N-benzylprop-2-enamide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 February 2007 to 19 March 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

1

Reference substance name:

-

EC Number:

473-370-8

EC Name:

-

Cas Number:

13304-62-6

Molecular formula:

C10 H11 N O

IUPAC Name:

N-benzylprop-2-enamide

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River France, Larbresle Cedex, France
- Strain: CBA(inbred, SPF quality)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: ca 11 weeks
- Weight at study initiation: 20-26 g
- Housing: Individual (Macrolon MI) saw dust bedding
- Diet: Pelleted Rodent Diet ad libitum (SM R/M-Z SSNIFF Soest Germany)
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6-23.3 ˚C
- Humidity (%): 39-63%
- Air changes (per hr): ca 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

10, 25 and 50%

No. of animals per dose:

5 females

Details on study design:

PRE-SCREEN TESTS: 1 male/concentration
- Concentrations: 50% (maximum technically possible), 25%
- Irritation: none
- Systemic toxicity: none
- Ear thickness measurements: not performed
- Erythema scores: 0

MAIN STUDY : concentrations selected 10, 25 and 50%

Statistics:

NA

Results and discussion

Positive control results:

Test with Alpha-Hexylcinnamic Aldehyde tech 85% (5, 10 and 25% in acetone/olive oil (4/1)) was performed in Sepetmber 2006.
SI 6.2, EC3 13.1%

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

0.5

Test group / Remarks:

10%

Results 2

Parameter:

SI

Value:

0.6

Test group / Remarks:

25%

Results 3

Parameter:

SI

Value:

0.6

Test group / Remarks:

50%

Results 4

Parameter:

EC3

Value:

> 50

Cellular proliferation data / Observations:

CLINICAL OBSERVATIONS: none

BODY WEIGHTS: within expected ranges

ERYTHEMA/OEDEMA: none

LYMPHNODES SIZE: within normal ranges

LYMPHNODES ABNORMALITIES: none

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not sensitizing to the skin

Executive summary:

In a local lymphnode assay the dorsal ear of 5 females was treated with the substance at 10, 25 and 50% concentrations in dimethylformamide. After an injection on day 6 with 3H-methylthymidine, animals were killed, the lymphnodes were excised and investigated for abnormalities. Radioactivity of the lymphnodes (pooled per animal) was assessed by scintillation counting.

No increase of radioactivity compared to vehicle controls was observed. SI values were 0.5, 0.6 and 0.6 at 10, 25 and 50%. The EC3 value is > 50%.

The substance is not considered to be sensitizing to the skin.