instability of the test item withinh the vehicle
- 15% (w/v) was the highest technically applicable concentration
- Irritation: no systemic toxicity after single application of test item concentrations up to 15% (w/v); irritating effects could not be assessed due to yellow staining at concentration of 15% (w/v), but no ear swelling was observed
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
1: exposure to at least one concentration of the test item resulted in an incorporation of 3H-methyl thymidine at least 3-fold or greater than that recorded in control mice as indicated by the stimulation index
2: data are compatible with a conventional dose response, although allowance must be made for either local toxicity or immunological suppression
TREATMENT PREPARATION AND ADMINISTRATION:
- individual preparation of weight volume dilutions using a magnetic stirrer as homogenizer
- test item preparations were made feshly before each dosing occasion
- 25 µl were spread over the entire dorsal surface of each ear lobe once daily for three consecutive days - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- - calculations of mean values and standard deviations for body weight
- A statistical analysis was conducted for assessment of the dose-response relationship, and the EC3 value was calculated according to the equation EC3 = (a-c) [(3-d)/(b-d)] + c; where EC3 is the estimated concentration of the test item required to produce a 3-fold increase in draining Iymph node cell proliferative activity; (a, b) and (c, d) are respectively the co-ordinates of the two pair of data lying immediately above and below the value of 3 an the local lymph node assay dose response Plot.
- The Dunnett-test (ANOVA) was conducted to assess whether the difference is statistically significant between test item groups and negative control (vehicle) group. Statistical significance was at the five per cent level (p < 0.05). - Positive control results:
- Stimulation indices of 1.96, 3.03 and 4.92 were determined with the positive control item at concentrations of 5%, 10% and 25% (w/v), respectively, in acetone:olive oil, 4:1 (v/v). An EC3 value was calculated (= 9.9% (w/v)).
- Key result
- Parameter:
- SI
- Value:
- >= 1.4 - <= 1.6
- Test group / Remarks:
- all
- Remarks on result:
- other: Stimulation indices (SI) were all below 3. The following SI were calculated: 3.75% test item: 1.4 7% test item: 1.3 15% test item: 1.6
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM/lymph node Background of measurement: 0 - 3.4; mean: 1.7 (was taken for calculations) control group: 613.4 3.75% test item: 868.4 7% test item: 872.1 15% test item: 1026.9
- Interpretation of results:
- not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Tested in this study according to OECD test guideline no. 429 and GLP conditions the test item was not a skin sensitizer.
- Executive summary:
In the study the test item suspended in DMSO was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay (LLNA) was performed using test item concentrationsof 3.75 %, 7.0 %, and 15.0 % (w/v).
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (S.I.) of 1.4, 1.3, and 1.6 were determined with the test item at concentrations of 3.75 %, 7.0 %, and 15.0 % (w/v) in DMSO.
The test item was found to be not a skin sensitiser in this assay.
- Endpoint:
- skin sensitisation: in chemico
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. Calculation of the EC3 value was not performed because no test concentration produced a SI of 3 or higher.
Test item |
Measurement |
Calculation |
Result |
Calculation |
DPM |
Result |
|
% (w/v) |
Group |
DPM-BG per animal |
S.I. * |
number |
S.1 |
||
- |
BG I |
3.4 |
|
--- |
|
|
-- |
|
BG II |
0,0 |
--- --- |
--- |
- |
-- |
-- |
|
CG 1_1 |
891.4 |
889,7 |
|
|
|
--- |
- |
CG 1_2 |
980.9 |
979.2 |
--- |
-- |
|
|
|
CG 1_3 |
1392.9 |
1391.2 |
|
--- |
--- |
-- |
--- |
CG 1_4 |
1378.5 |
1376,8 |
|
- |
- |
|
|
CG 1_5 |
1679.0 |
1677.3 |
|
10 |
631.4 |
1.0 |
3.75 |
TG 2_1 |
2339.5 |
2337.8 |
1,9 |
|
|
|
3.75 |
TG 2_2 |
1481.9 |
1480.2 |
1,2 |
|
|
-- |
3.75 |
TG 2_3 |
1498.5 |
1496.8 |
1.2 |
|
|
-- |
3.75 |
TG 2_4 |
1743.1 |
1741.4 |
1.4 |
--- |
- |
-- |
3.75 |
TG 2_5 |
1629.6 |
1627.9 |
1.3 |
10 |
868.4 |
1.4 |
7.0 |
TG 3_1 |
1140.0 |
1138.3 |
0.9 |
|
|
-- |
7.0 |
TG 3_2 |
1822.8 |
1821.1 |
1.4 |
|
--- |
|
7.0 |
TG 3_3 |
1665.0 |
1663.3 |
1.3 |
--- |
|
|
7.0 |
TG 3_4 |
2168.6 |
2166.9 |
1.7 |
--- |
--- |
-- |
7.0 |
TG 3_5 |
1483.4 |
1481.7 |
1.2 |
10 |
827.1 |
1.3 |
15.0 |
TG 41 |
2075.9 |
2074.2 |
1.6 |
|
|
-- |
15.0 |
TG 4_2 |
1870.6 |
1868.9 |
1.5 |
--- |
- |
|
15.0 |
TG 4_3 |
2893.5 |
2891.8 |
2,3 |
|
|
|
15.0 |
TG 4_4 |
1936.7 |
1935.0 |
1.5 |
|
||
15.0 |
TG 4_5 |
1501.0 |
1499.3 |
1.2 |
10 |
1026.9 |
1.6 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
CG = Control Group
TG = Test Group
S.l. = Stimulation Index
* = mean net DPM value per lymph node of the mouse divided by the mean net DPMvalueof the vehiclecontrol group
a) = The mean of the background value (BGI and BGH) was subtracted from the value.
