7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate

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)

Rationale for reliability incl. deficiencies:

other: GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

Husbandry: Relative humidity in the animal room was 45-92% for about 10 hours.

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate

EC Number:

276-957-5

EC Name:

7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate

Cas Number:

72869-86-4

Molecular formula:

C23H38N2O8

IUPAC Name:

7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate

Details on test material:

Batch No. 81106228

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

10, 25. 50 % PC-Cure P-1001 in dimethylformamide

No. of animals per dose:

4

Details on study design:

Vehicle and Dose Selection
A solubility experiment was performed according to the recommendations given by OECD
429. The highest test item concentration, which can be technically used was a 50 % (w/w)
solution in dimethylformamide. Vortexing and warming to 37°C for about 10 minutes were
necessary to dissolve the test item.
To determine the highest non-irritant test concentration, a pre-test was performed in two
animals. Two mice were treated with concentrations of 25 and 50% each on three
consecutive days.
In the pre-test clinical signs were recorded within 1 hour and 24 ± 4 hours after each
application as well as on day 8. At the tested concentrations the animals did not show any
signs of irritation or systemic toxicity.
The test item in the main study was assayed at 10, 25 and 50%. The top dose is the
highest technically achievable concentration whilst avoiding systemic toxicity and
excessive local irritation. No severe irritant effects were tolerated choosing the test
concentrations.

Each test group was treated by topical application to the dorsal surface of each ear lobe with different test item concentrations. The application volume 25 microL was spread over the dorsal surface once daily for three consecutive days. Five days after the first application, all mice were administered with 250 microL of 3HTdR by intravenous injection. Five hours after treatment with 3HtdR all mice were euthanised and the draining lymph nodes were rapidly excised and pooled per group.

Positive control substance(s):

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

Results and discussion

Positive control results:

EC3 = 7.8 % (w/v)

In vivo (LLNA)

Results

Results 1

Parameter:

SI

Remarks on result:

other: 0%: 1.00 10%: 1.58 25 %: 1.70 50%: 4.44

Results 2

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: group 1 (0%): 6433 DPM group 2 (10%): 10151 DPM group 3 (25%): 10929 DPM group 4 (50 %): 28518 DPM

Applicant's summary and conclusion

Interpretation of results:

sensitising

Remarks:

Migrated information

Conclusions:

The test item PC-Cure P-1001 was found to be a skin sensitiser. The EC 3 value was calculated as 36.9%.

Executive summary:

The test item PC-Cure P-1001 was found to be a skin sensitiser. The EC 3 value was calculated as 36.9%.