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Toxicological information

Toxicity to reproduction

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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