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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable publication, however, exact source of data not known, data for different chemicals compiled from differend labs and companies in paper

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
1996
Reference Type:
secondary source
Title:
No information
Author:
Bagley DM et al.
Year:
1995
Bibliographic source:
ECETOC 1995, Skin Irritation and Corrosion: Reference Chemicals data bank, TR No. 66, 1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
company not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Citronellol
EC Number:
203-375-0
EC Name:
Citronellol
Cas Number:
106-22-9
Molecular formula:
C10H20O
IUPAC Name:
3,7-dimethyloct-6-en-1-ol
Details on test material:
- Analytical purity: 98.7%

Test animals

Species:
rabbit
Strain:
other: albino

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 98.7%
Duration of treatment / exposure:
4 hrs
Observation period:
24, 48 and 72 hrs
Number of animals:
dl-citronellol was tested three times: 3 rabbits in single-patch study (Test A) and twice 4 rabbits in multi-patch study (Test B, C)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 - 72 h
Score:
3.67 - 4.22
Max. score:
8
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: Test A, B, C
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: Test A
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2.2
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: Test A
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: Test B
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: Test B
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: Test C
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
other: Test C

Any other information on results incl. tables

Results Test (A):

Readings Animal Exposure period: 4 h
Erythema Edema Additional findings
1h 1 1 2  
2 2 2  
3 1 2  
24 h 1 2 2  
2 2 2  
3 2 2  
48 h 1 2 2  
2 2 3  
3 2 2  
72 h 1 2 2  
2 2 3  
3 2 2  
7 d 1 2 2 D*
2 2 1 D 
3 2 2 D*
Mean 24 - 72 h 1 2 2  
2 2 2.7  
3 2 2  
Mean   2 2.2  

Results Test (B):

Readings Animal Exposure period: 4 h
Erythema Edema Additional findings
1h 1 2 2  
2 2 2  
3 2 1  
4 1 1  
24 h 1 2 3  
2 2 2  
3 2 2  
4 2 1  
48 h 1 2 3  
2 2 3  
3 2 1  
4 2 1  
72 h 1 2 2  
2 2 3  
3 2 1  
4 2 2  
7 d 1 2 1 D
2 2 1  
3 2 1 D
4 1 1 D
Mean 24 - 72 h 1 2 2.7  
2 2 2.7  
3 2 1.3  
4 2 1.3  
Mean   2 2  

Results Test (C):

Readings Animal Exposure period: 4 h
Erythema Edema Additional findings
1h 1 2 1  
2 2 1  
3 1 1  
4 1 1  
24 h 1 2 2  
2 2 2  
3 2 2  
4 2 2  
48 h 1 2 2  
2 2 2  
3 2 1 sD
4 2 1  
72 h 1 2 2  
2 2 2  
3 2 1 sD
4 2 1  
7 d 1 1 1  
2 1 1  
3 0 0 D*
4 2 2 D*
Mean 24 - 72 h 1 2 2.0  
2 2 2.0  
3 2 1.3  
4 2 1.3  
Mean   2 2  

sD: slight desquamation from skin surface

D: desquamation from skin surface

D*: marked desquamation from skin surface

Summary:

 Test: susbtance  Purity (%)  # animals tested  PDII  Mean erythema score  Mean edema score
 (A): dl-citronellol  98.7  3  4.22  2  2.2
 (B): M dl-citronellol  98.7  4  4.0  2  2
(C): M dl-citronellol 98.7   4  3.67  2  2

M = tested in multi-patch study

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU