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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limit test, predating OECD protocols and GLP. Yet study outcome sufficient for decision on classification

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: IRLG (1981)

Deviations:

no

Principles of method if other than guideline:

range-finding study in the rat. 250, 500, 2500 and 5000 mg/kg bw on 2 males and 2 females per group, oral, gavage.
in the absence of any mortality, 5000 mg/kg bw on 5 male, 5 female animals

GLP compliance:

no

Test type:

other: Limit test "avant la lettre"

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 - liquid: suspension

Remarks:

migrated information: dispersion

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton laboratories
- Age at study initiation: not given
- Weight at study initiation: 190-210 gr (males; 185-195 gr (females)
- Fasting period before study: overnight
- Housing: caged singly in Makrolon cages
- Diet (e.g. ad libitum): at lib
- Water (e.g. ad libitum): at lib
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 40-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: September To: October (dates not specified)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

range-finding: 250, 500, 2500 and 5000mg/kg bw . Limit test: 5000 mg/kg bw

No. of animals per sex per dose:

range finding: 2/2, final study 5/5

Control animals:

no

Statistics:

not applicable

Results and discussion

Preliminary study:

range-finding study in the rat. 250, 500, 2500 and 5000 mg/kg bw on 2 males and 2 females per group, oral, gavage.
No mortality, no clinical effects

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD0

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD0

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: lethargy from 30 minutes to one and and a half hour after dosing in 2 males and 2 females

Gross pathology:

none

Other findings:

none

Any other information on results incl. tables

body weights during recovery

Dose (mg/kg)	animal nr Nr. , gender	Tag-1	Tag1	Tag8	Tag 1 5
5000	1, m	225	200	280	350
	2, m	210	190	260	300
	3,m	225	210	290	345 /
	4,m	220	' 205	275	325
	5, m	210	190	275	310 -
	6 ,f	200	1 85	215	225
■	7,f	210	190	225	240
	8,f	205	'1 95	280	330
	9,f	190	1 85	230	260
-	10, f	205	1 95	2 30	230

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

non toxic

Executive summary:

Based on the results of the range-finding study, 10 sprague=dawley rats (5m, 5f) were given 5000 mg/kg bw, suspended in water by gavag of sodium mehtally sulphonate.

in 4/10 animals, a brief period of lethargy shorty after dosing was observed

Since all animals survived the 14 -day recovery period, the LD0 can be set at =5000 mg/kg bw.

No gross pathology was observed at obduction