Registration Dossier

Diss Factsheets

Administrative data

Description of key information

According to “Guidance on information requirements and chemical safety assessment Chapter R.7.3.4.2” reliable and relevant human data should be used for hazard identification and are even preferable to animal data. The human repeat insult patch test (HRIPT) is considered to be a good predictor for the sensitisation potential (Bannan et al 1991).
Data from three Human Repeat Insult Patch Tests including a total of 283 evaluated volunteers were available. Studies are well documented and performed in accordance with ethical considerations.
Throughout the HRIPT studies, the observed irritation scores of 1 and 2 (of an overall scale of up to 6) were judged to be acceptable due to the nine extended exposures of 24 hours and due to the occlusive dressing. Edema, which would be indicative for a sensitising reaction was not observed in any of the challenged volunteers.
Likewise, no sensitisation was observed in the two supporting Bühler studies, in which the concentrations used for induction failed to induce any irritation (contrary to what is recommended by the guideline).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1986-02-04 to 1986-03-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Concentration used for induction was not the highest to cause mild irritation as postulated by the OECD guideline 406.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A valid Buehler test conducted according to guideline with acceptable restrictions is available, which is reliable with 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.
Specific details on test material used for the study:
- Diethylester dimethyl ammonium chloride
- Physical state: solid
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH & Co.
- Age at study initiation: Not available
- Weight at study initiation: 340 grams (estimated)
- Housing: 5 animals in macrolon plastic cages IV (20 cm high, 33 cm width, 55 cm length)
- Diet (e.g. ad libitum): ad libitum Ssniff -G
- Water (e.g. ad libitum):ad libitum,Aqua fontana as for human consumption
- Acclimation period: at least 4 days instead of 5 days recommended by the OECD guideline 406


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2 °C
- Humidity (%): 50-85 instead of 30 - 70 % recommended by the OECD guideline 406.
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hours daily,light-dark cycle


IN-LIFE DATES: From: 1986-01-13 To: 1986-03-29
Route:
epicutaneous, occlusive
Vehicle:
other: 96% ethanol was used instead of 80 % recommended by the OECD guideline 406
Concentration / amount:
Induction 15 %

One group of 20 test animals were treated with 0.3 ml of 15 % test substance in ethanol while a group of 10 control animals were treated with 0.3 ml of ethanol in Hill Top Chambers for a period of 6 hours weekly for 3 induction exposures.
Day(s)/duration:
6 hours, weekly, 3 induction exposures
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
Challenge 15 %
Rechallenge 15 % and 7.5 %
Day(s)/duration:
two weeks after the third induction exposure, 6 h exposure
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
other: acetone
Concentration / amount:
15 % and 7.5 %
Day(s)/duration:
rechallenge 18 days after challenge
No. of animals per dose:
20 animals in the test substance group and 10 animals in the vehicle control group
Details on study design:
RANGE FINDING TESTS:
INDUCTION: The entire back and both sides were clipped one day prior to application. Four animals were exposed for 6 hour period to various concentrations (0.3 ml of each/patch)of the test substance.
Concentrations -20 %, 10 %, 5 %, 2.5 % in ethanol 96 %
Grading: at 24hours and 48 hours
Challenge: a single dermal treatment was performed in 2 guinea pigs using 15% dilution of the test compound in acetone and responses were graded at 24 and 48 hours


MAIN STUDY
A. INDUCTION EXPOSURE
Prior to treatment the left shoulder of each animal was clipped with a small animal clipper. 0,3 ml of the freshly prepared test substance were applied to the Hill Top Chambers and placed on the clipped surface of each animal in the test group and secured with rubber dental dam. Animals were immobilized in metal restrainers for 6 hours. After that time patches were taken off and the test substance was removed with a gentle rinse of warm water before returning the animals to their cages. The procedure was repeated at the same site once a week for the next two weeks.
- No. of exposures: three
- Exposure period: once weekly for three weeks
- Test groups: 20 animals were exposed to 0.3 ml of 15 % in ethanol 96 %
- Control group: 10 animals, procedure not described
- Site: back and both sides of the animal
- Frequency of applications: once a week
- Duration: 6 hours
- Concentrations: 15 % test substance in ethanol 96 %


B. CHALLENGE EXPOSURE
The animals from the test group as well as from the control group were treated following the same patching procedure as described for induction.
- No. of exposures: one 6 hours exposure
- Day(s) of challenge: two weeks after the third induction exposure
- Exposure period: 6 hour under occlusion
- Test groups: 0.3 ml of 15% dilution in acetone
- Control group0.3 ml of 15% dilution in acetone
- Site: patches were applied to a naive skin site
- Concentrations: 15% test substance in acetone
- Evaluation (hr after challenge): 24 and 48 hours


OTHER:
RECHALLENGE:
It was done 18 days after challenge. Test animals and new untreated control animals were treated on naive skin analogously to induction and challenge and grading at 24, 44, 48 hours. Concentrations for rechallgenge 15 % and 7.5 % in acetone.

Grading of all animals was done by positioning them under a four tube fluorescent type light. The control animals were graded before the test animals according to the Scoring system below.
Scores:
No reaction 0
slight patchy erythema ± (0,5)
Slight, but confluent or moderate
Patchy erythema 1
Moderate erythema 2
Severe erythema with or without edema 3
Challenge controls:
Challenge controls was 15 % test substance in acetone. Rechallenge controls were 7.5 % and 15 % test substance in acetone
Positive control substance(s):
no
Positive control results:
None
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
15% in acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
1/20 animal (grade 1)
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 15% in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: 1/20 animal (grade 1).
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
15% in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive response 
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive response .
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
15% in acetone
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
1/20 animal (grade 1)
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 15% in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: 1/20 animal (grade 1).
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
15% in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive response 
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive response .
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
15% acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive response 
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 15% acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
7.5% in acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive response 
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 7.5% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
15% in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive response 
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive response .
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
7.5% in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 7.5% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
Reading:
rechallenge
Hours after challenge:
44
Group:
test chemical
Dose level:
15% in acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive response 
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 44.0. Group: test group. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
Reading:
rechallenge
Hours after challenge:
44
Group:
test chemical
Dose level:
7.5% in acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive response 
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 44.0. Group: test group. Dose level: 7.5% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
Reading:
rechallenge
Hours after challenge:
44
Group:
negative control
Dose level:
15% in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive response 
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 44.0. Group: negative control. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive response .
Reading:
rechallenge
Hours after challenge:
44
Group:
negative control
Dose level:
7.5% in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 44.0. Group: negative control. Dose level: 7.5% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
15% in acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive response 
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
15% in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive response 
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive response .
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
7.5% in acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive response 
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 7.5% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
7.5% in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 7.5% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
Group:
positive control
Remarks on result:
not measured/tested

No skin alterations were observed during the induction period with 15 % test substance in ethanol 96%. At challenge, slight erythema was observed in 1/20 test animals. No skin reactions were observed in the control animals. Both test and control animals were rechallenged with 15 % and 7.5% test substance in acetone. No skin responses were observed at rechallenge. Normal weight gains were observed during the study.

It was concluded that the test substance is not a sensitizer.

Interpretation of results:
GHS criteria not met
Conclusions:
MDEA-Esterquat C16-18 and C18 unsatd. did not induce sensitization in the guinea pig model.
Executive summary:

In a dermal sensitization study according to OECD guideline 406; 12 May, 1981 with MDEA-Esterquat C16-18 and C18 unsatd.   (80 % a.i) in IPA, Pirbright - Hartley guinea pig (10 male and 10 female) were tested using the method of Bühler

No skin alterations were observed during the induction period with 15 % test substance in ethanol 96%. At challenge, slight erythema was observed in 1/20 test animals. No skin reactions were observed in the control animals. Both test and control animals were rechallenged with 15 % and 7.5 % test substance in acetone. No skin responses were observed at rechallenge.

In this study, MDEA-Esterquat C16-18 and C18 unsatd.  is not a dermal sensitizer.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1986-07-03 to 1986-08-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Concentration of test substance used for induction was not the highest to cause mild irritation.
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A valid Buehler test conducted acording to guideline with acceptable restrictions is available, which is reliable with 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.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH & Co.
- Age at study initiation: Not available
- Weight at study initiation: 327 - 387 grams
- Housing: 5 aniamls in one cage, Macrolon Plastic cages IV
- Diet (e.g. ad libitum): ad libitum, Ssniff-G
- Water (e.g. ad libitum):ad libitum, aqua fontana
- Acclimation period: 4 days instead of 5 days recommended by the OECD guideline 406


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2
- Humidity (%): 50 - 85 % instead of 30 – 70 % recommended by the OECD guideline 406
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): Fluorescent light 120 lux.


IN-LIFE DATES: From: 1986-07-03 To: 1986-08-01
Route:
epicutaneous, occlusive
Vehicle:
other: Induction: ethanol 96 % was used instead of 80 % recommended by the OECD guideline 406
Concentration / amount:
Induction 15 % test substance in ethanol 96 %
One group of 20 test animals were treated with 0.3ml of 15% test substance in ethanol for a period of 6 hours weekly for 3 induction exposures.

Day(s)/duration:
weekly, 3 induction exposures, 6h exposure
Route:
epicutaneous, occlusive
Vehicle:
other: Acetone
Concentration / amount:
7.5 % test substance in acetone

Day(s)/duration:
two weeks after third induction, 6 h exposure
No. of animals per dose:
20 animals in the test substance group and 10 animals in the vehicle control group
Details on study design:
RANGE FINDING TESTS:
The entire back and both sides were clipped one day prior to application.
Four animals were exposed to various concentrations of the test substance
Concentration: 15% and 7.5% test substance in acetone
Grading: at 24 hours and 48 hours



MAIN STUDY
A. INDUCTION EXPOSURE
Prior to treatment the left shoulder of each animal was clipped with a small animal clipper. 0,3 ml of the freshly prepared test substance were applied to the Hill Top Chambers and placed on the clipped surface of each animal in the test group and secured with rubber dental dam. Animals were immobilized in metal restrainers for 6 hours. After that time patches were taken off and the test substance was removed with a gentle rinse of warm water before returning the animals to their cages. The procedure was repeated at the same site once a week for the next two weeks.
- No. of exposures: 3 induction exposures
- Exposure period: 6 hours
- Test groups: 20 animals were exposed to 0.3 ml of 15 % test substance in ethanol 96 %
- Control group: 10 animals, procedure not described
- Site: upper left quadrant of the back of the test animal
- Frequency of applications: once a week for 3 weeks.
- Duration: 6 hours under occlusion
- Concentrations: 15 % test substance in ethanol 96 %



B. CHALLENGE EXPOSURE
The animals from the test group as well as from the control group were treated following the same patching procedure as described for induction.
- No. of exposures: one 6 hour exposure
- Day(s) of challenge: two weeks after third induction
- Exposure period: 6 hours under occlusion
- Test groups: 0.3 ml of 7.5 % test substance in acetone
- Control group: 0.3 ml of 7.5 % test substance in acetone
- Site: Patches were applied to a naive skin site
- Concentrations: 7.5 % test substance in acetone
- Evaluation (hr after challenge): 24 and 48 hours after challenge exposure.


OTHER:
Grading of all animals was done by positioning them under a four tube fluorescent type light. The control animals were graded before the test animals according to the Scoring system below.

Scores:
No reaction 0
slight patchy erythema ± (0,5)
Slight, but confluent or moderate
Patchy erythema 1
Moderate erythema 2
Severe erythema with or without edema 3
Challenge controls:
10 control animals were challenged with 7.5 % test substance in acetone
Positive control substance(s):
no
Positive control results:
None
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
7.5 % in acetone
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 7.5 % in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive responses.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
7.5 % in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 7.5 % in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
7.5 % in acetone
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
slight patchy erythema, socre 0.5 was observed in 3 animals
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 7.5 % in acetone. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: slight patchy erythema, socre 0.5 was observed in 3 animals.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
7.5 % in acetone
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no animals with positive responses
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 7.5 % in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
Group:
positive control
Remarks on result:
not measured/tested

No skin alterations were observed during the induction period with 15 % test substance in ethanol 96 %. After challenge with 7,5 % test article, partly slight, patchy erythema (score 0,5) was observed in the test group in 3/20 animals at the 48 hour reading. The control group showed no skin reactions. Normal weight gains were obseved during the study.

Interpretation of results:
GHS criteria not met
Conclusions:
MDEA-esterquat C16-18 and C18 unsatd. did not induce sensitization in the guinea pig model.
Executive summary:

In a dermal sensitization study according to OECD guideline 406, 12 May, 1981 with MDEA-Esterquat C16-18 and C18 unsatd.  (80 % a.i) in IPA, Pirbright-Hartley guinea pig (10 male and 10 female) were tested using the method of Bühler.

