Sodium 3-(allyloxy)-2-hydroxypropanesulphonate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

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)

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

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

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

Key result

Parameter:

SI

Remarks on result:

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

Key result

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated from Short description of key information:
A LLNA in-vivo study has been performed and no effects were observed.

Justification for selection of skin sensitisation endpoint:
only one study available.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The presented substance has no indication for skin sensitisation and is therefore not a respiratory sensitiser either (REACH technical guidance document: scheme of R7A, Fig 7.3-2). In addition, the substance has a low volatility (<0.01 kPa).

Justification for selection of respiratory sensitisation endpoint:
no study available, conclusion is drawn from ECHA Guidance document (see Discussion)