Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 500-045-0 | CAS number: 26027-38-3 1 - 2.5 moles ethoxylated
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Amended Final Report on the Safety Assessment of Nonoxynol-1, -2, -3, -4, -5, -6, -7, and -8.
- Author:
- Cosmetic Ingredient Review
- Year:
- 1 999
- Bibliographic source:
- International Journal of Toxicology, 18(Suppl. 1):l I-31, 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Draize Repeat Insult Patch Test was performed in 110 volunteers to observe the allergic contact dermatitis.
- GLP compliance:
- not specified
- Type of study:
- other: Modification of the Draize Repeat Insult Patch Test
- Justification for non-LLNA method:
- Not specified
Test material
- Reference substance name:
- 4-Nonylphenol, ethoxylated
- EC Number:
- 500-045-0
- EC Name:
- 4-Nonylphenol, ethoxylated
- Cas Number:
- 26027-38-3
- Molecular formula:
- (C2-H4-O)mult-C15-H24-O
- IUPAC Name:
- 4-Nonylphenol, ethoxylated
- Test material form:
- liquid
- Details on test material:
- - Name of test material: 4-Nonylphenol, ethoxylated
- Molecular formula: C17 H28 O2
- Molecular weight: 264.40 g/mol
- Smiles: CCCCCCCCCc1ccc(OCCOCCO)cc1
- Substance type: organic
- Physical state: Liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: 4-Nonylphenol, ethoxylated
- Molecular formula: C17H28O2
- Molecular weight: 264.40 g/mol
- Smiles: CCCCCCCCCc1ccc(OCCOCCO)cc1
- Substance type: organic
- Physical state: Liquid
In vitro test system
- Details on the study design:
- No data available
In chemico test system
- Details on the study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: after every 48 hrs patch removal
- Test groups: 102 human volunteers
- Control group: No data available
- Site: scapular region of the back
- Frequency of applications: three times per week for 3 weeks (9 induction applications)
- Duration: 3 weeks
- Concentrations: 0.2 ml
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: after 5 weeks
- Exposure period: sites were observed after 48 and 96 hrs.
- Test groups: 102 human volunteers
- Control group: No data available
- Site: new sites in the scapular region of the back
- Concentrations: No data available
- Evaluation (hr after challenge): sites were observed after 48 and 96 hrs.
OTHER:
The induction phase was followed by a 14-day non treatment period.
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- other: not applicable
- Sex:
- male/female
- Details on test animals and environmental conditions:
- - Age at study initiation: 110 volunteers (9 males,101 females; 19 to 61 years old)
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Mineral oil
- Concentration / amount:
- 0.2 ml
- Day(s)/duration:
- 21 days (3 weeks)
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Mineral oil
- Concentration / amount:
- 0.2 ml
- Day(s)/duration:
- 4 days
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 102 human volunteers
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: after every 48 hrs patch removal
- Test groups: 102 human volunteers
- Site: scapular region of the back
- Frequency of applications: three times per week for 3 weeks (9 induction applications)
- Duration: 3 weeks
- Concentrations: 0.2 ml
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: after 5 weeks
- Exposure period: sites were observed after 48 and 96 hrs.
- Test groups: 102 human volunteers
- Site: new sites in the scapular region of the back
- Evaluation (hr after challenge): sites were observed after 48 and 96 hrs.
OTHER:
The induction phase was followed by a 14-day non treatment period. - Statistics:
- No data available
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: challenge
- Hours after challenge:
- 96
- Group:
- test chemical
- Dose level:
- 0.2 ml of 5% in mineral oil
- No. with + reactions:
- 3
- Total no. in group:
- 110
- Clinical observations:
- Faint to moderate erythema was observed during induction phase in 3 subjects and also at challenge phase but no evidence of allergic contact dermatitis was observed.
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
During induction and challenge phases, reactions were scored according to the following scale: 0 (no reaction) to 4 (bullae or extensive erosions involving at least 50% of the test area).
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- 4-Nonylphenol, ethoxylated (26027-38-3) was observed for its skin sensitizing potential in human volunteers. 4-Nonylphenol, ethoxylated was considered to be non sensitizing in humans.
- Executive summary:
4-Nonylphenol, ethoxylated (26027-38-3) was assessed for its possible allergic contact dermatitis reaction in humans. 4-Nonylphenol, ethoxylated reaction was evaluated in 110 human volunteers out of which 8 were drew because they were unrelated to administration of test material.
For the induction exposure, 0.2 ml of test material was applied to the scapular region of the back for three times per week for 3 weeks under occlusive patches. After 48 hrs, site was observed after removal of patches. The induction exposure duration was 3 weeks which was followed by 14-day non treatment period.
From the 6thweeks challenge exposure was applied to new sites of the scapular region of back and the site were observed after 48 and 96 hrs. During induction and challenge phases, reactions were scored according to the following scale: 0 (no reaction) to 4 (bullae or extensive erosions involving at least 50% of the test area).
Faint to moderate erythema was observed during induction phase in 3 subjects and also at challenge phase but no evidence of allergic contact dermatitis was observed.
From the clinical observation it was considered that no skin sensitization reaction was observed. Therefore 4-Nonylphenol, ethoxylated (26027-38-3) was considered to be non sensitizing in humans.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
