Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study. Available as unpublished report. No restrictions, fully adequate for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994
Reference Type:
other: Amendment to the report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
yes
Remarks:
, modified according to the acute toxic class method
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
162691-58-9
EC Number:
605-300-0
Cas Number:
162691-58-9
IUPAC Name:
162691-58-9
Details on test material:
- Name of the test substance used in the study report: Asta-C9-Acetal
- Physical state/appearance: liquid, yellowish
- Storage conditions: refrigerator, exclusion of light

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: DR . K . Thomae Gmbh, Biberach, Frg
- Age at study initiation: Young adult animals
- Weight at study initiation: animals of comparable weight: (150g - 300g)
- Fasting period before study: at least 16 hours (water was available ad libitum)
- Housing: One animal per cage (type: stainless steel wire mesh cages, DK-III)
- animal identification: cage cards and group identification by tail marking.
- Diet: Kliba-labordiaet 343, Klingentalmuehle AG Kaiseraugst, Switzerland, ad libitum
- Water: tap water ad libitum.
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): fully airconditioned rooms
- Photoperiod: 12 h light and 12 h dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Remarks:
DAB 10
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40 g/100 mL
- Amount of vehicle: 5 mL/kg
- Justification for choice of vehicle: The test substance is insoluble in water.
Doses:
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Observation period: 14 days
- Individual body weights were determined shortly before administration (day 0), weekly thereafter and at the end of the study (before fasting period).
- Recording of signs and symptoms several times on the day of administration (at least each working day for the individual animals). A check for general observations and mortality was made twice each working day and once on weekends and on public holidays.
- Necropsy at the last day of observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy with gross-pathological examination. Necropsy of all animals that die before as soon as possible.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: Male animals: impaired general state (1/3), poor general state (3/3), dyspnea (3/3), apathy (3/3), staggering (3/3), piloerection (3/3). All effects were absent within one day. Female animals: impaired general state (1/3), dyspnea (1/3), piloerection (1/3
Gross pathology:
no pathologic findings noted

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Under the conditions of the performed test the LD50 was determined to be greater than 2000 mg/kg bw.
Executive summary:

In a GLP compliant acute toxicity study performed according to EU method B.1 threeWistar rats per sex were exposed to 2000 mg/kg bw of the test substance dissolved in olive oil via oral gavage. After an observation period of 14 days the surviving animals were necropsied. Impaired general state, dyspnea, piloerection, and orange-coloured urine were observed, but animals appeared normal 4 days after application. No mortality occured and no abnormalities were detected in sacrificed animals. The LD50 was determined to be greater than 2000 mg/kg bw.