Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

15 Nov – 15 Dec 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No periodically reliability checks were performed

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

adopted in 1992

Deviations:

yes

Remarks:

The initial concentration of the 1st induction was reduced for the 2nd and 3rd induction. The reliability check was not performed every 6 months

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

The test was performed in 2005 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods".

Test material

Test material information

Constituent 1

Reference substance name:

Glycine, N-methyl-, N-coco acyl derivs., sodium salts

EC Number:

263-193-2

EC Name:

Glycine, N-methyl-, N-coco acyl derivs., sodium salts

Cas Number:

61791-59-1

Molecular formula:

unspecified, UVCB substance

Test material form:

not specified

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 4179278

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: 12 months

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: SPF albino Crl:HA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Females nulliparous and non-pregnant: yes
- Weight at study initiation: 336 - 389 g
- Housing: 2 or 3 animals per cage in macrolone cages, softwood sawdust bedding
- Diet: Altromin 3122 pelleted, Altromin, Lage, Lippe, Germany, ad libitum
- Water: domestic quality water, Vitamin C enriched, acidified to pH 2.5 with hydrochloric acid, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

1st induction: 100%
2nd and 3rd induction: 75%

Day(s)/duration:

0 - 14

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

50%

Day(s)/duration:

28

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

10 (controls), 20 (in test group)

Details on study design:

RANGE FINDING TESTS: Preliminary irritation investigations were performed with two other animals to determine suitable concentrations for the induction and challenge application. Concentrations of the test item used were 25, 50, 75 and 100%. Based on the results, a concentration of 100% and 75% was selected for the induction phase and of 50% for the challenge phase.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test material in water
- Control group: water
- Site: left flank
- Frequency of applications: every 7 days
- Duration: Days 0 – 14
- Concentrations: 100 and 75%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 h
- Test groups: test material in water and water
- Control group: test material in water and water
- Site: anterior part of the right flank (test substance) and posterior part of the right flank (vehicle)
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h after patch removal

Challenge controls:

The control group is actually a challenge control.

Positive control substance(s):

no

Results and discussion

Positive control results:

The latest positive control study was performed in 2002. The positive control substance (100% alpha-hexylcinnamaldehyde) induced 65% positive responses, thus meeting the reliability criteria for the Buehler test (≥ 15% positive response). However, positive control studies shall be performed every six months according to OECD Guideline 406. Thus, the positive control study does not comply with the OECD Guideline 406.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

Induction 0%; challenge: 50%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

Induction: 100% and 75%; challenge: 50%

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Results 3

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

Induction: 0%; challenge: 50%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Results 4

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

Induction: 100% and 75%; challenge: 50%

No. with + reactions:

1

Total no. in group:

20

Clinical observations:

Slight or discrete erythema

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Executive summary:

.