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Diss Factsheets

Administrative data

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.

Data source

Reference
Reference Type:
publication
Title:
Effect of corticoid administration on bovine pregnancy
Author:
James W. Lauderdale, Ph.D.
Year:
1972
Bibliographic source:
Journal of American Veterinary Medical Association V.160,No. 6
Report date:
1972

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Flumetasone
EC Number:
218-370-9
EC Name:
Flumetasone
Cas Number:
2135-17-3
Molecular formula:
C22H28F2O5
IUPAC Name:
(1R,2R,3aS,3bS,5S,9aS,9bR,10S,11aS)-5,9b-difluoro-1,10-dihydroxy-1-(2-hydroxyacetyl)-2,9a,11a-trimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch No.: Not specified
Purity: Not specified

Test animals

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

Administration / exposure

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
Doses / concentrations
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

Examinations

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

Results and discussion

Results: maternal animals

Maternal developmental toxicity

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.

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Based on:
test mat.
Basis for effect level:
other: developmental toxicity
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Results (fetuses)

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.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

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.