Registration Dossier

Administrative data

Description of key information

Skin sensitisation:

4-Nonylphenol, ethoxylated (26027-38-3) was assessed for its possible allergic contact dermatitis reaction in humans from International Journal of Toxicology, 18(Suppl. 1):l I-31, 1999. 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.

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:
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.
Qualifier:
according to
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
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
Details on study design:
No data available
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
- 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.
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)
Route:
epicutaneous, occlusive
Vehicle:
other: Mineral oil
Concentration / amount:
0.2 ml
Day(s)/duration:
21 days (3 weeks)
Adequacy of induction:
not specified
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
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
Key result
Reading:
other: challenge
Hours after challenge:
96
Group:
test group
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

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).

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.

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

Skin sensitization 

In different studies, 4-Nonylphenol, ethoxylated (26027-38-3) has been investigated for potential of skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in human for target chemical 4-Nonylphenol, ethoxylated (26027-38-3).

4-Nonylphenol, ethoxylated (26027-38-3) was assessed for its possible allergic contact dermatitis reaction in humans from International Journal of Toxicology, 18(Suppl. 1):l I-31, 1999. 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.

From the same reference International Journal of Toxicology, 18(Suppl. 1):l I-31, 1999 study supported to the above key study. 4-Nonylphenol, ethoxylated (26027-38-3) was assessed for its possible allergic contact dermatitis reaction in humans. 4-Nonylphenol, ethoxylated reaction was evaluated in 111 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 10% of nonoxynol 2 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 was 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). After induction test slight to moderate erythema was observed in 15 subjects and 8 additional volunteers were applied for challenge exposure. 9 out of 23 were having allergic contact dermatitis. 7 out of 9 were retested according to the other procedure. In that test substance was applied under a semi-occlusive patch for 30 minutes, after which the test site was rinsed with warm water. Reactions were observed for 24 and 48 hrs in which not allergic responses were observed in five out of seven volunteers. 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.

Thus by applying key and supporting data, it can be concluded that 4-Nonylphenol, ethoxylated (26027-38-3) is not a skin sensitizer. Thus comparing the above annotations with the criteria of CLP regulation, 4-Nonylphenol, ethoxylated (26027-38-3) can be considered as not classified for skin sensitization.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based key and supporting data, it can be concluded that 4-Nonylphenol, ethoxylated (26027-38-3) is not a skin sensitizer. Thus comparing the above annotations with the criteria of CLP regulation, 4-Nonylphenol, ethoxylated (26027-38-3) can be considered as not classified for skin sensitization.