Linalyl propionate

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:

: Obseravtions 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:

Grey literature: pre-dates the introduction of GLP

Test material

Test material information

Constituent 1

Reference substance name:

Linalyl propionate

EC Number:

205-627-5

EC Name:

Linalyl propionate

Cas Number:

144-39-8

Molecular formula:

C13H22O2

IUPAC Name:

3,7-dimethylocta-1,6-dien-3-yl propanoate

impurity 1

Reference substance name:

Unknown impurities

Molecular formula:

not applicable

IUPAC Name:

Unknown impurities

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No information available

Test system

Type of coverage:

not specified

Preparation of test site:

other: Abraded and unabraded sites

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:

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

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 propionate 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: 24h

Score:

1

Max. score:

4

Reversibility:

other: reversible in one rabbit by 72 hours

Remarks on result:

other: Grade 1-2 erythema observed in all animals

Results 2

Irritation parameter:

erythema score

Remarks:

(undiluted / non abraded)

Basis:

mean

Time point:

other: 72 h

Score:

1

Max. score:

4

Reversibility:

other: reversible in one rabbit by 72 hours

Remarks on result:

other: Grade 1-2 erythema observed in all animals

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

Other effects:

None reported

Any other information on results incl. tables

Undiluted linalyl propionate
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	1	1	1	1	1	0	1	2	0	1	2
Oedema	0	0	0	0	0	0	0	0	0	0	0	0

 

Diluted linalyl propionate (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	0	0	1	0	0	1	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 propionate caused mild skin irritation (Grade 1or 2 erythema) when applied to abraded and non-abraded sites on rabbit skin. No oedema was observed. Although full reversibility of effects was not demonstrated within the 72 hour period, effects are not considered to be of sufficient severity to warrant classification according to the CLP Regulation.

Executive summary:

0.5 mL linalyl propionate (undiluted and as a 5% dilution in diethyl phthalate) was applied to abraded and non-abraded sites of skin of three rabbits. Dermal reactions were assessed at 24 and 72 hours after application, using the Draize scale. Non-abraded and abraded skin sites showed comparable responses to undiluted linalyl propionate. At the 24 hour time point, Grade 1 erythema was observed in all animals. Erythema had resolved in one animal, remained the same severity in one animal and increased in severity to Grade 2 in one animal at the 72 hours (final) observation. No oedema was observed in any animal or at any time point. Non-abraded and abraded skin sites showed comparable responses to diluted linalyl propionate. Findings were limited to Grade 1 erythema in one animal at the 24 hour observation; effects had resolved by the next (and final) observation at 72 hours. No oedema was observed in any animal or at any time point.    Although full reversibility of effects was not demonstrated within the 72 hour period, effects are not considered to be of sufficient severity to warrant classification according to the CLP Regulation.