Registration Dossier

Administrative data

Endpoint:
one-generation reproductive toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Teratogenic study of ethylene and propylene oxide and n-Butyl Acetate. Cincinnati (OH)
Author:
Hackett PL, Brown MG, Buschbom RL, Clark ML, Miller RA, Music RL, Rowe SE, Schirmer RE, Sikov MR
Year:
1982
Bibliographic source:
Department of Health and Human Services (US), Centers for Disease Control & Prevention; NIOSH (National Institute for Occupational Safety and Health)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 415 (One-Generation Reproduction Toxicity Study)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
inhalation
Duration of treatment / exposure:
7 hours/day, 5 days/week for 3 weeks prior to gestation and 7 hours/day from 3 weeks
Details on study schedule:
7 hours/day, 5 days/week for 3 weeks prior to gestation and 7 hours/day from 3 weeks before mating to day 16 of pregnancy based on reduced corpora lutea, implantations and surviving live fetuses. These effects occurred in the presence of maternal toxicity

Results and discussion

Results: P0 (first parental animals)

Reproductive function / performance (P0)

Reproductive performance:
effects observed, treatment-related
Description (incidence and severity):
reduced corpora lutea, implantations and surviving live fetuses

Details on results (P0)

reduced corpora lutea, implantations and surviving live fetuses

Effect levels (P0)

Dose descriptor:
LOEC
Effect level:
1 188 mg/m³ air (nominal)
Based on:
test mat.
Sex:
female

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion