Sodium 2-methylprop-2-ene-1-sulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2103

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 2-methylprop-2-ene-1-sulphonate

EC Number:

216-341-5

EC Name:

Sodium 2-methylprop-2-ene-1-sulphonate

Cas Number:

1561-92-8

Molecular formula:

C4H8O3S.Na

IUPAC Name:

sodium 2-methylprop-2-ene-1-sulfonate

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): sodium methallylsulfonate
- Substance type: organi
- Physical state: solid crystalline
- Analytical purity: >=99.8%
- Isomers composition:
- Purity test date: see
- Lot/batch No.: SD29052012/DD230312/LNR20120120
- Expiration date of the lot/batch: indeterminate
- stability under test conditions: stable
- Storage condition of test material: normal lab conditions
-

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:vCharles River Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: males 288 gr , females 190 gr (average)

ENVIRONMENTAL CONDITIONS
Animal husbandry
Conditions
Environmental controls for the animal room were set to maintain 18 to 24°C, a relative humidity of 40
to 70%, approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any
variations to these conditions were maintained in the raw data and had no effect on the outcome of the
study.
Accommodation
Individually housed in labeled Makrolon cages (MIII type, height 18 cm.) containing sterilized sawdust
as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri,
Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions. During
the acclimatization period the animals were group housed in Makrolon cages (MIV type, height 18
cm).
Diet
Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
Water
Free access to tap water.
Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed
according to facility standard procedures.
There were no findings that could interfere with the study.

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Method Dermal application.
Clipping One day before exposure (Day -1) an area of approximately 5x7 cm on
the back of the animal was clipped.
Application The formulation was applied in an area of approx. 10% of the total body
surface, i.e. approx. 25 cm² for males and 18 cm² for females. The
formulation was held in contact with the skin with a dressing, consisting of
a surgical gauze patch (Surgy 1D)*, successively covered with aluminum
foil and Coban elastic bandage*. A piece of Micropore tape* was
additionally used for fixation of the bandages in females only.
*. Manufacturers: Laboratoires Stella s.a., Liege, Belgium (surgical gauze) and 3M, St. Paul,
Minnesota, U.S.A. (Coban & Micropore).
Frequency Single dosage, on Day 1.
Dose level (volume) 2000 mg/kg (10 mL/kg) body weight.
Application period 24 hours, after which dressings were removed and the skin cleaned of
residual test substance using tap water.

Duration of exposure:

24 hrs

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 / 5

Control animals:

not required

Details on study design:

Observations
Mortality/Viability Twice daily.
Body weights Days 1 (pre-administration), 8 and 15.
Clinical signs At periodic intervals on the day of dosing (Day 1) and once daily
thereafter, until Day 15. The time of onset, degree and duration were
recorded and the symptoms graded according to fixed scales:
Final Report
Sodium methallylsulphonate Project 500480
- Page 10 -
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).
Necropsy At the end of the observation period, all animals were sacrificed by
oxygen/carbon dioxide procedure and subjected to necropsy.
Descriptions of all internal macroscopic abnormalities were recorded.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD0

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD0

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: Chromodacryorrhoea was noted in two males and two females on Day 1. Scales were seen in the treated skin-area of two males and one female between Days 3 and 7.

Gross pathology:

none

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

sodium methallylsulfonate, tested in an acute dermal toxicity test, was found to have an LD0 of >= 2000 mg/kg bw