Lavandula hybrida oil, light fraction

Endpoint summary

Description of key information

In an in vivo eye irritation study (Draize test) linalool was considered irritant to the eyes (troy 1977)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

Classification based on calculation rules for mixtures of the CLP Regulation

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

Classification based on calculation rules for mixtures of the CLP Regulation
Constituants data come from an online compilation using secondary data sources. There is no experimental study reference, however data is cited in the database as peer reviewed.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Classification based on calculation rules for mixtures of the CLP Regulation

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

ECETOC Irritation Chemical Reference Databank

Type of coverage:

not specified

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #1

Remarks:

3 animals

Time point:

other: no data

Score:

3.33

Reversibility:

not specified

Remarks on result:

other: linalol purity 97.1%

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #2

Remarks:

4 animals

Time point:

other: no data

Score:

3.42

Reversibility:

not specified

Remarks on result:

other: linalol purity 97.1%

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #3

Remarks:

4 animals

Time point:

other: no data

Score:

2.08

Reversibility:

not specified

Remarks on result:

other: linalol purity 97.1%

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Linalool is classified as a skin irritant substance according to CLP and GHS criteria.
No study was conducted on the lavandin oil light fraction iself.
The test item is a natural complex substance (NCS). It is a mixture of several constituents, and linalool represents 65% of this UVCB substance.
Literature above provided data for this major compound.

Executive summary:

The NCS is composed of several identified constituents, so it can be considered as a mixture according to the definition of the CLP Regulation. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2015) was used to determine the skin irritation / corrosion potential of the registered substance.

The registered substance has not been tested itself in appropriate in vitro or in vivo tests.

But one of its constituents is classified as skin irritant (Linalool at 65%) and none other constituents is assessed corrosive.

The single constituent is present above the CLP generic concentration limit of 10% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin irritant substance without further testing according to the Regulation (EC) No 1272/2008.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

weight of evidence

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

other: Draize test

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

several seconds to allow the liquid to mix with the eye fluids

Observation period (in vivo):

24h, 48 h, 72h and at day 4 and day 7

Number of animals or in vitro replicates:

6

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

27

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Score:

16

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

10

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4 days

Score:

6

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

0

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Linalool is classified as a eye irritant substance according to CLP and GHS criteria.
No study was conducted on the lavandin oil light fraction iself.
The test item is a natural complex substance (NCS). It is a mixture of several constituents, and linalool represents 65% of this UVCB substance.
Literature above provided data for this major compound.
Hence, lavandin oil light fraction is classified as a eye irritant substance according to CLP and GHS criteria.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

SKIN IRRITATION :

The NCS is composed of several identified constituents, so it can be considered as a mixture according to the definition of the CLP Regulation. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2015) was used to determine the skin irritation / corrosion potential of the registered substance.

The registered substance has not been tested itself in appropriate in vitro or in vivo tests.

But one of its constituents is classified as skin irritant (Linalool at 65%) and none other constituents is assessed corrosive.

The single constituent is present above the CLP generic concentration limit of 10% that triggers classification of the mixture. Therefore, the registered substance is classified as a skin irritant substance without further testing according to the Regulation (EC) No 1272/2008.

EYE IRRITATION :

The NCS is composed of several identified constituents and in that, it can be considered as a mixture according to the definition of the CLP Regulation. The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2015) was used to determine the eye irritation/corrosion potential of the registered substance.

The registered substance has not been tested itself in appropriate in vitro or in vivo tests but some of its constituents are classified as eye irritant (Linalool at 65%) and are all potentially present above the CLP generic concentration limit of 10% that triggers classification of the mixture. Therefore, the registered substance is classified as a eye irritant substance without further testing according to the Regulation (EC) No 1272/2008.