Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: 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 journals

Data source

Reference
Reference Type:
publication
Title:
Fragrance raw materials monographs: 2-Nonanone
Author:
Edited by D.L.J Opdyke
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 irritation test was performed for Methyl heptyl ketone in rabbit over a period of 24 hour by patch test method.
GLP compliance:
no

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
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): 2-nonanone
- Molecular formula: C9H18O
- Molecular weight: 142.24g/mol
- Smiles notation: C(CCCCC)CC(C)=O
- InChI: 1S/C9H18O/c13456789(2)10/h38H2,12H3
- Substance type: Organic
- Physical state: colorless to pale yellow clear oily liquid

Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-nonanone
- Molecular formula: C9H18O
- Molecular weight: 142.24g/mol
- Smiles notation: C(CCCCC)CC(C)=O
- InChI: 1S/C9H18O/c13456789(2)10/h38H2,12H3
- Substance type: Organic
- Physical state: colorless to pale yellow clear oily liquid

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data available

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Undiluted material was applied on the skin.
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
>5000 mg/kg
Duration of treatment / exposure:
24 hour
Observation period:
24 hour
Number of animals:
no data available
Details on study design:
No data available

Results and discussion

In vitro

Other effects / acceptance of results:
no data available

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Reversibility:
not specified
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
Irritation effects and scaly skin was observed at necropsy in the test animals.
Based on the observations, 2-nonanone can be considered as a skin irritant.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Irritation effects and scaly skin was observed at necropsy in rabbits.
Based on the observations, 2-nonanone can be considered as a skin irritant.
Executive summary:

A skin irritation study was performed as a part of Acute dermal toxicity study in rabbits to evaluate the irritation potential of 2-nonanone.

5.0g/kg of undiluted 2-nonanone was applied under occlusion patch test to rabbits for 24 hours. Irritation effects and scaly skin was observed at necropsy in rabbits.

Based on the observations, 2-nonanone can be considered as a skin irritant.