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Description of key information

In a Klimisch 1 GLP read across study from Leuschner (2013) the potential of the test item to produce skin sensitisation reactions in guinea pigs in a test model according to the Magnusson and Kligman method was investigated. Under the present test conditions, the test item revealed no sensitising properties in guinea pigs. The test item was considered to be non-sensitising to the skin.


It is considered likely, that the source substance Amidoamine 2 (UVCB) based on hydrogenated tallow will show comparable effects in a Guinea Pig Maximisation Test (GPMT) of Magnusson and Kligman as the target Amidoamine 2 (UVCB, low nitrogen) based on hydrogenated palm oil due to the similar chemical composition and (bio)transformation products.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

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
Justification for type of information:
For further information on the read-across approach please have a look at the attached supporting information.
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 August 2013 - 23 October 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
An OECD 406 GLP study for a similar substance is available and is used within a read-across approach. The composition of source and target substance is described and discussed in detail in the attached supporting information as well as the read-across justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Presented OECD 406 GPMT study was initially conducted for non-REACH related use for a structural analogue of the registered substance.
In order to avoid further vertebrate animal testing (i.e. conduct an OECD 429 LLNA) this OECD 406 study is presented within a read across approach (structural analogue; one-to-one read-across).



Specific details on test material used for the study:
Test item without emulsifier was investigated.

Source substance:

Amidoamine 2 (UVCB, low nitrogen) based on hydrogenated tallow instead of hydrogenated palm oil):
Former chemical name: Amides, from diethylenetriamine and hydrogenated tallow
CAS No.: 68920-82-1
Name of test material (as cited in study report): FCM (DETA)M C16-18 TLW hydrogenated (Amidoamine 2 (UVCB) based on hydrogenated tallow instead of hydrogenated palm oil)
New chemical name: Glycerides, C16-18 (even numbered) and their amidation products with diethylenetriamine
Physical state: pale yellowish solid at 20 °C
Batch No.: PU22340011
Expiry date of batch: 21 August 2014
Purity: 100 % (UVCB)
Storage condition of test material: Room temperature, protected from light
Stability: stable under test conditions

Target substance:

Amidoamine 2 (UVCB, low nitrogen):
Former chemical name: Amides, from diethylenetriamine and hydrogenated palm oil
CAS No.: 1618093-67-6
New chemical name: Glycerides, C16-18 (even numbered) and their amidation products with diethylenetriamine
Physical state: pale yellowish solid at 20 °C
Batch No.: PU50070067
Purity: 100 % (UVCB)
Storage condition of test material: Room temperature, protected from light
Stability: stable under test conditions
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
The animals were kept in pairs in MAKROLON cages at a room temperature of 20°C ± 3°C (maximum range) and a relative humidity of 55% ± 15% (maximum range). Rooms were lit (about 150 lux at approx. 1.50 m room height) on a 12-hour light/12-hour dark cycle. Tap water (in drinking bottles) was offered ad libitum. Drinking water is examined according to the 'Deutsche Trinkwasserverordnung, 2001'.
Commercial diet, ssniff® Ms-H V2233 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) served as food. This food was offered ad libitum.

Number of animals: 15
Sex: Male
Age (at start of administration): Approx. 29 days
Body weight (at start of administration): 294 - 337 g
Positive control group: 313 – 371 g
Identification of animals: By cage label and coloured marks
Adaptation period: At least 5 days

Mortality: daily during the observation period
Clinical signs: daily during the observation period
Body weight: at start of study and at study termination
Route:
intradermal
Vehicle:
other: sesame oil
Concentration / amount:
Three pairs of intradermal injections of 0.1 mL were given in the shoulder region which was cleared of hair so that one of each pair lay on each side of midline.

(1) Freund's complete adjuvant (FCA) (diluted 1 : 1 with 0.9% NaCl
(2) the test item (10% in sesame oil)
(3) the test item in a 1+1 mixture (v/v) FCA/physiological saline
Day(s)/duration:
day 0
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, open
Vehicle:
other: vaseline
Concentration / amount:
0.5 mL sodium laurylsulfate 10% in vaseline
Day(s)/duration:
day 6
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
75% suspension of test item in sesame oil
Day(s)/duration:
day 7 / exposure time: 48 hours
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
75% suspension of test item in sesame oil
Day(s)/duration:
day 21 / exposure time: 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 test and 5 control animals were used as a common procedure for animal welfare reason.
Positive control group was carried out non-concurrently with this study during May/June 2013. with 20 animals,
Details on study design:
Induction
The skin reaction results of the first induction exposure were evaluated at 24 and 48 hours, of the second induction at 48 and 72 hours after start of exposure.

