4-methyl-salicylamide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

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:

other: ICCVAM, NIH publication no 99-4494, february 1999

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: crystalline

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

12 nulliparous and non-pregnant females

Study design: in vivo (LLNA)

Vehicle:

propylene glycol

Concentration:

dose 1: 1%
dose 2: 10%
dose 3: 50%

No. of animals per dose:

3

Details on study design:

observations:
mortality/viability: twice daily
toxicity: at least once daily
body weights: on days 1 (pre-treatment) and 6
irritation: on day 3 (3-4hours after treatment), the skin reactions were assessed.

Positive control substance(s):

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

Results and discussion

Positive control results:

An EC3 value of 8.8% was calculated.

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Value:

0.8

Test group / Remarks:

Dose 1

Results 2

Parameter:

SI

Value:

0.6

Test group / Remarks:

Dose 2

Results 3

Parameter:

SI

Value:

1

Test group / Remarks:

Dose 3

Results 4

Parameter:

SI

Value:

1

Test group / Remarks:

Vehicle control

Results 5

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: Mean DPM: Dose 1: 199 Dose 2: 133 Dose 3: 228 Vehicle control: 235

Any other information on results incl. tables

Macroscopy: Some of the nodes were reduced in size while others were enlarged when compared to normal. Red nodes (vehicle control Notox Project 366762) or red spots on some of the nodes were noted. No other macroscopic abnormalities of the nodes were noted.

Toxicity/Mortality: No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.

Body Weights: bBdy weights and body weight gain of experimental animals remained in the same range as controls over the study period.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Based on the fact that there was no indication that the test substance could elicit a SI>=3, and according to OECD and EC criteria for testing of Chemicals (OECD No.429 and EC B.42, draft), the test substance does not have to be classified and has no obligatory labeling requirement for sensitisation by skin contact.