9H-Fluoren-9-ol, 9,9'-[1,1'-biphenyl]-4,4'-diylbis-

Endpoint summary

Description of key information

The test substance is of low oral acute toxicity with an oral LD50 (rat) of > 2000 mg/kg bw (LPT, 2014). 

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:

2014-02-11 to 2014-03-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(2001)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(2008)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

(2002)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at start of administration: Approx. 8 weeks
- Weight at start of administration: 160 - 177 g
- Fasting period before study:
- Housing: During the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages (type III plus). Granulated
textured wood was used as bedding material for the cages.
- Diet:Commercial diet, ssniff® R/M-H V1534 (Certificates of analysis provided) ; discontinued approx. 16 hours before administration
- Water: tap water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 12 to 18-fold air change per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light (about 150 lux at approx. 1.50 m room height)




IN-LIFE DATES: From: August 21, 2012; To:September 18, 2012

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
The test item was suspended in sesame oil1 to a concentration of 200 mg/mL. The administration volume was 10 mL/kg b.w., p.o. (resulting in a
dose level of 2000 mg/kg b.w.).



CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A limit test at one dose level of 2000 mg/kg bw was carried out on 6 female animals

Doses:

2000 mg/kg bw (limit test)

No. of animals per sex per dose:

6 female animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours
after administration. All surviving animals were observed for a period of 14 days. Individual body weights were recorded before administration
of the testsubstance and thereafter in weekly intervals up to the end of the study.

- Necropsy of survivors performed: yes (all animals)

- Other examinations performed: changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory,autonomic and central
nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter
each working day. Any tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma were also noted.

Statistics:

No statistical analysis was performed as the method used is not intended to allow a calculation of a precise LD50 value.

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: 24 hrs and 14 days

Mortality:

No death was recorded within the test period.

Clinical signs:

other: No clinical signs were noted.

Gross pathology:

No pathological changes were observed at necropsy.

Other findings:

- Histopathology:
No histopathology was carried out as no macroscopical findings were noted at autopsy.

no further information

Conclusions:

In this acute oral toxicity study in rats (limit test), the LD 50 (females) for the test item was > 2000 mg/kg bw.

Executive summary:

The test item was given to rats by a single oral administration to obtain information on the toxicity, in particular lethality, of the test item. The Acute Toxic Class Method was employed to establish the required information for hazard assessment and hazard classification.

Under the present test conditions, a single oral administration of 2000 mg test item/kg b.w. did not reveal any signs of toxicity. Animals were then observed for 14 days. No death was recorded within the test period. All animals gained the expected weight at the end of the study period. No pathological changes were observed at necropsy. The LD50 value was ranked exceeding 2000 mg/kg b.w.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study is valid without restriction (Klimisch score 1).

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for classification or non-classification

Based on the results of the acute oral study and according to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008 the test item has a low acute toxicity if swallowed (LD₅₀(rat) > 2000 mg/kg bw). Therefore, the test substance must not be classified.