Challenge
Days 23 and 24
- 21 hours after removing the filter paper the challenge area was cleaned and cleared of hair if necessary
- three hours later (at 48 hours from the start of challenge application) the skin reaction was observed and recorded
- 24 hours after this observation a second observation (72 hours) was made and recorded.
Positive control substance(s):
yes
Remarks:
α-hexyl cinnamic aldehyde
Positive control results:
The animals of the positive control group (same origin (strain) as those used in the study) were treated with a 10% (v/v) α-hexyl cinnamic aldehyde solution
intracutaneously in stage 1, undiluted α-hexyl cinnamic aldehyde topically in stage 2 and a 0.01% α-hexyl cinnamic aldehyde solution in stage 3.
In the case of the adjuvant type test method for skin sensitisation detailed OECD 406 guideline or in the case of other adjuvant-type test methods, a response of at least 30% of the animals is considered positive. For the positive control a clear positive reactions 48 and 72 h after challenge were observed (48 h: 100% , 72 h: 65 %). The positive control acceptance criteria were therefore satisfied.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2 g of a 75% suspension of the test item in sesame oil/animal
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible change (treated skin area)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
2g sesame oil/animal
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no visible change (treated skin area)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.01% α-hexyl cinnamic aldehyde solution in sesame oil/animal
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
discrete/patchy erythema or moderate and confluent erythema observed in treated skin area of all animals
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
2 g of a 75% suspension of the test item in sesame oil/animal
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible change (treated skin area)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
2g sesame oil/animal
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no visible change (treated skin area)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
0.01% α-hexyl cinnamic aldehyde solution in sesame oil/animal
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
discrete or patchy erythema observed in treated skin area of 13 animals
Remarks on result:
positive indication of skin sensitisation

Preliminary studies



Six concentrations of the test item were tested by intracutaneous injection employing a 72-hour observation period: 0.01, 0.1, 0.5, 1, 5 or 10% suspensions in sesame oil. A suspension of 10% was the maximum feasible applicable concentration. A concentration of 0.01% did not reveal any changes. Concentrations of 0.1%, 0.5% or 1% revealed a discrete or patchy erythema 24, 48 and 72 hours after administration. Concentration of 5% or 10% revealed a moderate and confluent erythema 24 hours and a discrete or patchy erythema 48 and 72 hours after administration. Six concentrations of test item were tested by topical application: 1, 5, 10, 25, 50 and 75% suspensions in sesame oil. A 75% concentration of the test item in sesame oil was the maximum concentration that could be prepared in order to produce a homogeneous test item-vehicle suspension. No higher concentrated suitable suspensions could be prepared. Non-depilated skin (48-hour) or depilated skin (24-hour exposure). No skin reactions were observed at any concentration. Hence, it was decided to use a 10% suspension for the 1st (intracutaneous) induction stage, 75% suspensions for the 2nd (topical) induction stage and for the challenge in the main study.


Main study


A 10% suspension of the test item in sesame oil chosen for the 1st (intracutaneous) induction stage revealed a discrete or patchy erythema in all 10 animals 24 and 48 hours after administration. 2 g of a 75% suspension test item/animal chosen for the 2nd (topical) induction stage were not irritating to the shaved skin in the preliminary
experiment. Hence, in the main study the skin was coated with sodium laurylsulfate on the day before stage 2 induction in order to induce a local irritation. This treatment
resulted in a discrete or patchy erythema in all animals 48 and 72 hours after start of exposure. The challenge with 2 g of a 75% suspension of test item in sesame oil/animal revealed no skin irritation in any animal and, thus, the test item had no sensitising properties. The vehicle control revealed no skin reactions. Animals of the same strain treated with α-hexyl cinnamic aldehyde in sesame oil exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema (grade 2) or a discrete or patchy erythema (grade 1). The body weight gain of the animals treated with test item was within the range of the vehicle control during the experiment.
Behaviour remained unchanged during the course of the study. Given the negative response in all treated animals further testing was not considered necessary in order to reduce animal experiments for animal welfare reasons.


