Sodium 2-hydroxyethanesulphonate

Endpoint summary

Description of key information

The sensitization potential of Sodium 2-hydroxyethanesulphonate was investigated according to OECD Guideline 429 and found to be not a skin sensitiser under the described conditions.

 

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:

2008-05-20 till 2008-06-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline-conform study under GLP without deviations

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)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 19.3 +/- 0.7 (Group 1), 20.2 +/- 0.3 (Group 2), 19.5 +/- 0.3 (Group 3), 18.9 +/- 1.2 (Group 4)
- Housing: Single caging. Cage type: Makrolon Type I, with wire mesh top
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water from Rossdorf, ad libitum
- Acclimation period: At least 5 days prior to the start of dosing


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 / 12

Vehicle:

other: ethanol: deionised water (30:70)

Concentration:

10%, 25%, 50%

No. of animals per dose:

5 females per dose

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: The highest test item concentration, which can be technically used was a 50 % solution in ethanol:deionised water (30:70).
With other vehicles used, equivalent concentrations could not be achieved.
- Irritation: performed on two female mice, by topical application of concentrations of 5, 10, 25, and 50 % on one ear each on three consecutive days.
The animals did not show any signs of irritation or systemic toxicity.


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay (LLNA)
- Criteria used to consider a positive response: The sensitivity and reliability of the experimental technique employed was assessed by use of a
substance which is known to have skin sensitisation properties in CBA/CaOlaHsd mice (¿-Hexylcinnamaldehyde in acetone:olive oil, 4:1 )


TREATMENT PREPARATION AND ADMINISTRATION:
25 µl was spread to the entire dorsal surface of each ear of each mouse once daily for three consecutive days. On day 6 an injection of 250 µl phosphate buffered saline (PBS) containing 78.9 µCi of 3H-methyl thymidine (3H-TdR) was made into the tail vein of each experimental mouse. Five hours
later, the draining Auricular lymph node of each ear was excised into PBS. A single cell suspension of lymph node cells was prepared from each
mouse. After washing two times with phosphate buffered saline the lymph node cells were resuspended in 5 % trichloroacetic acid and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid
and transferred to plastic scintillation vials. The level of 3HTdR incorporation was then measured on a ¿-scintillation counter.

Positive control substance(s):

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

Statistics:

No data.

Positive control results:

The sensitivity and reliability of the experimental technique employed was assessed by use of a substance which is known to have skin sensitisation properties in CBA/CaOlaHsd mice.

Parameter:

SI

Remarks on result:

other: see Remark

Remarks:

Stimulation Indices (S.I.) of 0.46, 0.48, and 0.56 were determined with the test item at concentrations of 10, 25, 50 % in ethanol:deionised water (30+70), respectively. The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: See table 1

Key result

Parameter:

SI

Remarks:

10 % test item

Value:

>= 0.46

Test group / Remarks:

10 %

Remarks on result:

other:

Remarks:

not sensitising

Key result

Parameter:

SI

Remarks:

25 % tets item

Value:

>= 0.48

Test group / Remarks:

25 % test item

Remarks on result:

other:

Remarks:

not sensitising

Key result

Parameter:

SI

Remarks:

50 % test item

Value:

>= 0.56

Test group / Remarks:

50 tets item

Remarks on result:

other:

Remarks:

not sensitising

Interpretation of results:

not sensitising

Conclusions:

The test item Sodium 2-hydroxyethanesulphonate was found to be not a skin sensitiser under the described conditions.

Executive summary:

The sensitization potential was investigated according to OECD Guideline 429.

The test item concentrations choosen for the LLNA test were 10, 25, 50 %.

No deaths occurred during the study period. No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period. The body weight of the animals was within the range commonly recorded for animals of this strain and age.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Skin sensitising potential of Sodium 2-hydroxyethanesulphonate was tested in one Local Lymph Node Assay (LLNA) according to OECD test guideline 429. In this assay S.I. of 0.46, 0.48 and 0.56 were determined with the test item at concentrations of 10%, 25% and 50% in ethanol:deionised water, 30:70.

In this assay no EC3 value could be calculated since all S.I. values were below 3.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

There are no respiratory sensitization properties of the substance known in literature. Beyond this there are no indications of sensitization property of the compound from the LLNA study. Therefore, it is concluded that the subsance is not a respiratory sensitizer.

Justification for classification or non-classification

Sodium 2-hydroxyethanesulphonate did not show skin sensitizing properties in the LLNA study according to the current OECD guidelines. Allergic skin reactions or case reports of acute contact dermatitis to Sodium 2-hydroxyethanesulphonate have not been described in the literature. Therefore, the substance does not have to be classified as a skin sensitizer.

 

A classification concerning respiratory sensitizing properties is not warranted as the classification criteria according to EU regulation 1272/2008 are not met.