Sodium 3-(allyloxy)-2-hydroxypropanesulphonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 May 2012 - 20 June 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (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:

Sodium 3-(allyloxy)-2-hydroxypropanesulphonate

EC Number:

258-004-5

EC Name:

Sodium 3-(allyloxy)-2-hydroxypropanesulphonate

Cas Number:

52556-42-0

Molecular formula:

C6H12O5S.Na

IUPAC Name:

sodium 2-hydroxy-3-(prop-2-en-1-yloxy)propane-1-sulfonate

additive 1

Reference substance name:

Sodium hydroxide

EC Number:

215-185-5

EC Name:

Sodium hydroxide

Cas Number:

1310-73-2

Molecular formula:

HNaO

IUPAC Name:

sodium hydroxide

impurity 1

Reference substance name:

3-(allyloxy)propane-1,2-diol

EC Number:

204-620-4

EC Name:

3-(allyloxy)propane-1,2-diol

Cas Number:

123-34-2

Molecular formula:

C6H12O3

IUPAC Name:

3-(allyloxy)propane-1,2-diol

impurity 2

Reference substance name:

disodium 2-hydroxy-3-(3-sulfonatopropoxy)propane-1-sulfonate

Molecular formula:

C6H12Na2O8S2

IUPAC Name:

disodium 2-hydroxy-3-(3-sulfonatopropoxy)propane-1-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

light yellow powder

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst / The Netherlands
- Age at study initiation: 8-9 weeks (pretest) 9-10 weeks (main study)
- Weight at study initiation: 19.65 (pretest) 21.0+-1.6 (main study)
- Housing: group; Makrolon Type II (pretest) /III (main study) cages
- Diet: 2018C Teklad Global 18% protein rodent diet, ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2 °C
- Humidity (%): 45-65%
- Air changes (per hr): no date
- Photoperiod (hrs dark / hrs light): 12

Study design: in vivo (LLNA)

Vehicle:

other: ethanol:water (3+7 v/v)

Concentration:

pretest: 25 %, 50 %
main study: 0 %, 5 %, 10 %, 25 %

No. of animals per dose:

pretest: 1
main study: 4

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: up to 50 % in vehicle, higher concentrations were not reachable
- Irritation: at 50 % test item concentration, erythema and swelling of the ear was observed

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: determination of incorporated 3HTdR
- Criteria used to consider a positive response: 1) the test item causes an incorporation of 3HTdR at least 3-fold or greater compared to the control, as indicated by the stimulation index.
2) the data are compatible with a conventional dose response, although allowance must be made for either local toxicity or immunological suppression.

TREATMENT PREPARATION AND ADMINISTRATION:
The test item was placed into a volumetric flask on a tared balance and ethanol:water (3+7, v/v) was quantitatively added.
Each test group of mice was treated by topical application to the dorsal surface of each ear. The application volume, 25 µl/ear/day, was spread over the entire dorsal surface of each ear.

Positive control substance(s):

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

Statistics:

mean values and standard deviations were calculated for the body weights

Results and discussion

Positive control results:

Historical Data (Results of the GLP Positive Control, April 2012):
25% in acetone:olive oil (4+1 v/v): S.I.: 3.73

In vivo (LLNA)

Results

Results 1

Key result

Parameter:

SI

Remarks on result:

other: control: 1.0 5%: 0.69 10%: 0.87 25%: 0.56

Results 2

Key result

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: control: 1438 5%: 990 10%: 1254 25%: 805

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item Sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) was not a skin sensitiser under the test conditions of this study.

Executive summary:

In the study the test item Sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) dissolved in ethanol:water (3+7, v/v) was assessed for its possible skin sensitising potential.

For this purpose a local lymph node assay was performed using test item concentrations of 5, 10 and 25% (w/v). The highest concentration tested was the highest concentration that could be achieved whilst avoiding systemic toxicity and excessive local skin irritation as confirmed by a pre-experiment.

The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. In this study Stimulation Indices (S.I.) of 0.69, 0.87 and 0.56 were determined with the test item at concentrations of 5, 10 and 25% (w/v) in ethanol:water (3+7, v/v), respectively. A dose response was not observed.

The test item Sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) wasnot a skin sensitiserunder the test conditions of this study.