Under the present test conditions, the test item revealed no sensitising properties in guinea pigs in a test model according to MAGNUSSON and KLIGMAN.


Table 1: Skin reactions























































































































































































































































































































































































































































Animal
No.
1st stage 2nd stage 3rd stage   
Hours after start of treatment
 ShoulderShoulderFlank
 244824484872
     leftrightleftright
Group 1: Vehicle control
100110000
200110000
300110000
400110000
500110000
Group 2: Test item
611110000
711110000
811110000
911110000
1011110000
1111110000
1211110000
1311110000
1411110000
1511110000
Group 3: Positive Control (alpha-hexyl cinnamic aldehyde)
P1112120 0
P2112120 0
P3112120 0
P4112120 0
P5112120 0
P6112110 0
P7112110 0
P8112120 0
P9112120 0
P10112110 0
P11112120 0
P12112120 0
P13112120 0
P14112110 0
P15112110 0
P16112110 0
P17112120 0
P18112120 0
P19112120 0
P20112110 0

0 no visible change 
1 discrete or patchy erythema
2 moderate and confluent erythema
3 intense erythema and swelling


Table 2: Body weight










































































































































































































































Animal No.at start of studystudy termination
Group 1: Vehicle control
1337540
2318469
3294404
4306467
5301436
Mean311.2463.2
SD16.950.5
t--
Group 2: Test item
6302451
7294454
8326505
9329468
10328461
11322468
12307454
13317532
14333490
15307452
Mean316.5437.5
SD 27.1
t0.6690.523
Group 3: Positive control (α-hexyl cinnamic aldehyde)
P1358474
P2347507
P3348516
P4341514
P5366516
P6342482
P7371551
P8346510
P9349532
P10333455
P11351510
P12366504
P13343474
P14331469
P15325436
P16368548
P17342497
P18313457
P19349489
P20351473
Mean347.0495.7
SD14.730.8

SD = standard deviation
t = t-value (Student's t-test)
** = significantly different from control (p ≤ 0.01)
body weight in g

Interpretation of results:
GHS criteria not met
Conclusions:
Under the present test conditions, the test item revealed no sensitising properties in guinea pigs in a test model according to MAGNUSSON and KLIGMAN.
Executive summary:

In a Klimisch 1 GLP study from Leuschner (2013) the potential of the test item to produce skin sensitisation reactions in guinea pigs in a test model according to the Magnusson and Kligman method was

investigated. Under the present test conditions, the test item revealed no sensitising properties in guinea pigs.

The test item was considered to be non-sensitising to the skin.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
15 August 2013 - 23 October 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
An OECD 406 GLP study for a similar substance is available and is used within a read-across approach. The composition of source and target substance is described and discussed in detail in the attached supporting information as well as the read-across justification.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Presented OECD 406 GPMT study was initially conducted for non-REACH related use for a structural analogue of the registered substance.
In order to avoid further vertebrate animal testing (i.e. conduct an OECD 429 LLNA) this OECD 406 study is presented within a read across approach (structural analogue; one-to-one read-across).



Specific details on test material used for the study:
Target substance:

Amidoamine 2 (UVCB, low nitrogen):
Former chemical name: Amides, from diethylenetriamine and hydrogenated palm oil
CAS No.: 1618093-67-6
New chemical name: Glycerides, C16-18 (even numbered) and their amidation products with diethylenetriamine
Physical state: pale yellowish solid at 20 °C
Batch No.: PU50070067
Purity: 100 % (UVCB)
Storage condition of test material: Room temperature, protected from light
Stability: stable under test conditions
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
The animals were kept in pairs in MAKROLON cages at a room temperature of 20°C ± 3°C (maximum range) and a relative humidity of 55% ± 15% (maximum range). Rooms were lit (about 150 lux at approx. 1.50 m room height) on a 12-hour light/12-hour dark cycle. Tap water (in drinking bottles) was offered ad libitum. Drinking water is examined according to the 'Deutsche Trinkwasserverordnung, 2001'.
Commercial diet, ssniff® Ms-H V2233 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) served as food. This food was offered ad libitum.

