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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 2008 - April 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study according to OECD423 (dated 17 December 2001)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
dated 17 December 2001
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
dated August 1998
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: "Methylpentanal Roh"

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld.
- Age at study initiation: Approximately 8 weeks at the time of the test substance administration.
- Weight at study initiation: 180 - 197 g
- Fasting period before administration: yes (the evening before adminstration until 3 hrs afterwards)
- Housing: Single caging in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week
- Diet: Ssniff R/M-H maintenance diet for rats and mice (item V1534-3 ), ad libitum
- Water: Tap water from an automatic watering system, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 22.5 °C (continuous control and recording).
- Humidity (%): Average of 49.39 % (continuous control and recording).
- Air changes (per hr): 12 per hour.
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.

IN-LIFE DATES: From: To: 2008-02-19 to 2008-03-05

Administration / exposure

Route of administration:
oral: gavage
Doses:
2000 mg of the test substance per kg body weight
No. of animals per sex per dose:
2 x 3 female animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before administration, 7 days p.a., 14 days p.a.
- Necropsy of survivors performed: yes
- Other examinations performed: Observations were performed 0.5, 1, 2, 3, 4 and 6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
All animals survived until the scheduled termination of the study.
Clinical signs:
No abnormalities were observed during the study period.
Body weight:
All animals gained weight in both weeks p.a.
Gross pathology:
No animal showed any abnormal finding at the necropsy 14 days p.a.

Applicant's summary and conclusion