b) = DPM/node
was determined by dividing the sum of the measured values from all lymph
nodes within a
group
by the number of lymph nodes taken from that group
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. Calculation of the EC3 value was not performed because no test concentration produced a SI of 3 or higher.
Test item |
Measurement |
Calculation |
Result |
Calculation |
DPM |
Result |
|
% (w/v) |
Group |
DPM-BG per animal |
S.I. * |
number |
S.1 |
||
- |
BG I |
3.4 |
|
--- |
|
|
-- |
|
BG II |
0,0 |
--- --- |
--- |
- |
-- |
-- |
|
CG 1_1 |
891.4 |
889,7 |
|
|
|
--- |
- |
CG 1_2 |
980.9 |
979.2 |
--- |
-- |
|
|
|
CG 1_3 |
1392.9 |
1391.2 |
|
--- |
--- |
-- |
--- |
CG 1_4 |
1378.5 |
1376,8 |
|
- |
- |
|
|
CG 1_5 |
1679.0 |
1677.3 |
|
10 |
631.4 |
1.0 |
3.75 |
TG 2_1 |
2339.5 |
2337.8 |
1,9 |
|
|
|
3.75 |
TG 2_2 |
1481.9 |
1480.2 |
1,2 |
|
|
-- |
3.75 |
TG 2_3 |
1498.5 |
1496.8 |
1.2 |
|
|
-- |
3.75 |
TG 2_4 |
1743.1 |
1741.4 |
1.4 |
--- |
- |
-- |
3.75 |
TG 2_5 |
1629.6 |
1627.9 |
1.3 |
10 |
868.4 |
1.4 |
7.0 |
TG 3_1 |
1140.0 |
1138.3 |
0.9 |
|
|
-- |
7.0 |
TG 3_2 |
1822.8 |
1821.1 |
1.4 |
|
--- |
|
7.0 |
TG 3_3 |
1665.0 |
1663.3 |
1.3 |
--- |
|
|
7.0 |
TG 3_4 |
2168.6 |
2166.9 |
1.7 |
--- |
--- |
-- |
7.0 |
TG 3_5 |
1483.4 |
1481.7 |
1.2 |
10 |
827.1 |
1.3 |
15.0 |
TG 41 |
2075.9 |
2074.2 |
1.6 |
|
|
-- |
15.0 |
TG 4_2 |
1870.6 |
1868.9 |
1.5 |
--- |
- |
|
15.0 |
TG 4_3 |
2893.5 |
2891.8 |
2,3 |
|
|
|
15.0 |
TG 4_4 |
1936.7 |
1935.0 |
1.5 |
|
||
15.0 |
TG 4_5 |
1501.0 |
1499.3 |
1.2 |
10 |
1026.9 |
1.6 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
CG = Control Group
TG = Test Group
S.l. = Stimulation Index
* = mean net DPM value per lymph node of the mouse divided by the mean net DPMvalueof the vehiclecontrol group
a) = The mean of the background value (BGI and BGH) was subtracted from the value.
b) = DPM/node
was determined by dividing the sum of the measured values from all lymph
nodes within a
group
by the number of lymph nodes taken from that group
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No classification
The test item did not cause sensitising effects in an LLNA.
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