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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2018

Materials and methods

Test guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
6-dimethylamino-3,3-bis(4-dimethylaminophenyl)phthalide
EC Number:
216-293-5
EC Name:
6-dimethylamino-3,3-bis(4-dimethylaminophenyl)phthalide
Cas Number:
1552-42-7
Molecular formula:
C26H29N3O2
IUPAC Name:
6-dimethylamino-3,3-bis(4-dimethylaminophenyl)phthalide
impurity 1
Reference substance name:
dihydrogen oxide
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
dihydrogen oxide
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Duration of treatment / exposure:
28 days
Control animals:
not specified

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related

Effect levels

Key result
Dose descriptor:
NOEL
Effect level:
40 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
clinical signs

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion