Registration Dossier
Registration Dossier
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EC number: 260-690-6 | CAS number: 57352-34-8
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
Data source
Reference
- Reference Type:
- other: HPVIS
- Title:
- Repeated dose oral toxicity study for the test chemical Methane sulphonic acid
- Author:
- United States Environmental Protection Agency
- Year:
- 2 016
- Bibliographic source:
- United States Environmental Protection Agency, 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: AS mention belpw
- Principles of method if other than guideline:
- Repeated dose oral toxicity study was performed for the tets chemical Methane sulphonic acid using male/female Wistar rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- 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
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Methane sulphonic acid
- Molecular formula ;CH4O3S
- Molecular weight ; 96.1056 g/mol
- Substance type: Organic
-Purity;98%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Harlan Industries, Cumberland
- Age at study initiation: 30 days
- Weight at study initiation: 84 to 147 g (males) and 79 to 130 g (females)
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%): No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: distilled water then mixed with food
- Details on oral exposure:
- Details on oral exposure
PREPARATION OF DOSING SOLUTIONS: No data available
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data available
- Concentration in vehicle: 0.043%, 0.159%, 0.382% and 1.635% (for males) and 0.045%, 0.183%, 0.479% and 1.80% (for females)
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 7 days
- Frequency of treatment:
- Ad libitum
Doses / concentrations
- Remarks:
- Males: 0, 51, 185, 420, 1805 mg/kg bw/d;
Females: 0, 55, 201, 551, 2122 mg/kg bw/d
- No. of animals per sex per dose:
- 5 rats / dose (except 3 rats / lower dose)
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- No data available
- Positive control:
- Not specified
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
-Clinical signs: yes (at least once a day)
-Mortality: yes (at least twice a day)
-Body weight: yes (three times during the week)
-Food co nsumption: yes (no data about frequency)
-Water consumption: no data
-Ophthalmoscop ic examination: no
-Haematology: no
-Biochemistry: no
-Urinalysis: no - Sacrifice and pathology:
- -Macroscopic examined and weighted organs: liver and kidneys
-Microscopic: none
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No relevant changes in terms of doses were noted
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 805 other: mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant effect observed at this dose
- Remarks on result:
- other: No toxic effect observed
- Dose descriptor:
- NOAEL
- Effect level:
- 2 122 other: mg/Kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No significant effect were observed at this dose
- Remarks on result:
- other: No toxic effet observed
Target system / organ toxicity
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) was considered to be 1805 mg/kg/day for males and 2122 mg/kg/day for females respectively for Methane sulphonic acid(75-75-2) by oral feed.
- Executive summary:
Repeated dose oral toxicity study was performed for the tets chemical Methane sulphonic acid using male/female Wistar rats in a 7 days study.None of the rats orally exposed to methane sulfonic acid (up to 1800 mg/kg/day) died during the 7-day study. Furthermore, none of the measured parameters (food consumption, body weight change, liver and kidney weight) was affected by the exposure. Consequently, NOAEL can be valued at 1805 mg/kg/day for males and 2122 mg/kg/day for females respectively for Methane sulphonic acid by oral feed.
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