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EC number: 941-174-6 | CAS number: -
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- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 17th July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid GPMT conducted according to guideline is available, which is reliable without restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.
Test material
- Reference substance name:
- 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
- EC Number:
- 941-174-6
- IUPAC Name:
- 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
- Test material form:
- other: white solid wax
- Details on test material:
- - Name of test material: MDIPA-Esterquat C16-18 and C18 unsatd.
- Physical state: waxy solid
- Analytical purity: 100%
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: MDIPA-Esterquat C16-18 and C18 unsatd.
- Physical state: solid
- Analytical purity: 100%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’arbresle Cedex, France
- Age at study initiation: approx. 8 weeks
- Housing: Group housing of maximally 5 animals per labeled Noryl cage (Tecniplast; 74 cm x 54 cm x 25 cm height) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and shelters (CS3B02A Play tunnels (90 mm x 5 mm x 125 mm), Datesand, Manchester, UK) as cage enrichment
- Diet (e.g. ad libitum): Complete maintenance diet for guinea pigs (SSNIFF® Spezialdiäten GmbH, Soest, Germany) ad libitum; hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least twice a week
- Water (e.g. ad libitum): tap weater, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr ):approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Preliminary irritation study
Intradermal: 10, 5, 2, 1, 0.5, 0.2, 0.1, 0.05%
Epidermal: 50, 40, 30, 20, 10, 5, 2, 1%
Main study
Intradermal induction: 0.2%
Epidermal induction: 10%
Challenge: 1%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Preliminary irritation study
Intradermal: 10, 5, 2, 1, 0.5, 0.2, 0.1, 0.05%
Epidermal: 50, 40, 30, 20, 10, 5, 2, 1%
Main study
Intradermal induction: 0.2%
Epidermal induction: 10%
Challenge: 1%
- No. of animals per dose:
- Experimental group: 10 females
Control group: 5 females - Details on study design:
- RANGE FINDING TESTS:
A preliminary irritation study was conducted in order to select test substance concentrations to be used in the main Study. The selection of concentrations was based on the following criteria:
-The concentrations are well-tolerated systemically by the animals.
-For the induction exposures: the highest possible concentration that produced mild to moderate irritation (grades 2 - 3).
-For challenge exposure: the maximum non-irritant concentration.
Intradermal: 10, 5, 2, 1, 0.5, 0.2, 0.1, 0.05%
Epidermal: 50, 40, 30, 20, 10, 5, 2, 1%
Based on the results, the test substance concentrations selected for the main study were a 0.2% concentration for the intradermal induction and a 10% concentration for the epidermal induction exposure. A 1% test substance concentration was selected for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
intradermal
- Test groups:
A) A 1:1 w/w mixture of Freunds Complete Adjuvant with water for injection
B) The test substance at a 0.2% concentration
C) A 1:1 w/w mixture of the test substance, at twice the concentration used in (B) and Freunds Complete Adjuvant
- Control group: animals were treated as described for the experimental animals except that, instead of the test substance, vehicle alone was administered
- Site: scapular region
- Frequency of applications: 1x
epidermal
- No. of exposures: 1
- Exposure period: 48 h
- Test groups: 0.5 mL of a 10% test substance concentration
- Control group: 0.5 mL vehicle
- Site: scapular area
- Frequency of applications: 1x
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 24, 25
- Exposure period: 24 h
- Test groups: 0.1 mL 1% test substance, 0.1 mL vehicle
- Control group: 0.1 mL 1% test substance, 0.1 mL vehicle
- Site: flank
- Evaluation (hr after challenge): 24, 48 h - Positive control substance(s):
- yes
- Remarks:
- Alpha- Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- A reliability check with the positive control substance Alpha- Hexylcinnamaldehyde is carried out at regular intervals (last check Jan/Feb 2013) to check the sensitivity of the test system.
Concentrations selected for this study were:
Intradermal induction: A 20% solution in water (w/w).
Epidermal induction: undiluted.
Challenge: a 20% solution in water (w/w).