Number of animals: 15
Sex: Male
Age (at start of administration): Approx. 29 days
Body weight (at start of administration): 294 - 337 g
Positive control group: 313 – 371 g
Identification of animals: By cage label and coloured marks
Adaptation period: At least 5 days

Mortality: daily during the observation period
Clinical signs: daily during the observation period
Body weight: at start of study and at study termination
Route:
intradermal
Vehicle:
other: sesame oil
Concentration / amount:
Three pairs of intradermal injections of 0.1 mL were given in the shoulder region which was cleared of hair so that one of each pair lay on each side of midline.

(1) Freund's complete adjuvant (FCA) (diluted 1 : 1 with 0.9% NaCl
(2) the test item (10% in sesame oil)
(3) the test item in a 1+1 mixture (v/v) FCA/physiological saline
Day(s)/duration:
day 0
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, open
Vehicle:
other: vaseline
Concentration / amount:
0.5 mL sodium laurylsulfate 10% in vaseline
Day(s)/duration:
day 6
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
75% suspension of test item in sesame oil
Day(s)/duration:
day 7 / exposure time: 48 hours
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: sesame oil
Concentration / amount:
75% suspension of test item in sesame oil
Day(s)/duration:
day 21 / exposure time: 24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 test and 5 control animals were used as a common procedure for animal welfare reason.
Positive control group was carried out non-concurrently with this study during May/June 2013. with 20 animals,
Details on study design:
Induction
The skin reaction results of the first induction exposure were evaluated at 24 and 48 hours, of the second induction at 48 and 72 hours after start of exposure.

Challenge
Days 23 and 24
- 21 hours after removing the filter paper the challenge area was cleaned and cleared of hair if necessary
- three hours later (at 48 hours from the start of challenge application) the skin reaction was observed and recorded
- 24 hours after this observation a second observation (72 hours) was made and recorded.
Positive control substance(s):
yes
Remarks:
α-hexyl cinnamic aldehyde
Positive control results:
The animals of the positive control group (same origin (strain) as those used in the study) were treated with a 10% (v/v) α-hexyl cinnamic aldehyde solution
intracutaneously in stage 1, undiluted α-hexyl cinnamic aldehyde topically in stage 2 and a 0.01% α-hexyl cinnamic aldehyde solution in stage 3.
In the case of the adjuvant type test method for skin sensitisation detailed OECD 406 guideline or in the case of other adjuvant-type test methods, a response of at least 30% of the animals is considered positive. For the positive control a clear positive reactions 48 and 72 h after challenge were observed (48 h: 100% , 72 h: 65 %). The positive control acceptance criteria were therefore satisfied.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2 g of a 75% suspension of the test item in sesame oil/animal
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible change (treated skin area)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
2g sesame oil/animal
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no visible change (treated skin area)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.01% α-hexyl cinnamic aldehyde solution in sesame oil/animal
No. with + reactions:
20
Total no. in group:
20
Clinical observations:
discrete/patchy erythema or moderate and confluent erythema observed in treated skin area of all animals
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
2 g of a 75% suspension of the test item in sesame oil/animal
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible change (treated skin area)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
2g sesame oil/animal
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no visible change (treated skin area)
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
positive control
Dose level:
0.01% α-hexyl cinnamic aldehyde solution in sesame oil/animal
No. with + reactions:
13
Total no. in group:
20
Clinical observations:
discrete or patchy erythema observed in treated skin area of 13 animals
Remarks on result:
positive indication of skin sensitisation

Preliminary studies



Six concentrations of the test item were tested by intracutaneous injection employing a 72-hour observation period: 0.01, 0.1, 0.5, 1, 5 or 10% suspensions in sesame oil. A suspension of 10% was the maximum feasible applicable concentration. A concentration of 0.01% did not reveal any changes. Concentrations of 0.1%, 0.5% or 1% revealed a discrete or patchy erythema 24, 48 and 72 hours after administration. Concentration of 5% or 10% revealed a moderate and confluent erythema 24 hours and a discrete or patchy erythema 48 and 72 hours after administration. Six concentrations of test item were tested by topical application: 1, 5, 10, 25, 50 and 75% suspensions in sesame oil. A 75% concentration of the test item in sesame oil was the maximum concentration that could be prepared in order to produce a homogeneous test item-vehicle suspension. No higher concentrated suitable suspensions could be prepared. Non-depilated skin (48-hour) or depilated skin (24-hour exposure). No skin reactions were observed at any concentration. Hence, it was decided to use a 10% suspension for the 1st (intracutaneous) induction stage, 75% suspensions for the 2nd (topical) induction stage and for the challenge in the main study.


