Registration Dossier

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:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from NTRL report .

Data source

Reference
Reference Type:
secondary source
Title:
ICI SURFACTANTS (POLYOXYETHYLENE 8 NONYLPHENOL) TOXICOLOGY SUMMARY REPORT, WITH COVER LEITER DATED 4/1/1997 (SANITIZED)
Author:
ICI Surfactant
Year:
1997
Bibliographic source:
ICI Surfactant. Toxicology Summery report, OTS0558989, 1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
To evaluate the skin sensitization potential of Poly(oxy-1,2-ethanediyl), .alpha.-(4-nonylphenyl)-.omega.-hydroxy-, branched in human.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): 4-Nonylphenol, branched, ethoxylated
- Molecular formula : C17H28O2
- Molecular weight : 264.409 g/mol
- Substance type:Organic
- Physical state: Liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4-Nonylphenol, branched, ethoxylated
- Molecular formula : C17H28O2
- Molecular weight : 264.409 g/mol
- Substance type: Organic
- Physical state: Liquid
SMILES:CCCC(C)CC(C)Cc1ccc(OCCOCCOCCOCCOCCO)cc1

In vivo test system

Test animals

Species:
other: Human
Strain:
not specified
Remarks:
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:
not specified
Concentration / amount:
one inch square piece of absorbent cotton twill and allowed to remain on the
skin
Day(s)/duration:
72 hours
Challenge
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
one inch square piece of absorbent cotton twill and allowed to remain on the
skin
Day(s)/duration:
72 hour
No. of animals per dose:
50 human volunteers
Details on study design:
Details on study design


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 72hr
- Test groups: 50
- Control group: No data available
- Site: one inch square piece of absorbent cotton twill and allowed to remain on the Skin
- Frequency of applications: No data available
- Duration:72hr
- Concentrations: No data available
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: After 7 days of rest period
- Exposure period:72 hr
- Test groups: 50
- Control group: No data available

- Site: No data available
- Concentrations: No data available
- Evaluation (hr after challenge): after 72 hr
Challenge controls:
No data available
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available

Results and discussion

In vivo (non-LLNA)

Results
Reading:
rechallenge
Hours after challenge:
72
Group:
test group
Dose level:
one inch square piece of absorbent cotton twill and allowed to remain on the Skin
No. with + reactions:
0
Total no. in group:
50
Clinical observations:
No skin sensitization effect was observed.
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
Skin sensitizing study was conducted for 4-Nonylphenol, branched, ethoxylated (127087-87-0)on 50 human volunteers. The test substancewas considered to be not sensitizing in human.
Executive summary:

Skin sensitizing study was conducted for 4-Nonylphenol, branched, ethoxylated (127087-87-0)on 50 human volunteers. The test substance was applied on skin as one inch square piece of absorbent cotton twill for 72 hours. After 72 hours, itwasremoved and the skinwasscored. Seven days after the induction exposure, the test material was reapplied in the same manner and allowed to remain on the skin for 72 hours. After 72 hours of challenge exposure the patch was removed .The skin was scored for sensitization effect. No skin sensitization was observed in any 50 volunteer. So 4-Nonylphenol, branched, ethoxylated (127087-87-0) was considered to be non-skin sensitizing in human.