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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Remarks:
other: 4 week toxicity study by oral route (gavage) in rats
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP. Guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 424 (Neurotoxicity Study in Rodents)
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
yes (incl. QA statement)
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
456-160-0
EC Name:
-
Cas Number:
73942-87-7
Molecular formula:
C12H13NO3
IUPAC Name:
7,8-dimethoxy-2,3-dihydro-1H-3-benzazepin-2-one

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: solution: 0,5% methylcellulose
Duration of treatment / exposure:
28 d
Frequency of treatment:
7day/week
No. of animals per sex per dose:
5 Males and 5 Females: 0 mg/kg/day
5 Males and 5 Females: 15 mg/kg/day
5 Males and 5 Females: 150 mg/kg/day
5 Males and 5 Females: 300mg/kg/day

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
300 mg/kg bw/day (nominal)
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No unscheduled deaths occurred during the study.

Ptyalism is commonly observed in rats tereated by gavage, it was not considered to be of toxicological importance.

Alopecia, chromodacryorrhea, chromorhinorrhea and abnormal growth of teeth were observed in some control and treated animals.

No evidence of perturbation of either autonomic or physiological functions at any time or at any of the dose-levels tested.

No relevant changes in neurotoxicological parameters or motor activity in any treated animal.

Applicant's summary and conclusion

Conclusions:
Ptyalism was noted in all test-treated groups.
No revelant changes at clinical, laboratory or pathological investigations were seen in any test- treated groups.
Under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) of the test item is considered to be 300 mg/kg/day