Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
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 peer reviewed journal .

Data source

Reference
Reference Type:
review article or handbook
Title:
Final Report on the Safety Assessment of Zinc Phenolsulfonate
Author:
Cosmetic Ingredient Review panel
Year:
1986
Bibliographic source:
JOURNAL OF THE AMERICAN COLLEGE OF TOXICOLOGY,Volume 5, Number 5, 1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To evaluate the skin sensitizing potential of Zinc bis(4-hydroxybenzenesulfonate) in Hartley albino guinea pigs by Buehler test.
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
Not specified.

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc bis(4-hydroxybenzenesulfonate
Cas Number:
127-82-2
Molecular formula:
C6H6O4S.1/2Zn
IUPAC Name:
Zinc bis(4-hydroxybenzenesulfonate
Details on test material:
- Name of test material (as cited in study report): Zinc Phenolsulfonate
- Molecular formula (if other than submission substance): C6H6O4S.1/2Zn
- Molecular weight (if other than submission substance): 411.725g/mol
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material (as cited in study report): Zinc Phenolsulfonate
- Molecular formula (if other than submission substance): C6H6O4S.1/2Zn
- Molecular weight (if other than submission substance): 411.725g/mol
- Substance type: Organic

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Remarks:
albino
Sex:
not specified
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
other: Ethanol
Concentration / amount:
0.5 ml dose of a 16% (w/v)
Day(s)/duration:
6 hour
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: Acetone.
Concentration / amount:
16% (w/v) solution
Day(s)/duration:
24 and 48 h
No. of animals per dose:
Test group-20 animals
Control group-10 animals
Details on study design:
Details on study design
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period:6 hour
- Test groups:20
- Control group:10
- Site: A test material was applied to the clipped back skin of the test animals.
- Frequency of applications: No data available
- Duration: 6 hour
- Concentrations: 16% (w/v)
.

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2-week
- Exposure period: 24 and 48 hour
- Test groups: 20
- Control group:10
- Site: A test material was applied to the clipped back skin of the test animals.
- Concentrations: 16% (w/v)
- Evaluation (hr after challenge): 24 and 48 hourafter patch removal.
Challenge controls:
Yes 10 control animals were used.
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: challenge
Hours after challenge:
24
Group:
test chemical
Dose level:
16% (w/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin sensitization effects were observed.
Remarks on result:
no indication of skin sensitisation
Reading:
other: Challenge
Hours after challenge:
48
Group:
test chemical
Dose level:
16% (w/v)
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No skin sensitization reaction was observed.
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

No skin sensitization reaction was observed.

Applicant's summary and conclusion

Interpretation of results:
other: Non sensitizing.
Conclusions:
Zinc bis(4-hydroxybenzenesulfonate (127-82-2) was observed for its skin sensitizing potential in Hartley albino guinea pigs by Buehler test. Zinc bis(4-hydroxybenzenesulfonate (127-82-2) was considered to be not sensitizing in in Hartley albino guinea pigs by Buehler test.
Executive summary:

Zinc bis(4-hydroxybenzenesulfonate (127-82-2)was assessed for its possible contact allergenic potential. For this purpose Buehler test was performed on a group of 20 Hartley albino guinea pigs. In induction exposure 0.5 ml dose of a 16% (w/v) of test material and ethanol as a vehicle was applied to the clipped back skin of the test animals. Three exposures of 6 h each comprised the induction phase. After a 2-wee of rest period, a challenge patch was applied to the site using a 16% (w/v) solution of the test material in acetone. The test sites were scored 24 and 48 h after application of the challenge patch. No sensitization reactions were reported. ThereforeZinc bis(4-hydroxybenzenesulfonate (127-82-2) was considered to be non sensitizing in Hartley albino guinea pigs by Buehler test.