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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Key value for chemical safety assessment

Effects on developmental toxicity

Description of key information
A development study (James, 1972) is available which is key study. The data support the hypothesis that administration of the test substance (via intramuscular route of administration) induces abortion and parturition in cows. The data do not indicate an effect on fertility.
Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 3 Feb to 17 June 1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted to an OECD guideline or to GLP. However, the study is well described and documented.
Qualifier:
no guideline followed
Principles of method if other than guideline:
The substance is administered intramuscularly to pregnant cows for 3 consecutive days. The dosing time is set at predetermined stages of gestation. The study looks into effect of administration on the pregnant cow and the timing/viability of pregnancy and offspring.
GLP compliance:
no
Limit test:
no
Species:
other: bovine
Strain:
other: Hereford, Aberdeen Angus and Hereford-Aberdeen Angus
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3 to 7 years of age

No additional data
Route of administration:
intramuscular
Vehicle:
water
Details on exposure:
None stated
Analytical verification of doses or concentrations:
no
Details on mating procedure:
- Proof of pregnancy: confirmation of pregnancy by rectal palpation

No additional data
Duration of treatment / exposure:
Once per day 3 days starting on Days 185, 215, 245 and 268 of gestation
Frequency of treatment:
Once per day
Duration of test:
None stated
Remarks:
Doses / Concentrations:
5 mg/day
Basis:
nominal conc.
No. of animals per sex per dose:
16 females
Control animals:
yes, concurrent vehicle
Details on study design:
None stated
Maternal examinations:
The uterus of each cow was palpated per rectum prior to initiation of each series of injections and on day 7 after the start of each series of injections. Observations of cows for calving were made at least once a day and usually 2 to 3 times each day.
Ovaries and uterine content:
None stated
Fetal examinations:
After calving, cows were observed for signs of retained placenta and metritis.
Statistics:
Squares analysis in combination with a Dunnett's t test.
Indices:
None stated
Historical control data:
None stated
Details on maternal toxic effects:
Maternal toxic effects:no effects

Details on maternal toxic effects:
Gestation length was shortened significantly by the test substance when injections were started on day 268 of gestation. Variation in interval between injection and calving was reduced by the test substance. Maximum gestation length for cows treated with the test substance (273 days) was less than minimum gestation length (275 days) for cows treated with water.
Dose descriptor:
NOAEL
Based on:
test mat.
Basis for effect level:
other: developmental toxicity
Remarks on result:
not determinable
Remarks:
no NOAEL identified
Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes

Details on embryotoxic / teratogenic effects:
Retained placenta was observed in all cows treated with the test substance. Use of the corticoid at day 268 of gestation did not affect calf viability, also did not affect the mean intervals between calving to pregnancy and percentage of cows pregnant. All calves aborted by cows treated with the test substance at Day 215 of gestation died.
Abnormalities:
not specified
Developmental effects observed:
not specified
Conclusions:
The data support the hypothesis that administration of the test substance (via intramuscular route of administration) induces abortion and parturition in cows. The data do not indicate an effect on fertility.
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
adverse effect observed
Study duration:
subchronic
Species:
other: bovine
Quality of whole database:
2 (reliable with restrictions)
Additional information

A development study (James, 1972) is available which is key study. The data support the hypothesis that administration of the test substance (via intramuscular route of administration) induces abortion and parturition in cows. The data do not indicate an effect on fertility.


Justification for selection of Effect on developmental toxicity: via dermal route:
The study was not conducted to an OECD guideline or to GLP. However, the study is well described and documented.

Justification for classification or non-classification

Based on the avaliable data, the substance was classfied as Repr. 1B in according to Regulation (EC) No. 1272/2008 Tables 3.7.1.

Additional information