Reaction mass of lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate and lithium sodium hydrogen 4-amino-6-({5-[(5-chloro-2,6-difluoropyrimidin-4-yl)amino]-2-sulfonatophenyl}diazenyl)-5-hydroxy-3-{[4-(vinylsulfonyl)phenyl]diazenyl}naphthalene-2,7-disulfonate

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

other: Information from migrated NONS file, as per inquiry number 06-2120053365-59- 0000, permission to refer granted by ECHA

Title:

Unnamed

Year:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.31 (Prenatal Developmental Toxicity Study)

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

EC number 401-560-2
Notification number 87-04-0062-02
Result Partly provided (some studies submitted less than 12 years previously)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: Deionized water

Details on exposure:

Method of administration or exposure: stomach tube

Frequency of treatment:

Dosing regime: 7 days/week

No. of animals per sex per dose:

Number of dams and doses
23 at 0 mg/kg or mg/l
23 at 62.5 mg/kg or mg/l
23 at 250 mg/kg or mg/l
23 at 1000 mg/kg or mg/l

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Details on maternal toxic effects:
Slightly decreased mean body weight of all pregnant high
dose females; mean body weight and body weight gains were
not influenced by the administration of the test substance
in mid and low dose groups. A transient reduction in
absolute food consumption was noted for high dose dams only
durch the initial treatment period. Absolute/relative food
consumption was not influenced by the administration of the
test substance in mid and low dose groups.
Neither deaths nor substance related clinical signs of
intoxination occured throughout the study. All high dose
dams exhibited discolored feces.
No related adverse findings were observed at necropsy in all
dose groups.
No dams with either abortions, premature delivery or
females at termi with intrauterine deaths only, et any

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

250 mg/kg bw/day (nominal)

Basis for effect level:

other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Details on embryotoxic / teratogenic effects:
Effects on fetus - Gross:
No substance related toxic effects.
Effects on fetus - Soft tissue:
No substance related toxic effects.
Effects on fetus - Skeletal:
No toxic substance related toxic effects.

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

250 mg/kg bw/day (nominal)

Basis for effect level:

other: embryotoxicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified