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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N-methyl-4-(p-formylstyryl)pyridinium methylsulfate
EC Number:
418-240-3
EC Name:
N-methyl-4-(p-formylstyryl)pyridinium methylsulfate
Cas Number:
74401-04-0
Molecular formula:
C16H17NO5S
IUPAC Name:
4-[2-(4-formylphenyl)ethenyl]-1-methylpyridin-1-ium methyl sulfate
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled water
Duration of treatment / exposure:
28 days
Frequency of treatment:
7 days/week
Doses / concentrationsopen allclose all
Dose / conc.:
150 mg/kg bw/day (nominal)
Dose / conc.:
400 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:
Mortality, clinical signs of toxicity, haematology
Sacrifice and pathology:
Necropsy with evaluation of gross and microscopic changes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
No signs of toxicity were observed.
Mortality:
no mortality observed
Description (incidence):
No deaths occurred
Haematological findings:
no effects observed
Description (incidence and severity):
There were no blood chemical changes that could be considered toxicologically significant.
Gross pathological findings:
no effects observed
Description (incidence and severity):
No treatment-related gross findings were observed.
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
No treatment-related microscopic findings were observed.

Effect levels

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
gross pathology
haematology
histopathology: non-neoplastic
mortality

Target system / organ toxicity

Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
NOAEL = 1000 mg/kg bw/day (nominal)
Executive summary:

A 28-days repeated dose toxicity study was performed via oral route on rats according to the EU Method B.7 (92/69/EEC) and in compliance with GLP. 0, 150, 400 and 1000 mg/Kg bw/day of the test substance were administerd via gavage to 5 females and 5 males per dose. No mortality occured and no signs of toxicity were observed. There were no blood chemical changes that could be considered toxicologically significant and no treatment-related gross microscopic findings were observed. Therefore, the NOAEL was found to be equal to 1000 mg/kg bw/day.