PROCESS OIL

Toxicity to reproduction

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

Study period:

July 2012 to March 2013

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

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)

Remarks:

certificate nr 2011/40 on July 19th 2011

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

PROCESS OIL

IUPAC Name:

PROCESS OIL

Test material form:

gas under pressure: refrigerated liquefied gas

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on mating procedure:

Females were paired with males from the same dose--level group. One female was placed with one male, in the latter's cage, during the night. Sibling pairings were avoided.
Confirmation of mating was made in the morning by checking for the presence of a vaginal plug or for sperm in a vaginal lavage.
There were no treatment-related effects on mating and fertility data. All animals mated within comparable mean number of days. All females were pregnant, except one in each of the 0, 100, and 300 mg/kg/day groups

Duration of treatment / exposure:

For males: - 5 weeks
For females: - 2 weeks before paring, during mating and pregnancy, until day 5 post-partum.

Frequency of treatment:

Daily

Details on study schedule:

The chronology of the study is summarized as follows:

Procedure Calendar Date
Study plan approved by
. Study Director 23 October 2012
. Sponsor Representative 05 November 2012

Experimental starting date
(day of arrival of the animals) 25 October 2012
. Identification, weighing and randomization 26 October 2012

First day of treatment 31 October 2012

Mating (day 0 p.c.)
. first females 15 November 2012
. last females 18 November 2012

Functional Observation Battery and motor activity
. males 05 December 2012
. females 11 to 13 December 2012

Hematology and blood biochemistry
. males 06 December 2012
. females 12 to 14 December 2012

Delivery (day 0 p.p.)
. first females 06 December 2012
. last females 09 December 2012

Necropsy date of males 06 December 2012

Necropsy date of females (day 6 p.p.)
. first females 12 December 2012
. last females 15 December 2012

Experimental completion date 11 February 2013

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0 mg/kg/day 0 mg/mL
Basis:
nominal in water

Doses / concentrations 2

Remarks:

Doses / Concentrations:
100 mg/kg/day 20 mg/mL
Basis:
nominal in water

Doses / concentrations 3

Remarks:

Doses / Concentrations:
300 mg/kg/day 60 mg/mL
Basis:

Doses / concentrations 4

Remarks:

Doses / Concentrations:
1000 mg/kg/day 200 mg/mL
Basis:

No. of animals per sex per dose:

10

Control animals:

yes

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:

NOEL

Effect level:

1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Overall reproductive toxicity

Reproductive effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Based on the experimental conditions of the study:
- The No Observed Effect Level (NOEL) for reproductive performance was considered to be 1000 mg/kg/day in the absence of any treatment-related effect on mating and fertility at this dose-level.