Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study

Data source

Reference
Reference Type:
publication
Title:
Evaluation of effects of prenatal exposure to the cyanide and thiocyanate in wistar rats
Author:
Altamir Benedito de Sousa, Paulo César Maiorka, Ivair Donizete Goncalves, Lílian Rose Marques de Sá, Silvana Lima Górniak
Year:
2007
Bibliographic source:
AB de Sousa, PC Maiorka, ID Goncalves, LRM de Sá, SL Górniak, Evaluation of effects of prenatal exposure to the cyanide and thiocyanate in wistar rats, Reproductive Toxicology 23 (2007) 568–577

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.31 (Prenatal Developmental Toxicity Study)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Duration of treatment / exposure:
GD6 - GD20
Control animals:
yes, plain diet

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes

Details on maternal toxic effects:
Increase in the number of reabsorption vacuoles in follicular colloid

Effect levels (maternal animals)

Dose descriptor:
LOAEL
Effect level:
30 mg/kg bw/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Both diet intake and body weight gain of dams were similar in all groups throughout trial. The reproductive data show that CN or SCN in drinking water did not cause any change in the number of corpora lutea, preimplantation loss, postimplantation loss, fetal and placental weight or fetal length. There were no dams with total litter resorptions.
Executive summary:

Both diet intake and body weight gain of dams were similar in all groups throughout trial. The reproductive data show that CN or SCN in drinking water did not cause any change in the number of corpora lutea, preimplantation loss, postimplantation loss, fetal and placental weight or fetal length. There were no dams with total litter resorptions. No significant alterations were found in the skeletal variations between control and experimental groups. Nevertheless, a higher incidence (p < 0.05) in the number of fetuses with visceral alteration was observed, but not in the number of litters affected from dams that received the largest dose of KCN 30 mg/kg/day. Serum levels of glucose were significantly higher (p< 0.05)

in dams from the KCN – 30 mg/kg/day group. The body weight gain of the offspring was similar in all groups. The microscopic changes were dose and time related, thus the lesions were more conspicuous in dams given 30 mg/kg/day of KCN and in dams with 24 mg/kg/day of KSCN. There were no histological alterations in the lung and spleen. Pups also showed the same lesions in liver and brain as described for their mothers; however, the lesions were milder.