Sodium 3-(allyloxy)-2-hydroxypropanesulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 May - 10 July 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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 - liquid: aqueous solution

Details on test material:

light yellow liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER (53840 Le Genest St Isle- France)
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: 245 to 271 g (males); 223 to 240 g (females)
- Housing: group, polycarbonate cages with steinless steel mesh lid
- Diet: M20-SDS ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10% of the body surface
- Type of wrap if used: gauze dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4.32 ml /kg, equal to 5235 mg/kg bw
the amount applied was calculated based on the density and the concentration of HAPS in the test item

VEHICLE
none

Duration of exposure:

24 hours

Doses:

5235 mg/kg bw (equivalant to 2000 mg/kg compound)

No. of animals per sex per dose:

5 rats/per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily, weighing on day 0, 2, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

mean and standard deviation of body weights

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 235 mg/kg bw

Based on:

test mat.

Remarks on result:

other: as aqueous solution

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

solid

Mortality:

no mortality observed

Clinical signs:

other: no systemic clinical sign was observed. Erythema was noted from 24 hours post-dose in all animals and was totally reversibel on day 7. Scabs were noted in all animals from 48 hours post-dose and remained on day 14 in all animals.

Gross pathology:

no treatment related changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The study is well performed and gives following results for the Endpoint:
LD 50 (dermal route) > 5235 mg/kg bw to testmaterial (aqueous solution)
LD 50 (dermal route) > 2000 mg/kg bw solid sodium 3-(allyloxy)-2-hydroxypropanesulphonate)

Executive summary:

At the request of the sponsor, the test item sodium 3-(allyloxy)-2-hydroxypropanesulphonate) (HAPS) was applied onto the intact skin of 10 Sprague Dawlley rats (5 males and 5 females) at the single dose of 5235 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No. 402 dated February 24th, 1987 and the test method B.3 of the Council regulation No. 440/2008 of 30 May 2008.

No mortality occured during the study.

No systemic clincal sign related to the administration of the test item was observed.

Erythrema was noted from 24 hours post-dose in all animals and was totally reversible on day 7. Scabs were noted in all animals from 48 hours post-dose and remained on day 14 in all animals.

The body weight evolution of the animals remained normal throughout the study.

The macroscopcal examination of the animals at the end of the study did not reveal treatment-related changes.

In conclusion, the LD 50 of the test item sodium 3-(allyloxy)-2-hydroxypropanesulphonate) (HAPS) as -aqueous solution -is higher than 5235 mg/kg bodyweight by dermal route in the rat.

In conclusion, the LD 50 of the test item sodium 3-(allyloxy)-2-hydroxypropanesulphonate) (HAPS) as -solid -is higher than 2000 mg/kg bodyweight by dermal route in the rat.