Registration Dossier

Administrative data

Description of key information

Human Repeated Insult Patch Test (K, Rel2): not a skin sensitizer at 1%.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
Human Repeat Insult Patch Test
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, but considered sufficiently reliable for the purpose of hazard assessment.
Qualifier:
no guideline followed
Principles of method if other than guideline:
Maximization tests (Modified after JID 47393-409, 1966): Test materials were applied under occlusion to the same site on the volar forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-tested for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labeled site 5. Questionable reactions were followed on a daily basis for 1 week and retests were applied later at new sites.
GLP compliance:
no
Type of study:
other: Study with volunteers
Justification for non-LLNA method:
Available study on volunteers
Species:
other: Human
Strain:
other: non relevant
Sex:
not specified
Details on test animals and environmental conditions:
- Number of subjects recruited: 36
- Number of subjects exposed: 29
- Age: human 18+ yrs.
Positive control results:
No positive control
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
29
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Remarks on result:
other: not specified
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
other: not specified
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test material can be considered as non-sensitizing at 1%.
Executive summary:

In a Human Repeated Insult Patch Test, the primary irritation and sensitization properties of the test sample was tested on 29 volunteers. The test material (1%) was applied under occlusion to the same site on the volar forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-tested for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labeled site 5. Questionable reactions were followed on a daily basis for 1 week and retests were applied later at new sites.

No evidence of skin irritation or sensitisation was observed in the 29 subjects tested.

Under the test conditions, the test material can be considered as non-sensitizing at 1%.

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

One study was available and considered as key study (Epstein, 1976). In a Human Repeated Insult Patch Test, the primary irritation and sensitization properties of the test sample was tested on 29 volunteers. The test material (1%) was applied under occlusion to the same site on the volar forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-tested for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labeled site 5. Questionable reactions were followed on a daily basis for 1 week and retests were applied later at new sites.

No evidence of skin irritation or sensitisation was observed in the 29 subjects tested.

The test material can be considered as non-sensitizing at 1%.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self classification:

Based on the available data no additional self-classification is proposed according to the CLP and to the GHS.

No data was available for respiratory sensitisation. However, this substance is not a skin sensitizer, therefore according to Figure R.7.3 -2 of the Chapter R.7 (V 4.1 - October 2015) the chemical is not considered as a respiratory sensitizer.