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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
screening for reproductive / developmental toxicity
Type of information:
other: read across based on OECD Toolbox v3.4
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Justification for type of information:
See attached OECD Toolbox v3.4 study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
Version / remarks:
Read Across was from OECD TG 415, 416, 421 and 422
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:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
other: oral gavage and oral feed

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Effect level:
724 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: various

Results: F1 generation

Effect levels (F1)

Remarks on result:
not measured/tested

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion