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:

guideline study

Data source

Reference

Reference Type:

study report

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:

The study was conducted according to the test guidelines in effect at the time of study conduct.

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-[1,1-bis(4-hydroxyphenyl)ethyl]phenol

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: individually in 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:

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 a 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

Control animals:

no

Details on study design:

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

Statistics:

No statistical analyses were reported

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths were reported.

Clinical signs:

other: No clinical signs were reported.

Gross pathology:

Gross pathology findings were normal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 >2000 mg/kg

Executive summary:

The test substance was suspended in water and applied to the clipped backs of male and female rats with an occlusive dressing at a dose of 2000 mg/kg of body weight. After 24 hours, the test substance was removed, and the animals were observed for 14 days. There were no deaths or other clinical signs of toxicity during the observation period. The animals gained weight normally. At necropsy, there were no abnormal findings. The acute lethal dermal dose of the test substance was found to be greater than 2000 mg/kg of body weight.