Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
developmental toxicity
Type of information:
(Q)SAR
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6

Data source

Reference
Reference Type:
grey literature
Title:
No information
Bibliographic source:
Data from FDA-TERIS program

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2,3,6-tetrahydrophthalimide
EC Number:
201-602-8
EC Name:
1,2,3,6-tetrahydrophthalimide
Cas Number:
85-40-5
Molecular formula:
C8H9NO2
IUPAC Name:
2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3-dione

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Development - teratogenicity negative   Multicase model A49

Trainig set:n=323, Validation : LGO (10%) gave: Sens.=60-100%, Spec.=75-92.9%, Conc.=70-88.9% Domain : 0.43

Applicant's summary and conclusion