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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
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:
Fragrance raw materials monographs: 2-nonanone
Author:
Moreno, O. M.
Year:
1988
Bibliographic source:
Food and Chemical Toxicology Volume 26, Issue 4, 1988, Pages 393

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Skin sensitization test was performed for Nonan-2-one humans by using maximization test.
GLP compliance:
no
Type of study:
other: Human maximization test

Test material

Constituent 1
Chemical structure
Reference substance name:
Nonan-2-one
EC Number:
212-480-0
EC Name:
Nonan-2-one
Cas Number:
821-55-6
Molecular formula:
C9H18O
IUPAC Name:
nonan-2-one
Constituent 2
Reference substance name:
Methyl heptyl ketone
IUPAC Name:
Methyl heptyl ketone
Details on test material:
- Name of test material (as cited in study report): 2-nonanone
- Molecular formula (if other than submission substance):
C9H18O
- Molecular weight (if other than submission substance):
142.24g/mol
- Substance type: Organic
- Physical state: colorless to pale yellow clear oily liquid
- Purity : No data available
- Impurities (identity and concentrations): No data available
Specific details on test material used for the study:
Details on test material
- Name of test material (as cited in study report): 2-nonanone
- Molecular formula:C9H18O
- Molecular weight: 142.24g/mol
- Substance type: Organic

In vivo test system

Test animals

Species:
human
Strain:
not specified
Remarks:
Not applicable.
Sex:
not specified
Details on test animals and environmental conditions:
No data available

Study design: in vivo (non-LLNA)

Induction
Route:
other: No data available
Vehicle:
petrolatum
Concentration / amount:
5%
Adequacy of induction:
other: This test concentration was based on a reported maximum concentration of 0.5%in consumer products
Challenge
Route:
other: No data available
Vehicle:
petrolatum
Concentration / amount:
5%
Adequacy of challenge:
other: This test concentration was based on a reported maximum concentration of 0.5%in consumer products
No. of animals per dose:
35 human volunteers
Details on study design:
No data available
Challenge controls:
No data available
Positive control substance(s):
not specified

Study design: in vivo (LLNA)

Statistics:
No data available.

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
35
Clinical observations:
No sensitization was observed.
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

No sensitization was observed.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
Nonan-2-one was evaluated for its skin sensitizing potential in human by Human maximization test. 2-nonanone was considered to be non sensitizing in human.
Executive summary:

Skin sensitization study for Nonan-2-one (821-55-6)was observed in 35human volunteers by Human maximization test. No skin sensitization effect was observed. Therefore Nonan-2-one (821-55-6)was considered to be non sensitizing in human byHuman maximization test.