Glycine, N, N' - (1,9-nonandeiyl) bis-, monopotasium salt

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

yes

Remarks:

The relative humidity in the animal room was between approximately 30-82%. This deviation to the study plan, however, did not affect the validity of the study

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

470-270-6

EC Name:

-

Cas Number:

477773-67-4

Molecular formula:

C13H22N2O6K

IUPAC Name:

Glycine, N, N' - (1,9-nonandeiyl) bis-, monopotasium salt

Test material form:

solid

In vivo test system

Test animals

Species:

mouse

Strain:

CBA/Ca

Sex:

female

Details on test animals and environmental conditions:

Source: Harlan Netherlands
Age: 7-8 weeks
Identification: Single caging. The animals were distributed into the test groups at random and identified by cage number.

Acclimatization: Under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
Housing: single

Diet : Pelleted standard diet, ad libitum

Water: tap water from ad libitum.

ENVIRONMENTAL CONDITIONS:
Temperature: 22 ± 3 °C
Relative humidity: 30 - 82%
artifical light 6.00 am - 6.00 pm

Study design: in vivo (LLNA)

Vehicle:

other: ethanol:deionised water at a rate 7:3

Concentration:

2,5 - 5 and 10%

No. of animals per dose:

4

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

A statistical analysis and standard deviations were calculated in the body weight tables

Results and discussion

Positive control results:

STIMULATION INDICES
2.04 (test item concentration 5% w/v) *
6.31 (test item concentration 10% w/v) *
12.45 (test item concentration 25% w/v)

EC3= 6.1%(w/v)

* This value was used in calculation of EC3

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Remarks:

test item concentration % (w/v) 2.5

Value:

ca. 1.4

Results 2

Key result

Parameter:

SI

Remarks:

test item concentration % (w/v) 5

Value:

ca. 0.89

Results 3

Key result

Parameter:

SI

Remarks:

test item concentration % (w/v) 10

Value:

ca. 1.14

Cellular proliferation data / Observations:

Mortatlity / Viability: once daily (week day) from experimental start to necroposy
Body weights: prior to the first application and prior to treatment with 3HTdR
Clinical signs (local/systemic): once daily (week day). Especially the treatment sites were observed carefully

Any other information on results incl. tables

Stimulation Indices of 1.40, 8.89 and 1.14 were determined with the test item at concentrations of 2.5, 5 and 10 % in ethanol: water at a rate of 7:3. The EC3 value could not be calculated, since none of the tested concentrations induced an SI grater than 3.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not a skin sensitiser.