Long-chain alkenyl amide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 13, 2016 to October 14, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

A OECD, GLP compliant Buehler study on the test article was commissioned for R&D purposes. Therefore, in the interest of animal welfare it was considered scientifically unjustified to re-run the same study according to the LLNA method.

Test material

Test material information

1

Reference substance name:

Reaction products of fatty acids, C16-18, C18 unsatd. with Amines, polyethylenepoly-, triethylenetetramine fraction and 3-(C9–C15, C12 rich, alk-1-enyl)dihydro-2,5-furandione

EC Number:

947-263-6

Cas Number:

68478-81-9

Molecular formula:

C36H68N4 - C76H136N4O6

IUPAC Name:

Reaction products of fatty acids, C16-18, C18 unsatd. with Amines, polyethylenepoly-, triethylenetetramine fraction and 3-(C9–C15, C12 rich, alk-1-enyl)dihydro-2,5-furandione

Test material form:

liquid: viscous

Details on test material:

- Appearance: Dark red-brown, thick vuscous liquid
- Storage: Ambient room temperature, in a closed container

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

Prior to use, all animals were acclimated for at least five days. Animals were individually housed in wire mesh suspension cages. The animals were maintained according to the recommendations contained in teh National Academy Press 2011: ' Guide for the Care and Use of Laboratory Animals' The animals were supplied Purina Guinea Pig Chow and tap water ad libitum during both acclimation and test periods.

ENVIRONMENTAL CONDITIONS:
Light/Dark Cycle : 12 hours light, 12 hour dark cycle
Temperature: 64 - 79 F
Relative Humidity: 30-70%

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

100%

Day(s)/duration:

Weekly intervals for 3 weeks

Adequacy of induction:

other: The highest non-Irritating concentration

Challenge

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

100%

Day(s)/duration:

Once

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

20

Details on study design:

the test substance was evaluated for sensitization potential by applying 0.4 mL at a 100% concentration directly inyo Hilltop Chambers and applying them to the clipped left shoulder of twentu albino guinea pigs in the follwing manner: the animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximately 6 hours later, the tape and chambers were removed. Two additional induction doses were conducted follwoing the same procedure, at weekly intervals.

Two weeks after the final application the animals received a topical primary challenge ( 6 hurs contact) of the test substance at 100% concentration, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application

Challenge controls:

Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challemge dose, at a 100% concentration. The four remaining guinea pigs were designated for a re-challenge, if necessary

Positive control substance(s):

yes

Remarks:

1-Chloro-2,4-Dinitrobenzene

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100%

No. with + reactions:

2

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

100%

No. with + reactions:

1

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 3

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

100%

No. with + reactions:

1

Total no. in group:

6

Remarks on result:

no indication of skin sensitisation

Results 4

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

100%

No. with + reactions:

0

Total no. in group:

6

Remarks on result:

no indication of skin sensitisation

Results 5

Group:

positive control

Remarks on result:

not measured/tested

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is not considered to be a skin sensitizer based on the results of this study.

Executive summary:

The test substance was evaluated for sensitization potential by applying 0.4 mL at a 100% concentration directly into Hilltop Chambers and applying them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximatley six hours later, the tape and chambers were removed. Two additional induction doses were conducted following the same procedure, at weekly intervals.

Two weeks after the final applicaton the animals received a topical primary challenge dose ( 6 hours contact) of the test substance at 100% concentration, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application.

Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challenge dose, at a 100% concentration. The four remaining guinea pigs were designated for a re-challenge, if necessary.

Following primary challenge of the test substance, the incidence of grade 1 response or greater in the test group (2 of 20) was compared to that of the naive control group (1 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.