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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-propylphthalimide
EC Number:
226-189-1
EC Name:
N-propylphthalimide
Cas Number:
5323-50-2
Molecular formula:
C11H11NO2
IUPAC Name:
2-propyl-1H-isoindole-1,3(2H)-dione
Constituent 2
Chemical structure
Reference substance name:
N-sec-butylphthalimide
EC Number:
233-295-1
EC Name:
N-sec-butylphthalimide
Cas Number:
10108-61-9
Molecular formula:
C12H13NO2
IUPAC Name:
2-sec-butyl-1H-isoindole-1,3(2H)-dione
Constituent 3
Chemical structure
Reference substance name:
N-butylphthalimide
EC Number:
216-157-5
EC Name:
N-butylphthalimide
Cas Number:
1515-72-6
Molecular formula:
C12H13NO2
IUPAC Name:
2-butyl-1H-isoindole-1,3(2H)-dione
impurity 1
Reference substance name:
Unknown impurities.
Molecular formula:
Not available as unknown impurities.
IUPAC Name:
Unknown impurities.
1
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
water
Test material form:
liquid
Details on test material:
Batch CNAA053604
Color: clear yellowish
Form: liquid
Storage conditions: Room temperature in a closed container, protected from light.

Administration / exposure

Route of administration:
oral: gavage
Doses / concentrationsopen allclose all
Dose / conc.:
50 mg/kg bw/day (actual dose received)
Dose / conc.:
100 mg/kg bw/day (actual dose received)
Dose / conc.:
300 mg/kg bw/day (actual dose received)

Results and discussion

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
> 0 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
mortality
Remarks on result:
other: preliminary results, study in progress

Target system / organ toxicity

Key result
Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Under the conditions of the present study, Reaction mass of N-butylphthalimide and n-propylphthalimide and N-sec-butylphthalimide administered at 50, 100 or 300 mg/kg bw/day by oral gavage did not cause signs of systemic toxicity and did not adversely influence the reproductive performance (gonad function, mating behavior, conception, parturition) in parental male and female Hsd.Han: Wistar rats.
Executive summary:

Under the conditions of the present study, Reaction mass of N-butylphthalimide and n-propylphthalimide and N-sec-butylphthalimide administered at 50, 100 or 300 mg/kg bw/day by oral gavage did not cause signs of systemic toxicity and did not adversely influence the reproductive performance (gonad function, mating behavior, conception, parturition) in parental male and female Hsd.Han: Wistar rats.

The development of the F1 offspring was not impaired from birth to post-natal day 13 at any dose level after repeated oral administration of dams.

Based on these observations the No Observed Adverse Effect Levels (NOAEL) were determined as follows:

NOAEL for systemic toxicity of male/female rats: 300 mg/kg bw/day

NOAEL for reproductive performance of male/ female rats: 300 mg/kg bw/day

NOAEL for F1 Offspring: 300 mg/kg bw/day