Registration Dossier
Registration Dossier
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EC number: 257-851-8 | CAS number: 52328-05-9
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Feedingstudy;
Check of Body weight, food intake, behaviour, survival
Examination of liver, kidneys, spleen - GLP compliance:
- no
Test material
- Reference substance name:
- Bis(2-methylisouronium) sulphate
- EC Number:
- 257-851-8
- EC Name:
- Bis(2-methylisouronium) sulphate
- Cas Number:
- 52328-05-9
- Molecular formula:
- C4H14N4O6S
- IUPAC Name:
- O-methyl-isourea sulphate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 mg/kg diet
- Dose / conc.:
- 1 500 mg/kg diet
- Dose / conc.:
- 7 500 mg/kg diet
- Dose / conc.:
- 15 000 mg/kg diet
- No. of animals per sex per dose:
- 10
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Haematological findings:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- ca. 510 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Key result
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- the NOEL of O-Methylisourea sulphate was 510mg/kg in male rat and 530 mg/kg in female rats
- Executive summary:
O-Methylisourea sulphate was administred with feed to male and female albino rats.
General conditions, behaviour and survival were not adversly affected by the feeding of the test substance
Body weights, food intake and food efficiency were decreased at the 1.5% level in both exes.
No distinct differences in haemoglobin content werde observed between the various groups
Gross examination at autopsy and histological examination of liver, kidneys andspleen did not reveal any treatment-related abnormaities.
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