Pelargonium graveolens, ext.

Skin irritation / corrosion

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 for cross-reference:

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 for cross-reference:

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

1

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

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

not specified

Remarks:

Albino

Details on test animals or test system 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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Results 9

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

Results 10

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

Results 11

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

Results 12

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

Results 13

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

Results 14

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

Results 15

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

Results 16

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

Results 17

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

Results 18

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

Results 19

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

Results 20

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

Results 21

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

Results 22

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.