Registration Dossier

Administrative data

Description of key information

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:
no guideline available
Principles of method if other than guideline:
Comparative studies on the irritancy of oils and synthetic perfumes to the skin of rabbit, guinea pig, rat, miniature swine and man (6 Angora rabbits, 6 guinea pigs and rats, 6 Miniature swines and 50 Humans, male volunteers without known allergies).
GLP compliance:
no
Specific details on test material used for the study:
Linalyl acetate, purity >95%
Species:
other: raabits, rats, guinea pigs, Miniature swine and human
Strain:
Angora
Type of coverage:
open
Preparation of test site:
clipped
Remarks:
clipped dorsal skin (3 x 3 cm)
Vehicle:
not specified
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
at 0, 24 and 72 h; after 72 h Evans blue was injected i.v., animals were killed after 1 h and dorsal skin was removed.
Observation period:
Skin reaction on living skin at 24 and 72 h; on removed skin dilation rate, oedema, capillary permeability and bleeding rate; skin histopathology.
Number of animals:
18
Irritation parameter:
overall irritation score
Basis:
animal #1
Remarks:
rabbit
Time point:
24 h
Score:
> 8
Remarks on result:
probability of severe irritation
Remarks:
In the rabbit test each animal was treated with 3 different test substances and a positive control (n-hexadecane). Two areas were left free and served as untreated controls.
Irritation parameter:
overall irritation score
Basis:
animal #1
Remarks:
rabbit
Time point:
72 h
Score:
> 8
Remarks on result:
probability of severe irritation
Remarks:
In the rabbit test each animal was treated with 3 different test substances and a positive control (n-hexadecane). Two areas were left free and served as untreated controls.

Animal scores based on erythema, oedema, dilation rate and capillary permeability:< 4 mildly irritating, 4-8 moderate irritating, > 8 severely irritating

Human scores: positive reactions < 10% non-irritating 10-40% mildly irritating, 40-70% moderate irritating,> 70% severely irritating.

 

Species

 

Rabbit

 

Guinea pig

Rat    

Miniature swine

Human 
 Result  

Severely irritating

Moderately irritating   

Not reported

 

Not irritating

Not irritating

 

remark : The method used to calculate scoring was not fully described.

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Linalyl acetate is classified as a skin irritant substance according to CLP and GHS criteria.
No study was conducted on the lavandin oil heavy fraction iself.
The test item is a natural complex substance (NCS). It is a mixture of several constituents, and linalyl acetate represents about 67% 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 (Linalyl acetate at 67%) 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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to
Guideline:
other: Draize procedure
Principles of method if other than guideline:
New Zealand female rabbits were used to evaluate the eye irritation potential of fragrance raw materials according to the Draize procedure.
GLP compliance:
no
Species:
rabbit
Strain:
other: Nex Zealand
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
unspecified; substance was not washed out
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to Draize
Scoring at: 24, 48, 72 hours, 4 days and 7 days
Irritation parameter:
overall irritation score
Remarks on result:
other: very slight conjunctival redness following treatment with linalyl acetate, which returned to normal within one day
Remarks:
100%: no effects; Mean score day 1: 0
Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
slight and reversible (<7 days) eye irritation potential can be attributed to linalyl acetate.
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 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 one of its constituents is classified as eye irritant (Linalyl acetate at 67%) and none other constituents is assessed corrosive for eyes.

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 eye irritant substance without further testing according to the Regulation (EC) No 1272/2008.

Additional information

EYE IRRITATION :

Considering the relevant eye irritation study of the metabolically related substance Linalool (CAS No. 78 -70 -6) on eye irritation (according in vivo tests), the weak irritating potential of linalyl acetate can be confirmed.

Justification for classification or non-classification

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 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 some of its constituents are classified as eye irritant (Linalyl acetate at 67%) 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.


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