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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
study acquired from reliable secondary source therefore no detailed documentation.
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
study acquired from reliable secondary source therefore no detailed documentation.
Justification for type of information:
The read across justification is presented in the irritation / corrosion endpoint summary and the accompanying files are also attached there.
Reason / purpose:
read-across source
Irritation parameter:
erythema score
Remarks:
Test 1
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 1
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 1
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 1
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 1
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 1
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 2 (multi patch)
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 2 (multi patch)
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 2 (multi patch)
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 2 (multi patch)
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 2 (multi patch)
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 2 (multi patch)
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 2 (multi patch)
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 2 (multi patch)
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 3 (multi patch)
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 3 (multi patch)
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 3 (multi patch)
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 3 (multi patch)
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 3 (multi patch)
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 3 (multi patch)
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 3 (multi patch)
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 3 (multi patch)
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Interpretation of results:
other: Irritating to skin (Category 2)
Remarks:
Based on CLP criteria (EC 1272/2008 and its updates)
Conclusions:
Under the test conditions (OECD 404 and GLP) the test substance is considered to be a skin irritant.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified
Remarks:
Albino
Details on test animals and environmental conditions:
Not specified.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: 100%
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
Test 1: 3 animals
Test 2: 4 animals
Test 3: 4 animals
Details on study design:
Multi patch studies were selected for this publication because the multi-patch studies were assumed not to contravene with OECD Test Guideline 404. Additionally, no interference was reported between reactions on different patch sites in the multi-patch studies.

TEST SITE
- Area of exposure: Flank
- % coverage: Not specified
- Type of wrap if used: Semi-occlusive patches (multi-patch)

OBSERVATION TIME POINTS
After 1, 24, 48, 72h and 7 days.

SCORING SYSTEM: according to Draize (adopted by OECD TG 404)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Test 1
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 1
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 1
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 1
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 1
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 1
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 2 (multi patch)
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 2 (multi patch)
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 2 (multi patch)
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 2 (multi patch)
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 2 (multi patch)
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 2 (multi patch)
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 2 (multi patch)
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 2 (multi patch)
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 3 (multi patch)
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 3 (multi patch)
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 3 (multi patch)
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 3 (multi patch)
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 3 (multi patch)
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 3 (multi patch)
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Remarks:
Test 3 (multi patch)
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Remarks:
Test 3 (multi patch)
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
De = desquamation from skin surface (De* = marked) (Des = slight)

Test 1:
- On Day 7 the following observations were reported for animal 1, 2, and 3: De*, De, and De*, respectively.
Test 2:
- On day 7 the following observations were reported for animal 1, 2, 3, and 4: De, none, De, and De, respectively.
Test 3:
- After 48 and 72h the following observations were reported for animal 1, 2, 3, and 4: none, none, Des, and none, respectively.
- On day 7 the following observations were reported for animal 1, 2, 3, and 4: none, none, De*, and De*, respectively.

Applicant's summary and conclusion

Interpretation of results:
other: Irritating to skin (Category 2)
Remarks:
Based on CLP criteria (EC 1272/2008 and its updates)
Conclusions:
Under the test conditions (OECD 404 and GLP) the test substance is considered to be a skin irritant.
Executive summary:

The skin irritation potential of Citronellol has been tested according to OECD TG 404. Two multi patch test were performed with 4 rabbits each and one single patch test was performed with 3 rabbits. All studies were performed with 0.5 mL undiluted test substance applied on the flank for 4 hours under semi-oclussive conditions. The animals were observed for 7 days after exposure and skin irritation was scored according to the Draize scoring system. Under the conditions of the test the substance was found to be skin irritating.