Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test type (migrated information)
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:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EC Annex V,B.7
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-(1,4-phenylene)bis((4H-3,1-benzoxazine-4-one)
EC Number:
418-280-1
EC Name:
2,2-(1,4-phenylene)bis((4H-3,1-benzoxazine-4-one)
Cas Number:
18600-59-4
Molecular formula:
C22H12N2O4
IUPAC Name:
2-[4-(4-oxo-4H-3,1-benzoxazin-2-yl)phenyl]-4H-3,1-benzoxazin-4-one

Test animals

Species:
other: Sprague-Dawley (Crl: CD VAF)
Strain:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: methylcellulose
Details on exposure:
Method of administration or exposure: 7 days a week by gavage from start to euthanasia.
Analytical verification of doses or concentrations:
not specified
Frequency of treatment:
Dosing regime (males): 7days/week
Dosing regime (females): 7days/week
No. of animals per sex per dose:
Male: 30 animals at 0 mg/kg or mg/l
Male: 30 animals at 10 mg/kg or mg/l
Male: 30 animals at 150 mg/kg or mg/l
Male: 30 animals at 1000 mg/kg or mg/l
Female: 30 animals at 0 mg/kg or mg/l
Female: 30 animals at 10 mg/kg or mg/l
Female: 30 animals at 150 mg/kg or mg/l
Female: 30 animals at 1000 mg/kg or mg/l

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

No treatment related findings.

dose nr. of life pups/litter (day 0)

0 15.3
10 16.5
150 15.7
1000 15.8

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day
Sex:
male/female
Basis for effect level:
reproductive performance

Results: F1 generation

Details on results (F1)

Effect on F1 generation:
No treatment related findings.

dose F1 sex ratio viability index

0 51.9 96.9%
10 50.3 98.1%
150 52.8 97.6%
1500 49.1 96.2%

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
1 500 mg/kg bw/day
Sex:
male/female
Basis for effect level:
viability
other: sex ratio

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion