Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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

Constituent 1
Chemical structure
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.