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Administrative data

Description of key information

- Skin irritation/corrosion: irritating, based on available data and on additivity principles.
- Eye irritation: irritating, based on additivity principles.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
accepted calculation method
Qualifier:
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation
Irritation parameter:
other: classification
Remarks on result:
other: skin irritant category 2
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Executive summary:

The compound 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 (2017) was used to determine the skin irritation/corrosion hazard of the registered substance. The decision of classification as skin irritant was based on existing data on constituents (additivity principles): the registered substance has more than 10% of its constituents classified as Skin irritant Category 2 and should be classified as a skin irritant cat.2 without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

Constituent

CAS

Classification according to the Regulation (EC) No. 1272/2008 (CLP)

Source

Pinene alpha

80-56-8

Skin Irrit. 2 - H315

ECHA C&L inventory–self classification

Pinene Beta

127-91-3

Skin Irrit. 2 - H315

ECHA C&L inventory–self classification

Camphene

79-92-5

NC

ECHA C&L inventory–self classification

Limonene

138-86-3

Skin Irrit. 2 - H315

ECHA C&L inventory–self classification

 

Source: ECHA disseminated dossiers or self classification

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1972
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method according to the typical testing for acute dermal toxicity in a limit test: topical application of substance on rabbits at one high dose.
GLP compliance:
no
Remarks:
(pre-GLP)
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data
Type of coverage:
not specified
Preparation of test site:
other: 3 animals abraded + 3 animals intact
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw

Duration of treatment / exposure:
Single treatment (24 h exposure)
Observation period:
14 days
Number of animals:
Total: 6 animals
Details on study design:
No data
Irritation parameter:
other:
Remarks on result:
not determinable because of methodological limitations
Irritant / corrosive response data:
- No mortality was observed.
- Moderate erythema followed by drying and cracking and shedding of skin ( exfoliation).
Other effects:
- No other clinical signs were observed

Acute dermal LD50 of test material was higher than 5000 mg/kg bw

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions, Abies alba oil from needles induced moderate skin irritation in rabbits.
Executive summary:

In an acute dermal toxicity study (limit test), six rabbits were given a single dermal application of Abies alba oil from needle at 5000 mg/kg bw. Animals were observed for mortality, clinical signs and local reactions for 14 days.

No mortality was observed. Moderate erythema followed by drying and cracking and shedding of skin ( exfoliation).No other clinical signs were observed.

Under the test conditions, Abies alba oil from needle induced moderate skin irritation in rabbits.

This study was conducted according to a non-standard method and adequate scoring of skin effects was not provided, therefore it was not possible to take a decision on the classification based solely on this study.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
Classification based on calculation rules for mixtures of the CLP Regulation
Type of information:
calculation (if not (Q)SAR)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
accepted calculation method
Qualifier:
no guideline required
Principles of method if other than guideline:
Classification based on calculation rules for mixtures of the CLP Regulation
Irritation parameter:
other: Classification
Remarks on result:
other: Eye irritation category 2
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Executive summary:

The mixture 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 (2017) was used to determine the serious eye damage/ eye irritant hazard of the registered substance. The decision of classification as irritant to the eyes was based on existing data on constituents (additivity principles) the registered substance has more than 10% of its constituents classified as Eye irritant Category 2 and should be classified as a Eye irritant Category 2 without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

Constituent

CAS

Classification according to the Regulation (EC) No. 1272/2008 (CLP)

Source

Pinene alpha

80-56-8

NC

ECHA C&L inventory–self classification

Pinene Beta

127-91-3

NC

ECHA C&L inventory–self classification

Camphene

79-92-5

Eye Irrit. 2 – H319

ECHA C&L inventory–self classification

Limonene

138-86-3

NC

ECHA C&L inventory–self classification

Source: ECHA disseminated dossiersor self classification

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The decision logic for classification of mixtures from the ECHA Guidance R.7a (2017) was used to determine the skin irritation/corrosion and eye irritation hazards of Fir silver (Abies alba) oil.

Skin irritation/corrosion:

The decision of classification was based on the following arguments:

1/ Existing animal data: Skin irritation was observed in rabbits in an acute dermal toxicity study (Shelanski, 1972) at the dose of 5000 mg/kg bw. Dermal reactions noted.Adequate scoring of skin effects was not provided, therefore it was not possible to take a decision on the classification based solely on this study. However, based on these data, the test substance is considered as not corrosive to skin.

2/ Existing data on constituents (additivity principles):

- all Fir silver oils having equal or more than 10% of their constituents classified as Skin irritant Category 2 should be classified as skin irritant without further testing according to the Regulation (EC) No 1272/2008.

Eye irritation:

Fir silver oil has not been tested itself, but there are sufficient data on its individual ingredients to adequately characterize the hazard of the mixture. Additivity principles were therefore applied:

- all Fir silver oils having equal or more than 10% of their constituents classified as Eye irritant Category 2 should be classified as eye irritant without further testing according to the Regulation (EC) No 1272/2008.

Constituent

CAS

Skin irritation / Classification according to the Regulation (EC) No. 1272/2008 (CLP)

Eye irritation/Classification according to the Regulation (EC) No. 1272/2008 (CLP)

Source

Pinene alpha

80-56-8

Skin Irrit. 2 - H315

NC

ECHA C&L inventory–self classification

Pinene Beta

127-91-3

Skin Irrit. 2 - H315

NC

ECHA C&L inventory–self classification

Camphene

79-92-5

NC

Eye Irrit. 2 – H319

ECHA C&L inventory–self classification

Limonene

138-86-3

Skin Irrit. 2 - H315

NC

ECHA C&L inventory–self classification

Bornyl acetate laevo

5655-61-8

NC

NC

ECHA C&L inventory–self classification



Justification for classification or non-classification

Harmonized classification:

Fir silver oil has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the typical composition provided by the Lead Registrant, Fir silver oil is classified as skin irritant:

- Skin Irritant Category 2 (H315: Causes skin irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Based on the typical composition provided by the Lead Registrant, Fir silver oil is also classified as eye irritant:

- Irritating to eyes Category 2 (H319: Causes serious eye irritation) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

No information was available regarding respiratory irritation.