Sodium 4-vinylbenzenesulphonate

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:

16 to 22 March 2016

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)

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

other: CBA/CaOlaHsd mice

Sex:

female

Details on test animals and environmental conditions:

Species and strain: CBA/CaOlaHsd mice
Source: Envigo (formerly Harlan Laboratories S.r.l.) San Pietro al Natisone (UD)
Zona Industriale Azzida, 57, 33049 Italy
Hygienic level: SPF at arrival; standard housing conditions during the study
Justification of strain: On the basis of OECD Guideline, mice of CBA/Ca or
CBA/J strain can be used. Females are used because the existing database is predominantly based on females.
Number of animals: 4 animals / group
Sex: Female, nulliparous, non pregnant
Age of animals at starting: 8 weeks old (age-matched, within one week)
Body weight range at starting: 17.0 – 18.8 grams (The weight variation in animals in the study did not exceed  20 % of the mean weight.)
Acclimatization time: 7 days

Vehicle:

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

Concentration:

50, 25 and 10 % w/v

No. of animals per dose:

4 per dose

Details on study design:

Preliminary Irritation/Toxicity Test: Conducted on CBA/CaOlaHsd mice using two doses (2 animals/dose) at test item concentrations of 50 and 25 % (w/v) in 1% Pluronic.
The maximum concentration of test item in an acceptable solvent was established according to OECD guideline 429. Based on the observation of the solubility test, the maximum available concentration was 50 % (w/v).
In the Preliminary Irritation / Toxicity Test, all mice were observed daily for any clinical signs of systemic toxicity or local irritation at the application site. Both ears of each mouse were observed for erythema and scored. Ear thickness was also measured using a thickness gauge on Day 1 (pre-dose), Day 3 (approximately 48 hours after the first dose) and Day 6. Additional quantification of the ear thickness was performed by ear punch weight determination after the euthanasia of the experimental animals.
During the study, animals were topically dosed with 25 µL of the appropriate formulation using a pipette on the dorsal surface of each ear. Each animal was dosed once a day for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6.

Positive control substance(s):

other: 25 % HCA in AOO

Key result

Parameter:

SI

Remarks on result:

other: The stimulation index values were 0.9, 1.5 and 1.1 at concentrations of 50, 25 and 10 % (w/v), respectively. The stimulation index value of the positive control 25 % (w/v) HCA in AOO was 18.4

Key result

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: The DPM values were 288.4, 473.6 and 352.7 at concentrations of 50, 25 and 10 % (w/v), respectively. The DPM value of the positive control 25 % (w/v) HCA in AOO was 7236.4

No mortality or signs of systemic toxicity were observed during the study. There were no indications of any irritancy at the site of application. Test item precipitate or minimal amount of test item precipitate was observed on the ears of the animals in the 50 and 25 % (w/v) dose groups on Days 1-3.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay

Executive summary:

The skin sensitisation potential of the substance NaSS was assessed by means of the OECD 429 test Guideline in compliance with GLP. The highest achievable concentration based on the regulatory requirements of the OECD guideline and the physical characteristics of the test item was 50 %(w/v).

 

The Preliminary Irritation/Toxicity Test was performed in CBA/CaOlaHsd mice using two doses (2 animals/dose): 50 and 25 % (w/v) in 1% Pluronic. Based on the observations recorded in the preliminary test, the 50 % (w/v) was selected as top dose for the main test.

 

In the main assay, twenty female CBA/CaOlaHsd mice were allocated to five groups of four animals each:

-three groups received test sample (formulated in 1% Pluronic) at 50, 25 and 10 % (w/v)concentrations,

-the negative control group received the vehicle (1% Pluronic),

-the positive control group received 25 % (w/v) HCA (dissolved in AOO (acetone:olive oil 4:1 (v:v)mixture)).

 

The test item solutions were applied on the dorsal surface of ears of experimental animals (25 µL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. The cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices(SI).

 

No mortality or signs of systemic toxicity were observed during the study. There were no indications of any irritancy at the site of application. Test item precipitate or minimal amount of test item precipitate was observed on the ears of the animals in the 50 and 25 % (w/v) dose groups on Days 1-3. No treatment related effects were observed on the body weight changes of the experimental animals.

 

The stimulation index values were 0.9, 1.5 and 1.1 at concentrations of 50, 25 and 10 % (w/v),respectively.

 

The result of the positive control substance α-Hexylcinnamaldehyde (HCA) dissolved in AOO was used to demonstrate the appropriate performance of the assay. A lympho proliferative response in line with historic positive control data was noted for the positive control chemical, this result confirmed the validity of the assay.

 

In conclusion, under the conditions of the present assay, NaSS tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The skin sensitisation potential of the substance NaSS was assessed by means of the OECD 429 test Guideline in compliance with GLP. The highest achievable concentration based on the regulatory requirements of the OECD guideline and the physical characteristics of the test item was 50 %(w/v).

 

The Preliminary Irritation/Toxicity Test was performed in CBA/CaOla Hsd mice using two doses (2 animals/dose): 50 and 25 % (w/v) in 1% Pluronic. Based on the observations recorded in the preliminary test, the 50 % (w/v) was selected as top dose for the main test.

 

In the main assay, twenty female CBA/CaOla Hsd mice were allocated to five groups of four animals each:

-three groups received test sample (formulated in 1% Pluronic) at 50, 25 and 10 % (w/v)concentrations,

- the negative control group received the vehicle (1% Pluronic),

- the positive control group received 25 % (w/v) HCA (dissolved in AOO (acetone:olive oil 4:1 (v:v)mixture)).

 

The test item solutions were applied on the dorsal surface of ears of experimental animals (25 µL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. The cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices(SI).

 

No mortality or signs of systemic toxicity were observed during the study. There were no indications of any irritancy at the site of application. Test item precipitate or minimal amount of test item precipitate was observed on the ears of the animals in the 50 and 25 % (w/v) dose groups on Days 1-3. No treatment related effects were observed on the body weight changes of the experimental animals.

 

The stimulation index values were 0.9, 1.5 and 1.1 at concentrations of 50, 25 and 10 % (w/v),respectively.

 

The result of the positive control substance α-Hexylcinnamaldehyde (HCA) dissolved in AOO was used to demonstrate the appropriate performance of the assay. A lympho proliferative response in-line with historic positive control data was noted for the positive control chemical, this result confirmed the validity of the assay.

 

In conclusion, under the conditions of the present assay, NaSS tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

NaSS tested in a suitable vehicle, was shown to have no sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.