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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Results of an study conducted in accordance with generally accepted scientific principles. Possible deficiencies in the reporting of the endopoint do not affect the quality of relevant results.

Data source

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

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)
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4-diethylbenzene
EC Number:
203-265-2
EC Name:
1,4-diethylbenzene
Cas Number:
105-05-5
Molecular formula:
C10H14
IUPAC Name:
1,4-diethylbenzene
Details on test material:
Commercial, purity 97.2%

Test animals

Species:
rat
Strain:
other: slc:SD
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Duration of treatment / exposure:
Male: 44 days including 14 days before mating.
Female: from 14 days before mating to day 3 of lactation.
Premating exposure period: male, 14 days; female, 14 days
Frequency of treatment:
7 days/week
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0 mg/kg
Basis:
no data
Remarks:
Doses / Concentrations:
30 mg/kg
Basis:
no data
Remarks:
Doses / Concentrations:
150 mg/kg
Basis:
no data
Remarks:
Doses / Concentrations:
750 mg/kg
Basis:
no data
No. of animals per sex per dose:
12 animals/sex/group
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
no effects observed

Details on results (P0)

The results observed in mating, fertility and estrous cycle did not reveal any effects attributable to the administration of test substance.
Observation of delivery, all gestation animals delivered of pups normally, and there were not a treatment-related effect throughout the lactation period.

Effect levels (P0)

Dose descriptor:
NOEL
Effect level:
750 mg/kg bw/day
Based on:
not specified
Sex:
male/female

Results: F1 generation

General toxicity (F1)

Mortality / viability:
no mortality observed
Description (incidence and severity):
The external examination of pups revealed no effects attributable to the administration of test substance.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
The body weights of fetuses showed the favorably growths until Day 4 of lactation.

Details on results (F1)

The necropsy of stillborn, dead pups until day 4 of lactation and newborns at day 4 of lactation did not reveal any effects attributable to the administration of test substance.

Effect levels (F1)

Dose descriptor:
NOEL
Generation:
F1
Effect level:
750 mg/kg bw/day
Based on:
not specified
Sex:
male/female

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The influences of test substance on reproductive and developmental toxicity were not observed in both male and female rats receiving 750 mg/kg/day, therefore maximum NOELs were considered to be 750 mg/kg/day in both sexes.