Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
other information
Study period:
05 July 2007 - 21 January 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD test guidelines, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
Deviations:
no
GLP compliance:
yes
Remarks:
The study report includes a statement of GLP compliance signed by the Study Director, and a statement of Quality Assurance, however no GLP certificate issued by an independant body (such as a National Competent Authority or GLP monitoring authority) was i
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-methoxy-3-methylbutyl acetate (MMB-Ac)
- Physical state: Colourless liquid with ester-like odour.
- Analytical purity: 99.4%
- Impurities (identity and concentrations):3-methoxy-3-methylbutan-1-ol, 0.4%
3-methoxy-1-(methoxymethoxy)-3-methylbutane, 0.2%
- Lot/batch No.: 183227
- Stability under test conditions: Stable for over one year from manufacture when stored at room temperature.
- Storage condition of test material: Room temperature.
- Other:

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

open allclose all
Dose descriptor:
NOEL
Remarks:
Repeated dose toxicity
Effect level:
150 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Decreases were noted in RBC in males and females dosed at the highest dose level (1000 mg/kg bodyweight); decreases in hemoglibin and hematocrit values were noted in females in the 1000 mg/kg group also. No adverse effects seen at 150 mg/kg.
Dose descriptor:
NOEL
Remarks:
Reproductive effects
Effect level:
1 000 mg/kg bw/day
Based on:
test mat.
Sex:
male/female

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The NOEL and NOAEL for repeated dose toxicity for the test substance in rats were determined to be 150 mg/kg/day for both sexes.
No treatment-related effects on reproduction were seen, so the NOEL for reproductive effects was determined to be 1000 mg/kg/day.