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

Endpoint summary

Description of key information

In an acute oral toxicity study in rat (EU method B.1, GLP) the LD50 was greater than 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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 Available as unpublished report.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

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

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

In a GLP compliant acute toxicity study performed according to EU method B.1 three Wistar rats per sex were exposed to 2000 mg/kg bw of the test substance dissolved in olive oil via oral gavage (BASF 1994). 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.

Justification for selection of acute toxicity – oral endpoint
One acute oral toxicity study is available. This study is adequate for covering this endpoint

Justification for classification or non-classification

Based on oral LD50 in rats of greater than 2000 mg/kg bw, classification for acute oral toxicity of the test substance is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.