Registration Dossier

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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
company not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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