Main study


A 10% suspension of the test item in sesame oil chosen for the 1st (intracutaneous) induction stage revealed a discrete or patchy erythema in all 10 animals 24 and 48 hours after administration. 2 g of a 75% suspension test item/animal chosen for the 2nd (topical) induction stage were not irritating to the shaved skin in the preliminary
experiment. Hence, in the main study the skin was coated with sodium laurylsulfate on the day before stage 2 induction in order to induce a local irritation. This treatment
resulted in a discrete or patchy erythema in all animals 48 and 72 hours after start of exposure. The challenge with 2 g of a 75% suspension of test item in sesame oil/animal revealed no skin irritation in any animal and, thus, the test item had no sensitising properties. The vehicle control revealed no skin reactions. Animals of the same strain treated with α-hexyl cinnamic aldehyde in sesame oil exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema (grade 2) or a discrete or patchy erythema (grade 1). The body weight gain of the animals treated with test item was within the range of the vehicle control during the experiment.
Behaviour remained unchanged during the course of the study. Given the negative response in all treated animals further testing was not considered necessary in order to reduce animal experiments for animal welfare reasons.


Under the present test conditions, the test item revealed no sensitising properties in guinea pigs in a test model according to MAGNUSSON and KLIGMAN.


Table 1: Skin reactions























































































































































































































































































































































































































































Animal
No.
1st stage 2nd stage 3rd stage   
Hours after start of treatment
 ShoulderShoulderFlank
 244824484872
     leftrightleftright
Group 1: Vehicle control
100110000
200110000
300110000
400110000
500110000
Group 2: Test item
611110000
711110000
811110000
911110000
1011110000
1111110000
1211110000
1311110000
1411110000
1511110000
Group 3: Positive Control (alpha-hexyl cinnamic aldehyde)
P1112120 0
P2112120 0
P3112120 0
P4112120 0
P5112120 0
P6112110 0
P7112110 0
P8112120 0
P9112120 0
P10112110 0
P11112120 0
P12112120 0
P13112120 0
P14112110 0
P15112110 0
P16112110 0
P17112120 0
P18112120 0
P19112120 0
P20112110 0

0 no visible change 
1 discrete or patchy erythema
2 moderate and confluent erythema
3 intense erythema and swelling


 


Table 2: Body weight










































































































































































































































Animal No.at start of studystudy termination
Group 1: Vehicle control
1337540
2318469
3294404
4306467
5301436
Mean311.2463.2
SD16.950.5
t--
Group 2: Test item
6302451
7294454
8326505
9329468
10328461
11322468
12307454
13317532
14333490
15307452
Mean316.5437.5
SD 27.1
t0.6690.523
Group 3: Positive control (α-hexyl cinnamic aldehyde)
P1358474
P2347507
P3348516
P4341514
P5366516
P6342482
P7371551
P8346510
P9349532
P10333455
P11351510
P12366504
P13343474
P14331469
P15325436
P16368548
P17342497
P18313457
P19349489
P20351473
Mean347.0495.7
SD14.730.8

SD = standard deviation
t = t-value (Student's t-test)
** = significantly different from control (p ≤ 0.01)
body weight in g

Interpretation of results:
GHS criteria not met
Conclusions:
Under the present test conditions, the test item revealed no sensitising properties in guinea pigs in a test model according to MAGNUSSON and KLIGMAN.
It is considered likely, that the source substance Amidoamine 2 (UVCB) based on hydrogenated tallow will show comparable effects in a Guinea Pig Maximisation Test (GPMT) of Magnusson and Kligman as the target Amidoamine 2 (UVCB, low nitrogen) based on hydrogenated palm oil due to the similar chemical composition and (bio)transformation products.
Executive summary:

In a Klimisch 1 GLP study from Leuschner (2013) the potential of the test item to produce skin sensitisation reactions in guinea pigs in a test model according to the Magnusson and Kligman method was investigated. Under the present test conditions, the test item revealed no sensitising properties in guinea pigs.The test item was considered to be non-sensitising to the skin.


It is considered likely, that the source substance Amidoamine 2 (UVCB) based on hydrogenated tallow will show comparable effects in a Guinea Pig Maximisation Test (GPMT) of Magnusson and Kligman as the target Amidoamine 2 (UVCB, low nitrogen) based on hydrogenated palm oil due to the similar chemical composition and (bio)transformation products.

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