 

No skin alterations were observed during the induction period with 15 % test substance in ethanol 96%. After challenge with 7.5 % test article no skin reaction was observed in the test group at the 24 hour reading, partly slight, patchy erythema (score 0.5) was observed in 3/20 animals at the 48 hour reading. No skin reactions were observed in the control animals. There was a very slight intergroup difference in skin alteration between test- and control group.

 

In this study, MDEA-Esterquat C16-18 and C18 unsatd.  is not a dermal sensitizer.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Human data

Ethical considerations

“The material under registration is for use in the manufacture of commercial fabric softener products that are used by millions of consumers on a daily basis. Because of this, and after having established the material’s lack of contact sensitization potential in the Guinea Pig, it was thought prudent to conduct confirmatory studies in a limited number of volunteers. The objective was to confirm that, as expected, no unforeseen reactions would occur when the material is in contact with people’s skin under consumer relevant conditions. To that end, three separate standard Human Result Insult Patch Tests (HRIPT) were conducted as described below”.

Data are generated in accordance with ethical considerations outlined in the Procter & Gamble policy “company policy for research involving human subjects”. This policy includes the principles of the ICH-GCP Regulation and the Declaration of Helsinki.

Human Repeat Insult Patch Tests

Data from three Human Repeat Insult Patch Test (HRIPT) studies are available. Dermal sensitisation studies were conducted according to the publications of Griffith, J.F., (1969), Predictive and Diagnostic Testing for Contact Sensitisation, Toxicol. Appl. Pharmacol., Suppl.3:90 and Stotts, J., (1980), Planning, Conduct and Interpretation Human Predictive Sensitisation Patch Test, Current Concepts in Cutaneous Toxicity, pp 41-53. During a three week period, volunteers were exposed under occlusive dressing in 9 successive occasions to induction patches containing 0.5 mL w/v aqueous solution of test substance. In each of the 9 occasions, the test substance was removed 24 hours after application of the patch. 14 days after exposure to the final induction patch, volunteers were challenged using the same concentration and the same procedure adopted for induction. The concentration for induction was chosen to cause mild to moderate irritation. Results were graded using a scoring system from 1 - 6 for erythema and edema, at 48 and 96 hours after challenge.

In the first study MDEA-Esterquat C16-18 and C18 unsatd. was tested as 1.5 % aqueous dilution. 90 volunteers took part in this study, six dropped out due to personal reason and a total of 84 volunteers were challenged. Acceptable irritation with mild (score 1) to particular moderate (score 2) erythema was observed throughout the study. No edema, which would be indicative for sensitisation was observed neither during induction nor during elicitation.

In two additional studies with MDEA-Esterquat C16-18 and C18 unsatd., a total of 210 volunteers were exposed to a 2.0 % aqueous dilution of test substance. 11 volunteers dropped out due to personal reason. Therefore a total of 199 study participants were challenged, using the same concentration of 2.0 % substance in aqueous dilution as for induction. A steady, acceptable irritation with mild (score 1) to particular moderate (score 2) erythema was observed throughout the study. As in the first study, no edema, which would be indicative for sensitisation was observed during induction or challenge.

Animal data

Data from two Bühler studies and three Human Repeat Insult Patch Test studies are available.

In two dermal sensitisation studies according to OECD Guideline 406 (12 May 1981) with MDEA-Esterquat C16-18 and C18 unsatd.  (80 % a.i.) in isopropanol, Pirbright-Hartley guinea pigs (10 male and 10 female in each study) were tested using the method of Bühler.

In the first study no skin alterations were observed during the induction period with 15 % test substance in 96 % ethanol. At challenge with 15 % test substance in acetone, slight erythema was observed in 1/20 test animals. No skin reactions were observed in the control animals. Both test and control animals were re-challenged with 15 % and 7.5 % MDEA-Esterquat C16-18 and C18 unsatd.  in acetone. No skin responses were observed upon re-challenge.

In the second study no skin alterations were observed during the induction period with 15 % test substance in 96 % ethanol. 48 hours after challenge with 7.5 % test article, partly slight, patchy erythema (score 0.5) was observed in the test group in 3/20 animals. No skin reactions were observed in the control animals. There was a very slight intergroup difference in the skin alterations between test- and control group.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In conclusion, results of Human Repeat Insult Patch Tests and supporting data from two Bühler studies with guinea pigs indicate that MDEA-Esterquat C16-18 and C18 unsatd. does not induce skin sensitisation in humans.  According to GHS Regulation EC No 1272/2008 MDEA-Esterquat C16-18 and C18 unsatd.  is not classified as “sensitising” and labelling is not required.