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

Endpoint summary

Description of key information

Study conducted to recognised testing guidelines with GLP certification.

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

Study period:

1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

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

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.

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

1

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

1

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

not specified

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

olive oil

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: None

Gross pathology:

Effects on organs: No abnormability was noted during the necroscopy of all the animals

Other findings:

Signs of toxicity (local): None
No mortality during the observation period (15 days)

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

1

Additional information

Oral LD50 >= 5000 mg/kg bw

Dermal LD50 >2000 mg/kg bw

Justification for classification or non-classification

The substance does not meet the criteria for classification in accordance with the classification, labelling and packaging regulation (EC 1272/2008).