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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test compliant with GLP and Guideline OECD 414(2001) and OECD 415 (1983)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Combined one generation and prenatal developmental toxicity study in rat", OECD 414 (2001) and 415 (1983)
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one
EC Number:
400-600-6
EC Name:
2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one
Cas Number:
71868-10-5
Molecular formula:
C15H21NO2S
IUPAC Name:
2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.5% aqueous carboxymethylcellulose
Details on exposure:
Method of adminstration or exposure: gavage
Frequency of treatment:
Dosing regime (males): 7 days/week
Dosing regime (females): 7 days/week
Details on study schedule:
Number of litters per dose/conc.: 24 at mg/kg or mg/l
No. of animals per sex per dose:
Male: 24 animals at 40 mg/kg or mg/l
Male: 24 animals at 80 mg/kg or mg/l
Male: 24 animals at 120 mg/kg or mg/l
Female: 48 animals at 40 mg/kg or mg/l
Female: 48 animals at 80 mg/kg or mg/l
Female: 48 animals at 120 mg/kg or mg/l

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

Statistically significant decreases in body weight were observed in the high dose males on Day 22 and from Day 36 to Day 99 of the study. A statistically significant decrease in body weight gain was observed in the mid-dose males on Day 43 of the study.
A reduction in body weight gain was noted in all group females allowed to give birth on gestation Day 9. This reduction was statistically significant for the mid-dose group.
Fertility index was, in general, decreased in all treated females with particular emphasis in the high dose group.

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
40 mg/kg bw/day
Sex:
male/female

Results: F1 generation

Details on results (F1)

Effects on F1 generation:
Stillbirths or total litter loss were noted the day of parturition or the day after parturition in all high dose females which gave birth. Statistically significant increases in pup loss on Day 1 post-partum, cumulative loss on Days 4 and 14 post-partum were observed in the mid-dose group.
In addition, litter weight was statistically significantly decreased in the mid-dose group on Days 1, 4 and 14 post-partum. Litter size and mean pup weight were also statistically significantly decreased in the mid-dose group on Day 14 post-partum. The survival of pups was drastically decreased in the mid-and high dose groups.
Pre-weaning clinical signs showed marked mortality of the pups in the high dose group.
Statistically significant decreases in terminal body weight were observed in the high dose males and in the high dose females.
Lateral ventricles of the brain enlarged, head with domed shape limbs short or malrotated, cleft palate, anasarca and alteration on the tail were present at necropsy of the decedent pups or pups at weaning.

Effect levels (F1)

Dose descriptor:
LOAEL
Generation:
F1
Effect level:
40 mg/kg bw/day
Sex:
male/female

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion