Linalyl formate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Grey literature deficient in some details of methodology but considered adequate for the purposes of hazard identification and classification.

Data source

Reference

Reference Type:

grey literature

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Observations made at 24 and 72 hours only; use of abraded skin sites

Principles of method if other than guideline:

Pre-dates but is broadly comparable to OECD 404

GLP compliance:

no

Remarks:

pre-dates the introduction of GLP

Test material

Test material information

Constituent 1

Reference substance name:

Linalyl formate

EC Number:

204-120-6

EC Name:

Linalyl formate

Cas Number:

115-99-1

Molecular formula:

C11H18O2

IUPAC Name:

linalyl formate

impurity 1

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

impurity 2

Reference substance name:

Linalool

EC Number:

201-134-4

EC Name:

Linalool

Cas Number:

78-70-6

Molecular formula:

C10H18O

IUPAC Name:

3,7-dimethylocta-1,6-dien-3-ol

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No further information

Test system

Type of coverage:

not specified

Preparation of test site:

other: abraded and unabraded

Vehicle:

other: The test material was applied undiluted and also as a 5% concentration in diethylphthalate

Controls:

other: Untreated intact and abraded skin sites served as controls on the same rabbits

Amount / concentration applied:

no data

Duration of treatment / exposure:

no data

Observation period:

The treated and untreated areas were observed after 24 and 72 hours for signed of irritation and were scored by the method of Draize

Number of animals:

No information available

Details on study design:

Linalyl Formate was applied to abraded and unabraded sites on rabbit skin undiluted and as a 5% concentration in diethylphthalate. Three rabbits were used for each concentration tested . Untreated intact and abraded skin served as controls on the same rabbits. The treated and untreated areas were observed after 24 and 72 hours for signed of irritation and were scored by the method of Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(undiluted / non abraded)

Basis:

mean

Time point:

other: 24 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Remarks:

(undiluted / non abraded)

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

edema score

Remarks:

(undiluted / non abraded)

Basis:

mean

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant

Remarks on result:

other: No oedema observed in any animal

Results 4

Irritation parameter:

edema score

Remarks:

(undiluted / non abraded)

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant

Remarks on result:

other: No oedema observed in any animal

Any other information on results incl. tables

Undiluted linalyl formate
Time point	24 Hours						72 Hours
Application site	Abraded			Non-abraded			Abraded			Non-abraded
Rabbit	A	B	C	A	B	C	A	B	C	A	B	C
Erythema	1	0	1	1	0	1	0	0	0	0	0	0
Oedema	0	0	0	0	0	0	0	0	0	0	0	0

 

Diluted linalyl formate (5% in diethyl phthalate)
Time point	24 Hours						72 Hours
Application site	Abraded			Non-abraded			Abraded			Non-abraded
Rabbit	A	B	C	A	B	C	A	B	C	A	B	C
Erythema	1	0	0	1	0	0	0	0	0	0	0	0
Oedema	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Undiluted linalyl formate caused mild skin irritation (Grade 1 erythema) when applied to abraded and non-abraded sites on rabbit skin. No oedema was observed. Full reversibility of effects was demonstrated within the 72 hour period, therefore the effects are not considered to be of sufficient severity to warrant classification according to the CLP Regulation.