4,4',4''-(ethan-1,1,1-triyl)triphenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in accordance with relevant guideline; the study was selected as a key study because the information provided is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference

Reference Type:

other: reference to body responsible for the test

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Remarks:

Study was completed according to the test guidelines at the time of completion.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4',4''-(ethan-1,1,1-triyl)triphenol

EC Number:

405-800-7

EC Name:

4,4',4''-(ethan-1,1,1-triyl)triphenol

Cas Number:

27955-94-8

Molecular formula:

C20H18O3

IUPAC Name:

4,4',4''-(ethan-1,1,1-triyl)triphenol

Details on test material:

- Purity: 99%

Test animals

Species:

rat

Strain:

other: Crl:CD® (SD) BR VAF plus

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 7-10 weeks
- Weight at study initiation: 200-252 g
- Fasting period before study: Not reported.
- Housing: Individual metal cages with wire mesh floors.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): mean value 47%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: other: Distilled water

Details on dermal exposure:

TEST SITE
- Area of exposure: 50x50 mm
- % coverage: 10% of total body surface
- Type of wrap if used: Gauze held in place with an impermeable dressing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with warm water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg of body weight.
- Concentration (if solution): 71.4% v/v in distilled water; paste, not solution.
- Constant volume or concentration used: Yes; constant volume of 2.80 mL/kg
- For solids, paste formed: Yes.

Duration of exposure:

24 hours.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 /sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations: After test substance administration, at frequent intervals for Day 1. Twice daily thereafter.
- Frequency of weighing: Days 1 (day of dosing), 8, and 15.
- Necropsy of survivors performed: Yes.

Statistics:

Not reported.

Results and discussion

Effect levels

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:

Signs of toxcity related to dose levels:
No signs of systemic toxicity were observed.

Body weight:

Test organisms achieved the anticipated body weight gains throughout the study.

Gross pathology:

No treatment-related macroscopic findings were observed.

Other findings:

There were no signs of skin irritation or observable signs of toxicity (local).

Any other information on results incl. tables

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

Applicant's summary and conclusion

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability). No specimen deaths were recorded. LD50 >2000 mg/kg.

Executive summary:

The test substance suspended in water was applied with an occlusive dressing to the clipped backs of male/female rats at a dose of 2000 mg/kg of body weight. The test substance was removed after 24 hours, with observation for 14 days. There were no deaths or other clinical signs during the observation period. Gross necropsy findings were normal. The acute dermal LD50 was greater than 2000 mg/kg.