(2,2-dimethyl-1,3-dioxolan-4-yl)methyl methacrylate

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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:

(2,2-dimethyl-1,3-dioxolan-4-yl)methyl methacrylate

EC Number:

230-408-6

EC Name:

(2,2-dimethyl-1,3-dioxolan-4-yl)methyl methacrylate

Cas Number:

7098-80-8

Molecular formula:

C10H16O4

IUPAC Name:

(2,2-dimethyl-1,3-dioxolan-4-yl)methyl 2-methylprop-2-enoate

Test material form:

liquid

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS B.V., Inc. Postbus 6174 5960 AD Horst / The Netherlands
- Age at study initiation: 1st pre-test: 11 - 12 weeks 2nd pre-test: 10 - 11 weeks 3rd pre-test and main study: 9 - 10 weeks
- Weight at study initiation:
- Housing: group (Makrolon Type II (pre-test) / III (main study), with wire mesh top
- Diet (e.g. ad libitum): 2018C Teklad Global 18% protein rodent diet (certified), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days prior

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 45 -65
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

1, 2.5 and 5% (w/w)

No. of animals per dose:

5

Positive control substance(s):

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

Statistics:

The mean values and standard deviations were calculated in the body weight tables, for the ear weights, the lymph node weights and lymph node cell count, and for the DPM values (group mean DPM ± standard deviation).
All calculations conducted on the DPM values, the ear weights, the lymph node weights and the lymph node cell count were performed with validated program R Script STABW-mitStat.Rnw.
Within the program a statistical analysis was conducted on the DPM values, the ear weights, the lymph node weights and the lymph node cell count to assess whether the difference was statistically significant between the test item groups and negative control group. Statistical significance was set at the five per cent level (p < 0.05). Additionally, the Dean-Dixon-Test and Grubb’s Test were used for identification of possible outliers. No outlier values were detected.

Results and discussion

In vivo (LLNA)

Results

Remarks on result:

other: The EC3 value could not be calculated, since all S.I:`s are below the threshold value of 3

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item Isopropylidenglycerolmethacrylate (IPGMA) was not a skin sensitiser under the test conditions of this study.