Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Similar to OECD TG 414 but only 1 dose used

Data source

Reference
Reference Type:
publication
Title:
Short-term test systems to assess thiophosphoryl chloride standards
Author:
Colosi-Esca D, Snca Z, Barbarino F, Surcel D, Papilian VV
Year:
1984
Bibliographic source:
J. Appl. Toxicol. 4, 230-235

Materials and methods

Principles of method if other than guideline:
20 young pregnant female rats were fed with 37.5 mg/kg bw/day thiophosphoryl trichloride diluted in oil/milk vehicle on gd 6-15. A control group was dosed with oil-milk vehicle only. As described by Persaud pregnant animals were sacrificed on gd 20 and fetal mortality rates and fetal weight and length was recorded. Fetuses were examined for external, skeletal and soft tissue abnormalities. Histopathological examination of the soft tissue especially liver and kidney were performed.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further data

Test animals

Species:
rat
Strain:
Wistar
Details on test animals and environmental conditions:
no further data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: oil-milk vehicle
Details on exposure:
20 young pregnant female rats were fed with 37.5 mg/kg bw/day thiophosphoryl trichloride diluted in oil/milk vehicle on gd 6-15. A control group was dosed with oil-milk vehicle only. AS described by Persaud pregnant animals were sacrificed on gd 20 and fetal mortality rates and fetal weight and length was recorded. Fetuses were examined for external, skeletal and soft tissue abnormalities. Histopathological examination of the soft tissue especially liver and kidney were performed.
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
no information given
Duration of treatment / exposure:
Day 6 to 15 of gestation
Frequency of treatment:
Daily
Duration of test:
Up to gd 20
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 37.5 mg/kg bw/day
Basis:

No. of animals per sex per dose:
20
Control animals:
yes, concurrent vehicle
Details on study design:
20 young pregnant female rats were fed with 37.5 mg/kg bw/day thiophosphoryl trichloride diluted in oil/milk vehicle on gd 6-15. A control group was dosed with oil-milk vehicle only. AS described by Persaud pregnant animals were sacrificed on gd 20 and fetal mortality rates and fetal weight and length was recorded. Fetuses were examined for external, skeletal and soft tissue abnormalities. Histopathological examination of the soft tissue especially liver and kidney were performed.

Examinations

Maternal examinations:
no data
Ovaries and uterine content:
no data
Fetal examinations:
Fetal mortality rates and fetal weight and length was recorded. Fetuses were examined for external, skeletal and soft tissue abnormalities. Histopathological examination of the soft tissue especially liver and kidney were performed.
Statistics:
no data
Indices:
not calculated
Historical control data:
no data given

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no data

Details on maternal toxic effects:
no data

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
Compared to concurrent control:
an increased number of apparently normal offspring per gestating rat
an increased fetal median body weight
an increased fetal body weight length

No pathological changes in fetal kidney
In the liver hematopoiesis was more evident compared with the control level, although the toxicological significance of this observation is doubtful.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Increased number of apparently normal offsprings, increased fetal median body weight, increased fetal body length without pathological event.

Applicant's summary and conclusion

Executive summary:

Female Wistar rats received 37.5 mg/kg bw/day thiophosphoryl trichloride in oil-milk vehicle on gd 6 -15 and were sacrificed on gd 20. An increased number of fetuses, increased body weight and length of fetuses were observed without apparent pathological events (tumors or external malformations, Colosi-Esca 1984).