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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 7 August 2009 to 15 October 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate
EC Number:
700-204-6
Cas Number:
1174627-68-9
Molecular formula:
C9H17NO3
IUPAC Name:
methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): DV-SOLV 1059

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (Europe) Laboratories Inc. Toxi Coop Ltd., Budapest
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 218-234 g
- Fasting period before study: overnight until 3 hours after treatment
- Housing: Group caging, 3 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 27 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 11 August 2009 To: 26 August 2009

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3+3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observations at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing then daily for 14 days.
Bodyweight on Day -1, Day 0, Day 7, Day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
No

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
None
Body weight:
No effect
Gross pathology:
No abnormal findings

Any other information on results incl. tables

The median lethal dose of DV-SOLV 1059 after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DV-SOLV 1059 is not classified as hazardous by ingestion according to the criteria of EU DSD or EU GHS
Executive summary:

Two groups, each of three femaleCRL: (W1) BR Wistar rats, were treated with DV-SOLV 1059 by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was administered undiluted at a dosing volume of 1.92 mL/kg.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs and mortality within the first 30 minutes and approximately 1, 2, 3, 4 and 6 hours after treatment on day 1 and once daily during test days 2-15. Body weights were recorded on Day -1, Day 0 (prior to administration) and on days 7 and 14. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The median lethal dose of DV-SOLV 1059 after single oral administration to female rats, observed over a period of 14 days is: LD50(female rat): greater than 2000 mg/kg body weight.

Based on the results of this study, the test substance DV-SOLV 1059 is not classified according to the criteria of Annex VI of Directive 67/548/EECand EU GHS.