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Toxicological information

Skin sensitisation

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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 publication.

Data source

Reference
Reference Type:
publication
Title:
Skin sensitization potential of the test chemical
Author:
Griffith et al
Year:
1972
Bibliographic source:
Arch Derm. 1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Skin Sensitisation study was conducted by using the given test chemical.
GLP compliance:
not specified
Type of study:
other: Human Patch Test
Justification for non-LLNA method:
The study was performed on Human subjects to assess the sensitizing potential of the test chemical.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: granular
Details on test material:
- Name of the test chemical : Fluorescent Brightener 220
- Molecular formula: C40H40N12O16S4.4Na
- Molecular weight: 1165.048 g/mol
- Substance type: Organic
- Smiles: [Na+].[Na+].[Na+].[Na+].OCCN(CCO)c1nc(Nc2ccc(cc2)S(=O)(=O)[O-])nc(Nc3ccc(\C=C\c4ccc(Nc5nc(Nc6ccc(cc6)S(=O)(=O)[O-])nc(n5)N(CCO)CCO)cc4S(=O)(=O)[O-])c(c3)S(=O)(=O)[O-])n1

In vivo test system

Test animals

Species:
other: Human
Strain:
other: not applicable
Sex:
not specified
Details on test animals and environmental conditions:
No Data Available

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: soap plus borate solution
Concentration / amount:
3% of the test chemical
Day(s)/duration:
21 Days
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: soap plus borate
Concentration / amount:
Not Specifed
Day(s)/duration:
24 hours
Adequacy of challenge:
not specified
No. of animals per dose:
72 subjects
Details on study design:
No Data Available
Challenge controls:
Soap plus borate
Positive control substance(s):
no

Results and discussion

Positive control results:
No Data Available

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
3% of the test chemical
No. with + reactions:
0
Total no. in group:
72
Clinical observations:
No Clinical observations were seen in the subjects.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not Sensitizing
Conclusions:
Based on all the observations and results, it was concluded that the test chemical was not considered to be sensitizing to the human subject, and is thus not likely to be classified for sensitization as per CLP.
Executive summary:

A skin sensitization study was performed using the test chemical on human subjects so as to identify the sensitizing potential of the test chemical. The test material (3% of the test chemical in a soap plus borate solution was applied under occlusive patches in a series of 9 applications (each of 24 hours' duration) during a 3 week period to 72 human subjects. Challenge applications were made 2 weeks later. The vehicle also was applied as a negative control. No positive control was applied. The test application sites were graded for primary irritation at various intervals. The material did not appear to cause irritation. None of the subjects were sensitized. Hence, based on all the observations and results, it was concluded that the test chemical was not considered to be sensitizing to the human subject, and is thus not likely to be classified for sensitization as per CLP.