Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

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.

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
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
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
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
oral: feed
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
Clinical signs:
no effects observed
Mortality:
no mortality observed
Haematological findings:
no effects observed
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
Key result
Critical effects observed:
not specified
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
510 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
low because of weak documentation

Additional information

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.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Study is clearly described and without contradictions, however with weak documentation

Justification for classification or non-classification

Up to 510 mg/kg no effect was observed.