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Acute Toxicity: dermal

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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

Constituent 1
Chemical structure
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:
There were no gross signs of toxicity or irritation throughout the observation period;
Body weight:
not specified
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.