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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:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

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:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
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-(methylsulfanyl)phenyl]-2-(morpholin-4-yl)propan-1-one

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.5% carboxymethylcellulose 0.1% Tween 80 in distilled water
Details on oral exposure:
Method of administration:gavage
Duration of treatment / exposure:
Test duration: 90 days
Frequency of treatment:
Dosing regime: 5 days/week
No. of animals per sex per dose:
Male: 10 animals at 10 mg/kg bw/day
Male: 10 animals at 25 mg/kg bw/day
Male: 10 animals at 75 mg/kg bw/day
Male: 10 animals at 220 mg/kg bwfday
Female: 10 animals at 10 mg/kg bw/day
Female: 10 animals at 25 mg/kg bwfday
Female: 10 animals at 75 mg/kg bw/day
Female: 10 animals at 220 mg/kg bwfday

Results and discussion

Results of examinations

Details on results:
Clinical observations:
Mortality:
No treatment related mortality occurred.
Signs of systemic toxicity:
In animals treated with 220 mg/kg bw paresis of the hind
limbs and loss of hair was observed. The effects on
locomotor activity became less at the end of the study.
Starting the second week of treatment dim and opaque eyes at
the highest dose level were noted.
Laboratory findings:
Hematology and blood chemistry:
The number of segmented neutrophiles and plateles were
increased in females at 75 mg/kg bw and 220 mg/kg bw.Small
effects on liver-derived enzymes were observed in the highes
dose group.
Effects in organs:
Eye cataract formation and segmental demyelination of
peripheral nerve fibres was noted. In some animals spleen
hemosiderosis was observed.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
75 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
10 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion