A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Organisation for Economic Co-operation and Development (1981) OECD Short-term and Long-term Toxicology Groups. Final Report; Acute oral Toxicity -
12 May, p. 401

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene

EC Number:

402-990-3

EC Name:

A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene

Cas Number:

163702-01-0

Molecular formula:

C26H32O4

IUPAC Name:

Reaction mass of 2-hydroxy-1-{3-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,1,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one and 2-hydroxy-1-{1-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,3,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one

Test material form:

solid

Remarks:

Form specified in RSS.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Acclimation period: One week
Source: Nossan Correzzana Breeding Centre
Average weight: 200 ± 20g
Quarantine period: 1 week
Diet: Pellets supplied by Nossan, Correzzana, Milan.

Environmental conditions:
Atmospheric pressure
Temperature: 20 ± 2 °C
Humidity: 55 ± 10% relative humidity
Air changes: At least 8 per hour
Light/Dark cycles: 12 hours

Cages:
In transparent polycarbonate model 1290 (dimensions 425 X 260 X h 150 mm) of the company "Tecniplast" Gazzada (Va)

Water:
Ad libitum. Municipal aqueduct water filtered with Seitz filter, chemically and bacteriologically analyzed twice a year.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

1%

Details on oral exposure:

The animals were fasted for the night before treatment, then weighed and the substance administered in a single dose. After this dose, the animals were fasted.

Doses:

5000 mg/kg bw/day

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Observation period: 14 days
Clinical examination - Pathology: Once a day
Signs of toxicity: Weight changes, diarrhea, general condition of the rats and any deviations from the norm.

Rats that survive the observation period are weighed and those weights are then compared to the control animals. Rats that died during this period underwent an autopsy which also examined their organs. Similarly, the rats that survive the observation period were sacrfieced and examined for the prescence of toxicological activity that had not revealed itself through the observation period.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Mortality:

No death was observed in any of the animals treated with 11 samples after one 14-day observation period.

Clinical signs:

other: No alterations attributable to the test substance were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results obtained, we can state that the test substance (EC 402-990-3) given to healthy rats does not cause signs of toxicity due to doses lower than 5000 mg/kg.

Executive summary:

In this guideline study (equivalent to OECD 401), the test substance EC 402-990-3 was shown to have an LD50 of ≥5000 mg/kg.