Reaction mass of (2R,7aR)-2,4,6,6-Tetramethyl-7,7a-dihydro-1,3-benzodioxol-5(6H)-one and (2S,7aS)-2,4,6,6-Tetramethyl-7,7a-dihydro-1,3-benzodioxol-5(6H)-one

Acute Toxicity: oral

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 Available as unpublished report.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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Reference 2

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

Test material information

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.