Registration Dossier
Registration Dossier
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EC number: 203-931-2 | CAS number: 112-05-0
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 1976
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Human maximisation test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Nonanoic acid
- EC Number:
- 203-931-2
- EC Name:
- Nonanoic acid
- Cas Number:
- 112-05-0
- Molecular formula:
- C9H18O2
- IUPAC Name:
- nonanoic acid
- Details on test material:
- - Name of test material (as cited in study report): Pelargonic acid, Nonanoic acid
Constituent 1
Method
- Type of population:
- general
- Controls:
- no data
- Route of administration:
- dermal
Results and discussion
Any other information on results incl. tables
Reading |
1st reading |
Hours after challenge |
72 |
Group |
test group |
Dose level |
12% in petrolatum |
No. with + reactions |
|
Total no. in group |
25 |
Clinical observations |
no sensitisation occured |
Reading |
2nd reading |
Hours after challenge |
96 |
Group |
test group |
Dose level |
12% in petrolatum |
No. with + reactions |
|
Total no. in group |
25 |
Clinical observations |
no sensitisation occured |
Applicant's summary and conclusion
- Conclusions:
- Data reported in the secondary source are insufficient for assessment.
- Executive summary:
A human maximisation test was performed using 25 volunteers. The test item (purity not stated) was applied at a concentration of 12% in petrolatum. After induction (5 times patch application for 48 h) and challenge (14 days after induction, once for 48 h) exposures the summary stated that the test item produced no sensitisation reactions (Opdyke, 1978).
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.
