Registration Dossier

Administrative data

Description of key information

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.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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 .
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
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
Species:
other: Human
Strain:
not specified
Remarks:
Not applicable
Sex:
not specified
Details on test animals and environmental conditions:
No data available
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
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
Statistics:
No data available
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
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.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization 

In different studies, 4-Nonylphenol, branched, ethoxylated (127087-87-0) has been investigated for potential of skin sensitization to a greater or lesser extent. These studies are based on in vivo experiments in human and guinea pig for target chemical 4-Nonylphenol, branched, ethoxylated. The predicted data using the OECD QSAR toolbox has also been compared with the experimental data of target chemical.

Skin sensitization study was conducted by ICI Surfactant (ICI Surfactant Toxicology Summery report, OTS0558989, 1997) to evaluate the skin sensitization potential of

4-Nonylphenol, branched, ethoxylated on Human.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.

Other study conducted by Cosmetic Ingredient Review (CIR, Safety Assessment of Nonoxynols as Used in Cosmetics. 2015) to evaluate the skin sensitization potential of 4-Nonylphenol, branched, ethoxylated on Human..A group of 25 male and 25 female were observed for skin sensitization effect by using Human Repeated Insult Patch Tests (HRIPT).The test substance was placed on back of each volunteer as Discs (1.25diameter)saturatedwith sample as occlusive patch . A primary patch was kept for 48 hour. In induction phase 14 induction patches applied for 24hr. After two weeks rest period challenge application for 24hr carried out using occlusive patch. No immediate or delayed skin sensitization reaction was observed among both sex of 25 human volunteer. So4-Nonylphenol, branched, ethoxylated  (127087-87-0)was considered as non-skin sensitizing.

In another prediction done by SSS (2017) using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the six closest read across substances ,the skin sensitizing potential was estimated for 4-Nonylphenol, branched, ethoxylated. Based on the predicti 4-Nonylphenol, branched, ethoxylated (127087-87-0) was estimated to be non sensitizing to the skin of male Hartley guinea pig.

Further ,supported by the experimental data conducted by UNION CARBIDE CHEMICALS AND PLASTICS COMPANY INC.(OTS0536096, 1992) to evaluate the skin sensitization potential of target substance in Guinea pig.Guinea pig maximization test was carried out using Nonylphenol, branched, ethoxylated on Dunkin-Hartley female guinea pig. The animals were group as test, positive control and control as 10, 4, 4 respectively. For induction test solution given intradermal and topical while challenge given by topical only. Also formalin for induction 5% and challenge 2 % used as positive control Animals were exposed for induction. After rest period of 7 day challenge given as only one exposure for a period of 48 hr. Both induction and challenge solution are undiluted. After 48hr, Erythema observed in left side of5/9 test animals, 4/4 positive control group and 2/4 control group. According to the 48 hr. readings the allergenic potency is gradeIII (moderate) but an irritant contribution to the observed erythema is not unequivocally excluded. The test substance will be diluted for re-challenge. In this study one animal was killed following the discovery of a septic wound on one foreleg. The re-challenge test conducted. After 21 days of induction test. The test sample diluted as 1in 5 and 1 in 20 given as same way as challenge exposure. Formalin for induction 5%. Re-challenge 0.4%and 0.1% was used as positive control. After 48hr erythema was observed in the right side of 3/9 test animals, 4/4 positive control and 0/4 in control for1 in 5 dilution group while erythema was observed in the left side of 1/9test animals, 4/4 positive control,0/4 in control in 1 in 20 dilution group . From above result Nonylphenol, branched, ethoxylated was considered to be mild to moderate sensitizing to skin of guinea pig.

Thus based on the majority of experimental studies, well supported by prediction andapplying weight of evidence, it can be concluded that4-Nonylphenol, branched, ethoxylated is not a skin sensitizer. Thus comparing the majority of above annotations with the criteria of CLP regulation, 4-Nonylphenol, branched, ethoxylated (127087-87-0) can be considered as not classified for skin sensitization.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

By comparing the majority of above annotations with the criteria of CLP regulation, 4-Nonylphenol, branched, ethoxylated (127087-87-0)can be considered as 'not classified' for skin sensitization effect .