Glycerides, C16-18 (even numbered) and their amidation products with diethylenetriamine

Endpoint summary

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

Reference

Reference 1

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.

Reference 2

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
	Shoulder		Shoulder		Flank
	24	48	24	48	48		72
					left	right	left	right
Group 1: Vehicle control
1	0	0	1	1	0	0	0	0
2	0	0	1	1	0	0	0	0
3	0	0	1	1	0	0	0	0
4	0	0	1	1	0	0	0	0
5	0	0	1	1	0	0	0	0
Group 2: Test item
6	1	1	1	1	0	0	0	0
7	1	1	1	1	0	0	0	0
8	1	1	1	1	0	0	0	0
9	1	1	1	1	0	0	0	0
10	1	1	1	1	0	0	0	0
11	1	1	1	1	0	0	0	0
12	1	1	1	1	0	0	0	0
13	1	1	1	1	0	0	0	0
14	1	1	1	1	0	0	0	0
15	1	1	1	1	0	0	0	0
Group 3: Positive Control (alpha-hexyl cinnamic aldehyde)
P1	1	1	2	1	2	0		0
P2	1	1	2	1	2	0		0
P3	1	1	2	1	2	0		0
P4	1	1	2	1	2	0		0
P5	1	1	2	1	2	0		0
P6	1	1	2	1	1	0		0
P7	1	1	2	1	1	0		0
P8	1	1	2	1	2	0		0
P9	1	1	2	1	2	0		0
P10	1	1	2	1	1	0		0
P11	1	1	2	1	2	0		0
P12	1	1	2	1	2	0		0
P13	1	1	2	1	2	0		0
P14	1	1	2	1	1	0		0
P15	1	1	2	1	1	0		0
P16	1	1	2	1	1	0		0
P17	1	1	2	1	2	0		0
P18	1	1	2	1	2	0		0
P19	1	1	2	1	2	0		0
P20	1	1	2	1	1	0		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 study	study termination
Group 1: Vehicle control
1	337	540
2	318	469
3	294	404
4	306	467
5	301	436
Mean	311.2	463.2
SD	16.9	50.5
t	-	-
Group 2: Test item
6	302	451
7	294	454
8	326	505
9	329	468
10	328	461
11	322	468
12	307	454
13	317	532
14	333	490
15	307	452
Mean	316.5	437.5
SD		27.1
t	0.669	0.523
Group 3: Positive control (α-hexyl cinnamic aldehyde)
P1	358	474
P2	347	507
P3	348	516
P4	341	514
P5	366	516
P6	342	482
P7	371	551
P8	346	510
P9	349	532
P10	333	455
P11	351	510
P12	366	504
P13	343	474
P14	331	469
P15	325	436
P16	368	548
P17	342	497
P18	313	457
P19	349	489
P20	351	473
Mean	347.0	495.7
SD	14.7	30.8

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.

Reference 3

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
	Shoulder		Shoulder		Flank
	24	48	24	48	48		72
					left	right	left	right
Group 1: Vehicle control
1	0	0	1	1	0	0	0	0
2	0	0	1	1	0	0	0	0
3	0	0	1	1	0	0	0	0
4	0	0	1	1	0	0	0	0
5	0	0	1	1	0	0	0	0
Group 2: Test item
6	1	1	1	1	0	0	0	0
7	1	1	1	1	0	0	0	0
8	1	1	1	1	0	0	0	0
9	1	1	1	1	0	0	0	0
10	1	1	1	1	0	0	0	0
11	1	1	1	1	0	0	0	0
12	1	1	1	1	0	0	0	0
13	1	1	1	1	0	0	0	0
14	1	1	1	1	0	0	0	0
15	1	1	1	1	0	0	0	0
Group 3: Positive Control (alpha-hexyl cinnamic aldehyde)
P1	1	1	2	1	2	0		0
P2	1	1	2	1	2	0		0
P3	1	1	2	1	2	0		0
P4	1	1	2	1	2	0		0
P5	1	1	2	1	2	0		0
P6	1	1	2	1	1	0		0
P7	1	1	2	1	1	0		0
P8	1	1	2	1	2	0		0
P9	1	1	2	1	2	0		0
P10	1	1	2	1	1	0		0
P11	1	1	2	1	2	0		0
P12	1	1	2	1	2	0		0
P13	1	1	2	1	2	0		0
P14	1	1	2	1	1	0		0
P15	1	1	2	1	1	0		0
P16	1	1	2	1	1	0		0
P17	1	1	2	1	2	0		0
P18	1	1	2	1	2	0		0
P19	1	1	2	1	2	0		0
P20	1	1	2	1	1	0		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 study	study termination
Group 1: Vehicle control
1	337	540
2	318	469
3	294	404
4	306	467
5	301	436
Mean	311.2	463.2
SD	16.9	50.5
t	-	-
Group 2: Test item
6	302	451
7	294	454
8	326	505
9	329	468
10	328	461
11	322	468
12	307	454
13	317	532
14	333	490
15	307	452
Mean	316.5	437.5
SD		27.1
t	0.669	0.523
Group 3: Positive control (α-hexyl cinnamic aldehyde)
P1	358	474
P2	347	507
P3	348	516
P4	341	514
P5	366	516
P6	342	482
P7	371	551
P8	346	510
P9	349	532
P10	333	455
P11	351	510
P12	366	504
P13	343	474
P14	331	469
P15	325	436
P16	368	548
P17	342	497
P18	313	457
P19	349	489
P20	351	473
Mean	347.0	495.7
SD	14.7	30.8

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