4-(4-isopropoxyphenylsulfonyl)phenol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-04-10 to 1990-05-10

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

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-(4-isopropoxyphenylsulfonyl)phenol

EC Number:

405-520-5

EC Name:

4-(4-isopropoxyphenylsulfonyl)phenol

Cas Number:

95235-30-6

Molecular formula:

C15H16SO4

IUPAC Name:

4-[4-(propan-2-yloxy)benzenesulfonyl]phenol

Details on test material:

- Name of test material (as cited in study report): D - 8
- Molecular formula: C15 H16 O4 S;
- Molecular weight: 292.4;
- Physical state: solid;
- Analytical purity: 99.94 %;
- Purity test date: not stated;
- Lot/batch No.: ME-685;
- Expiration date of the lot/batch: not stated;
- Stability under test conditions: stable at ambient temperature and conditions;
- Storage condition of test material: store in a cool dry place, protected from direct sunlight;

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Limited; Margate, Kent;
- Age at study initiation: approximately 7 to 9 weeks;
- Weight at study initiation: approximately 200 g;
- Fasting period before study: not indicated;
- Housing: individually in grid bottomed polypropylene cages;
- Diet: SQC R and M No. 1 expanded pelleted rodent diet ad libitum; Supplier: Special Diet Services; Witham, Essex;
- Water: mains drinking water from polypropylene bottles ad libitum;
- Acclimation period: eleven days before dosing

ENVIRONMENTAL CONDITIONS
- Temperature: 18 to 21 °C;
- Humidity: 41 - 58 % R.H.;
- Air changes: not stated;
- Photoperiod: 12 hrs dark/12 hrs light;

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Weighed aliquots of the test materials were applied to the clipped skin of the test animals in a dose level of 2000 mg/kg bw. The test material was moistened with water to assure intense contact with the skin of the animals. After spreading of the test material as even as possible on the skin of the test animals, the pplication site was covered with surgical gauze. The trunk of the test animals was then encircled by a length of elastic adhesive bandage to keep the material in contact withthe skin.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males; 5 females

Control animals:

no

Details on study design:

All animals were examined at approximately 30 minutes and 1, 2 and 4 hours after dosing and then daily for fourteen consecutive days. Any signs of toxicity or other effects were noted along with the time of onset and duration. Animals were weighed at weekly intervals.

Statistics:

NA

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Mortality:

No mortalities were observed throughout the study.

Clinical signs:

other: No effects of treatment were observed throughout the study.

Gross pathology:

No significant abnormalities were found at necropsy.

Other findings:

No other findings were observed.

Any other information on results incl. tables

D-8 caused no apparent toxic effect and no mortality following the dermal administration to rats as a single dose of 2000 mg/kg. bw. No effects of treatment were observed throughout the study and no significant abnormalities were found at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

D-8 was tested for acute dermal toxicity in the rat by occlusive application of a single dose of 2000 mg/kg bw. No effects of treatment were observed throughout the study and no significant abnormalities were found at necropsy. It was concluded that the LD50 of the dermal toxicity is greater than 2000 mg/kg bw.

Executive summary:

D-8 was tested for dermal toxicity in five male and five female rats. The test substance was applied in a single dose of 2000 mg/kg bw to the clipped skin of the animals under an occlusive dressing for 24 hours. After removing of the test article, animals were observed fourteen days for signs of treatment. No signs of toxicity were observed throughout the duration of the study. No significant abnormalities were detected at necropsy. The lethal dose on dermal application was determined to be greater than 2000 mg/kg bw.