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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
to 1959-11-2
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report date:
1959

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Hoechst internal guideline
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-[4-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
EC Number:
263-418-4
EC Name:
4-[4-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
Cas Number:
62121-76-0
Molecular formula:
C20H20N4Na2O12S3
IUPAC Name:
4-[4-[[2,5-dimethoxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
Test material form:
solid

Test animals

Species:
rat
Strain:
other: mixed albino rats
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
not specified
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
18 , 20 days, respectively
Frequency of treatment:
14 times
Doses / concentrations
Dose / conc.:
500 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
not specified
Control animals:
not specified
Details on study design:
Post-exposure period: 2 days
Positive control:
NA

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: not specified

DETAILED CLINICAL OBSERVATIONS: No

BODY WEIGHT: No

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: Yes
- Time schedule for collection of blood: at beginning and end of the study
- Animals fasted: Not specified

CLINICAL CHEMISTRY: Not specified

URINALYSIS: Yes
- Time schedule for collection of urine: at beginning and end of the study
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: Not specified
.

NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No
Sacrifice and pathology:
GROSS PATHOLOGY: Yes

HISTOPATHOLOGY: Yes
Other examinations:
Faeces was examined.
Statistics:
no data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
not specified
Body weight and weight changes:
not examined
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
not specified
Urinalysis findings:
no effects observed
Behaviour (functional findings):
no effects observed
Immunological findings:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Neuropathological findings:
not examined
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
In some animals, a reversible fatty liver was observed.
Histopathological findings: neoplastic:
no effects observed
Other effects:
not specified
Details on results:
Faeces was stained by test item

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day (actual dose received)
Sex:
male
Basis for effect level:
histopathology: non-neoplastic

Applicant's summary and conclusion

Conclusions:
In this 14 day study, a NOAEL of the test item 500 mg/kg bw per day in rats was observed.
Executive summary:

In a subacute study, the test item diluted in water was administered to male mixed albino rats in water by gavage at a dose level of 500 mg/kg bw day.

No clinical signs were observed during the study. Blood and urine did not show any adverse effects. No gross pathological effects were observed. Histopathological findings were a fatty liver in some animals.

 

Information on quantity and statistical significance was not provided. Further examination on critical endpoints like body weight or organ weight was not specified.

 

Based on the lack of data, this study cannot be used for further risk assessment and is used as supporting information, only.