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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
Study period:
March 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Justification for type of information:
This information is used for read-across to Neryl acetate multi

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)
Version / remarks:
1981/1992
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Linalyl acetate
EC Number:
204-116-4
EC Name:
Linalyl acetate
Cas Number:
115-95-7
Molecular formula:
C12H20O2
IUPAC Name:
1,5-dimethyl-1-vinylhex-4-en-1-yl acetate

Test animals

Species:
rabbit
Strain:
other: Albino strain
Details on test animals or test system and environmental conditions:
Within guideline specifications

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL/kg bw

Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
7
Details on study design:
SCORING:
Scoring according to guideline OECD 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
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
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
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
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
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
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: #7
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: #7
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Slight or marked desquimation of the skin was noted in 6 out 7 rabbits after the 7 days oberservation period.

Applicant's summary and conclusion

Interpretation of results:
other: Skin irritant Cat. 2
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Executive summary:

For Linalyl acetate anin vivo skin irritation studyis available according to OECD TG 404 (Rel. 1). In this study, 0.5 mL undiluted Linalyl acetate was applied semi-occlusive for 4 hours to intact rabbit skin in 7 rabbits, observations were made 1, 24, 48 and 72 hours and 7 days after removal of the test item. Erythema and Edema scores averages on the first 3 days were 1.9 and 1.2, respectively. Absence, mild and moderate desquamation from skin surface was seen in 1, 3 and 3 animals, respectively, at day 7, the final observed day. Although the observation time was not extended to investigate reversibility, the severity of the skin effects decreased for most rabbits in the first week after exposure. Not based on the scores, during the first 3 days but based on the desquamation findings at day 7 the substance is an irritant but not corrosive to skin.