Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD TG 407 including examination of reproductive organs
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD TG 407
Deviations:
not applicable
Principles of method if other than guideline:
Type: other: subacute study : examination of reproductive organs
GLP compliance:
yes
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: 1,2-dichloro-4-nitrobenzene, purity: 99 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: migrated dataset
Duration of treatment / exposure:
28 d
Frequency of treatment:
daily
Duration of test:
migrated dataset
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 4, 20, 100 mg/kg bw/day in sesame oil
Basis:

No. of animals per sex per dose:
migrated dataset
Control animals:
yes, concurrent vehicle
Details on study design:
Duration of test: 28 d

Results and discussion

Observed effects

see freetext RS

Any other information on results incl. tables

RS-Freetext:
OBSERVATIONS:
No death occurred throughout the study
unspecific signs of intoxication: 100 mg-group, m/f: irregular respiration, stilted gain, >= 20 mg/kg bw/day, m/f: increased salivation;
all groups: body weight gain was not impaired, food consumption unaffected, >=20 mg/kg bw/day(m/f): slightly increased water intake (not significant, not dose dependant)
REPRODUCTIVE ORGAN EVALUATION:
no pathologic findings were reported.

Applicant's summary and conclusion

Executive summary:

During 28-day-treatment of male and female Wistar rats with 0, 4, 20 or 100 mg/kg bw/d 1,2 -dichloro-4 -nitrobenzene dissolved in sesame oil according to OECD TG 407 reproductive organs were not affected (Hoechst AG 1993).