Methanesulphonic acid

Repeated dose toxicity: oral

Administrative data

Endpoint:

repeated dose toxicity: oral

Remarks:

other: 7 days

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Peer-reviewed data, reliability according to US-EPA IUCLID data set.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

HPVIS, IUCLID Data Set for Methanesulphonic acid, CAS no. 75-75-2

Author:

US-EPA

Year:

2006

Bibliographic source:

HPV Chemicals Challenge Program OPPT CBIC 201-16750B

Reference 2

Reference Type:

review article or handbook

Title:

Methanesulfonic acid.

Author:

Shertzer HG

Year:

2001

Bibliographic source:

Patty's Toxicology, 5th edition, Vol 7, Ch. 94: 745-746

Materials and methods

Principles of method if other than guideline:

Four groups of 3-5 rats were fed diet containing Methanesulphonic acid (MSA) for 7 days at the target dose levels of 50, 200, 500 and 2000 mg/kg bw. Control animals received normal diet. Clinical signs, body weight and food consumption was determined.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methanesulphonic acid

EC Number:

200-898-6

EC Name:

Methanesulphonic acid

Cas Number:

75-75-2

Molecular formula:

CH4O3S

IUPAC Name:

methanesulfonic acid

Details on test material:

- Name of test material (as cited in study report): Methane sulfonic acid
- Physical state: liquid, mixed with food
- Analytical purity: 98 % anhydrous state
- Lot/batch No.: 8E29
- Other: Source: MCB, South Charleston, WV.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Industries, Cumberland
- Age at study initiation: 30 days
- Weight at study initiation: 84 - 147g (males), 79 - 130 g (females)
- Fasting period before study: unfasted
- Housing: 2 or 3 per cage
- Diet: ad libitum

Administration / exposure

Route of administration:

oral: feed

Vehicle:

water

Details on oral exposure:

PREPARATION OF DOSING SOLUTIONS:
Dilution with distilled water, then mixed with food

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

7 days

Frequency of treatment:

continuously

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
males 51, 185, 420, 1805 mg/kg bw/d; females: 55, 201, 551, 2122 mg/kg bw/d
Basis:
actual ingested

Doses / concentrations 2

Remarks:

Doses / Concentrations:
males: 0.043, 0.159, 0.382, 1.635 %; females: 0.045, 0.183, 0.479, 1.80 %
Basis:
nominal in diet

No. of animals per sex per dose:

5 (except 3/lower dose)

Control animals:

yes, plain diet

Examinations

Observations and examinations performed and frequency:

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least once per day

BODY WEIGHT: Yes
- Time schedule for examinations: three times during the week

FOOD CONSUMPTION: Yes (no data concerning frequency)

WATER CONSUMPTION: No data

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: No

CLINICAL CHEMISTRY: No

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No data

Sacrifice and pathology:

GROSS PATHOLOGY: yes
HISTOPATHOLOGY: No

Other examinations:

Mortality (at least twice a day), Liver and kidney weight (absolute and relative)

Statistics:

The results of weight changes were intercompared for the dosage groups by use of Bartlett's test for homogeneity of variance, by the analysis of variance and by Duncan's multiple range test. The latter was used, if F for the analysis of variance was significantly high, to delineate which groups differed from the others. If Bartlett's test indicated heterogeneous variances, the F-test was used for any paired-group comparison. If these individual F-tests were not significant, Student's t-test was used; if significant, the means were compared by the Cochran t-test. The fiducial limit of 0.05 was employed as the critical level of difference not believed to be produced by chance.

Results and discussion

Results of examinations

Details on results:

CLINICAL SIGNS AND MORTALITY
No mortality.

BODY WEIGHT AND WEIGHT GAIN
No significant variation.

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
No significant variation in food consumption. The compound intake for males in the target dose levels of 0, 50, 200, 500 and 2000 mg/kg bw were 51, 185, 420, 1805 mg/kg bw/d, respectively. The compound intake for females in the target dose levels of 0, 50, 200, 500 and 2000 mg/kg bw were 55, 201, 551, 2122 mg/kg bw/d, respectively.

ORGAN WEIGHTS
No relevant changes.

GROSS PATHOLOGY
Findings not reported.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

>= 1 805 mg/kg bw/day (actual dose received)

Sex:

male

2

Dose descriptor:

NOAEL

Effect level:

>= 2 122 mg/kg bw/day (actual dose received)

Sex:

female

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

None of the rats orally exposed to methane sulfonic acid (up to 2122 mg/kg bw/day) died during this 7-day study. Furthermore, none of the measured parameters was affected by the exposure.

Additionally, the potassium salt of methane sulfonic acid was investigated in this study up to 2080 mg/kg bw/day without effects, as well.