The positive control did induce skin sensitisation.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 20% Alpha- Hexylcinnamaldehyde
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Preliminary irritation study
SKIN REACTIONS AFTER INTRADERMAL INJECTION
Animal |
Conc % |
24 hours after injection |
48 hours after injection |
||
number |
|
Erythema |
Necrosis |
Erythema |
Necrosis |
|
|
(grade) |
(mm) |
(grade) |
(mm) |
48 |
10 |
|
5 |
|
6 |
|
5 |
|
4 |
|
5 |
49 |
2 |
|
3 |
|
4 |
|
1 |
|
2 |
|
3 |
45 |
0.5 |
3 |
|
|
1 |
|
0.2 |
2 |
|
1 |
|
50 |
0.1 |
2 |
|
1 |
|
|
0.05 |
1 |
|
1 |
|
SKIN REACTIONS AFTER EPIDERMAL EXPOSURE
Animal |
Conc. % |
24 hours after exposure |
48 hours after exposure |
||
number |
|
Erythema |
Oedema |
Erythema |
Oedema |
|
|
(grade) |
(grade) |
(grade) |
(grade) |
46 |
10 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
47 |
10 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
48 |
2 |
0 |
0 |
0 |
0 |
|
1 |
0 |
0 |
0 |
0 |
49 |
2 |
0 |
0 |
0 |
0 |
|
1 |
0 |
0 |
0 |
0 |
45 |
50 |
N |
1 |
N |
2 |
|
40 |
N |
1 |
N |
2 |
50 |
30 |
N |
1 |
N |
2 |
|
20 |
N |
0 |
N |
1 |
Main Study
Induction readings
Animal number |
Intradermal injection (Day 3) |
Epidermal exposure (Day 10) |
|
|||||||
|
A |
B |
D |
D |
|
|||||
Control group |
E |
N |
E |
N |
E |
N |
Erythema |
Oedema |
|
|
31 |
3 |
|
0 |
|
3 |
|
0 |
0 |
||
32 |
3 |
|
1 |
|
2 |
|
0 |
0 |
||
33 |
3 |
|
1 |
|
3 |
|
0 |
0 |
||
34 |
3 |
|
0 |
|
3 |
|
0 |
0 |
||
35 |
3 |
|
0 |
|
3 |
|
0 |
0 |
||
Experimental group |
E |
N |
E |
N |
E |
N |
|
|
||
36 |
3 |
|
2 |
|
3 |
|
3 |
0 |
||
37 |
3 |
|
3 |
|
3 |
|
3 |
0 |
||
38 |
3 |
|
2 |
|
2 |
|
3 |
0 |
||
39 |
3 |
|
2 |
|
3 |
|
3 |
0 |
||
40 |
3 |
|
3 |
|
3 |
|
3 |
0 |
||
41 |
3 |
|
3 |
|
3 |
|
3 |
0 |
||
42 |
3 |
|
3 |
|
3 |
|
3 |
0 |
||
43 |
3 |
|
3 |
|
3 |
|
3 |
0 |
||
44 |
3 |
|
3 |
|
3 |
|
3 |
0 |
||
45 |
3 |
|
3 |
|
3 |
|
3 |
0 |
||
A. 1:1 Mixture of Freund’s Complete Adjuvant and water for injection.
B. A 0.2% test substance concentration (Experimental); vehicle (Control).
C. 1:1 Mixture of Freund’s Complete Adjuvant and a 0.4% concentration (Experimental) or vehicle (Control).
D. A 10% test substance concentration (Experimental); vehicle (Control).
Skin effects intradermal injections:
E. Erythema (grade)
N. Signs of necrosis (mm in diameter)
Challenge readings
Animal number |
DAY 24 |
DAY 25 |
||
|
1%# |
Vehicle* |
1%# |
Vehicle* |
Control group |
||||
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
Experimental group |
||||
36 |
0 |
0 |
0 |
0 |
37 |
0 |
0 |
0 |
0 |
38 |
0 |
0 |
0 |
0 |
39 |
0 |
0 |
0 |
0 |
40 |
0 |
0 |
0 |
0 |
41 |
0 |
0 |
0 |
0 |
42 |
0 |
0 |
1p |
0 |
43 |
0 |
0 |
0 |
0 |
44 |
0 |
0 |
0p |
0 |
51 |
0 |
0 |
0 |
0 |
#. Test substance concentration.
*. Water (Elix)
p. Scaliness
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this Guinea Pig Maximisation Test, MDIPA-Esterquat C16-18 and C18 unsatd. was not sensitising.
- Executive summary:
In a dermal sensitisation study according to OECD Guideline 406 (adopted 17th July 1992) and EU method B.6 (May 2008) with MDIPA-Esterquat C16-18 and C18 unsatd. (100% a.i.) in water, young adult female Dunkin-Hartley guinea pigs (10 in test group, 5 in control group) were tested using the method of Magnusson and Kligman. Alpha-Hexylcinnamaldehyde was used as positive control.
Based on the results of a preliminary study, the test substance concentrations selected for the main study were a 0.2% concentration for the intradermal induction and a 10% concentration for the epidermal induction exposure. A 1% test substance concentration was selected for the challenge phase.
After epidermal induction all animals of the experimental group showed signs of irritation. Following a challenge exposure to a 1% test substance concentration, one experimental animal showed discrete or patchy erythema, with scaliness, and one experimental animal showed scaliness only, both at 48 hours after exposure. No skin reactions were evident in the control animals and all other experimental animals. The sensitisation rate was 10%.
According to CLP, EU GHS (Regulation (EC) No 1272/2008), a response of at least 30% of the test animals of an adjuvant type guinea pig test method for skin sensitisation is considered as positive.
MDIPA-Esterquat C16-18 and C18 unsatd. is not a dermal sensitiser in this study.
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