Sulisobenzone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from publication.

Data source

Reference

Reference Type:

publication

Title:

Final Report on the Safety Assessment - Test material

Author:

COSMETIC INGREDIENT REVIEW

Year:

1983

Bibliographic source:

Journal of the American College of Toxicology

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute dermal toxicity study was conducted by using the given test chemical in rodent.

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sulisobenzone

EC Number:

223-772-2

EC Name:

Sulisobenzone

Cas Number:

4065-45-6

Molecular formula:

C14H12O6S

IUPAC Name:

5-benzoyl-4-hydroxy-2-methoxybenzenesulfonic acid

Test material form:

solid

Details on test material:

- Name of test material: Benzenesulfonic acid, 5-benzoyl-4-hydroxy-2-methoxy-
- Molecular formula: C14-H12-O6-S
- Molecular weight: 308.3088 g/mol
- Smiles notation: c1(cc(c(cc1O)OC)S(=O)(=O)O)C(=O)c1ccccc1
- InChl: 1S/C14H12O6S/c1-20-12-8-11(15)10(7-13(12)21(17,18)19)14(16)9-5-3-2-4-6-9/h2-8,15H,1H3,(H,17,18,19)
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

rabbit

Strain:

other: albino

Sex:

not specified

Administration / exposure

Type of coverage:

other: Dermal

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: The test substance was applied to the epilated skin of the back or flanks
REMOVAL OF TEST SUBSTANCE
- Washing (if done): it was then washed off.
- Time after start of exposure: 18-24 hours

Duration of exposure:

18-24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

Total = 10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were made daily for signs of toxicity and irritation.
- Necropsy of survivors performed: yes, animals were autopsied following the 5- to 7-day observation period.

Statistics:

not specified

Results and discussion

Preliminary study:

not specified

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at 5000 mg/kg bw.

Clinical signs:

other: There were no gross signs of toxicity or irritation throughout the observation period;

Gross pathology:

Autopsy revealed one animal with congested kidneys.

Other findings:

not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

Acute dermal toxicity dose (LD50) value was considered to be >5000 mg/kg bw, when 10 albino rabbits were treated with the given test chemical via dermal route.

Executive summary:

The acute dermal toxicity study was conducted by using the given test chemical in 10 albino rabbits at the dose concentration of 5000 mg/kg bw. The test substance was applied to the epilated skin of the back or flanks and held in contact for 18-24 hours; it was then washed off. Observations were made daily for signs of toxicity and irritation. Animals were autopsied following the 5- to 7-day observation period. No mortality was observed at 5000 mg/kg bw. There were no gross signs of toxicity or irritation throughout the observation period. Autopsy revealed one animal with congested kidneys.

Hence, the LD50 value was considered to be >5000 mg/kg bw, when 10 albino rabbits were treated with the given test chemical via dermal route.