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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
no data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Although the internal study documents do not include a lot of details (e.g. vehicle is not know), there was a clear dose response curve, both in males and females. Therefore, the information in this study is used in weight of evidence with the available RCC study (Damme, 2001) with this substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Principles of method if other than guideline:
Although the internal study documents do not include a lot of details, a clear dose response curve, both in males and females was observed.
GLP compliance:
not specified
Test type:
other: No data

Test material

Constituent 1
Chemical structure
Reference substance name:
rel-(4aR,8aR)-1-bromo-3-methoxy-4a,5,9,10,11,12-hexahydro-6H-[1]benzofuro[3a,3,2-ef][2]benzazepin-6-one hydrochloride (1:1)
EC Number:
700-867-1
Molecular formula:
C16H16BrNO3.HCl
IUPAC Name:
rel-(4aR,8aR)-1-bromo-3-methoxy-4a,5,9,10,11,12-hexahydro-6H-[1]benzofuro[3a,3,2-ef][2]benzazepin-6-one hydrochloride (1:1)
Test material form:
solid
Details on test material:
- Name of test material (as cited in study reports): T002102
- Physical state: solid
- Appearance: white (SDS)

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
250 mg/kg bw, 500 mg/kg bw, 1000 mg/kg bw
No. of animals per sex per dose:
2 animals per sex and per dose
Control animals:
not specified
Details on study design:
No data
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
500 mg/kg bw
Based on:
test mat.
95% CL:
309 - 808
Mortality:
250 mg/kg bw: 0/2 mortality for males and females
500 mg/kg bw: 1/2 mortalities for males and females
1000 mg/kg bw: 2/2 mortalities for males and females
Clinical signs:
other: 250 mg/kg bw: hypertonia 1/2 male rats 500 mg/kg bw: tremors and spasms in 2/2 male and 2/2 female rats; clonic convulsions, tonic convulsions of upper limbs, hypotonia, piloerection and hypothermia in 1/2 male rats and clonic convulsions, tonic convulsio
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50-value of substance T002102 is 500 (309 - 808) mg/kg bw in male and female rats. The test substance is therefore considered as acute tox category 4 according to CLP classification.