Registration Dossier

Administrative data

Description of key information

- Skin irritation/corrosion: irritating, based on available data and 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: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1976
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
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 and environmental conditions:
No data
Type of coverage:
not specified
Preparation of test site:
not specified
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: 10 animals
Details on study design:
no details
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
- Slight and moderate redness was observed in 6/10 and 4/10 animals, respectively.
- Slight and moderate edema was observed in 1/10 and 9/10 animals, respectively.
Other effects:
- No mortality was observed.

None

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the test conditions, Abies Sibirica Oil induced slight to moderate skin irritation in rabbits.
Executive summary:

In an acute dermal toxicity study, ten rabbits were topically applied with a single dose of Abies Sibirica Oil at 5000 mg/kg bw. All animals were observed for mortality, clinical signs and local reactions.

No mortality occurred at the tested dose level. Slight and moderate redness was observed in 6/10 and 4/10 animals, respectively. Slight and moderate edema was observed in 1/10 and 9/10 animals, respectively.

Under the test conditions, Abies Sibirica Oil induced slight to 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 of classification based solely on this study.

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 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 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 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)

Skin irritation

Source

Pinene alpha

80-56-8

SCI2, H315

ECHA C&L inventory - self classification

Pinene Beta

127-91-3

SCI2, H315

 ECHA C&L inventory - self classification

Delta 3 carene

13466-78-9

SCI2, H315

 ECHA C&L inventory - self classification

Myrcene beta

123-35-3

SCI2, H315

 ECHA C&L inventory - self classification

Limonene

138-86-3

SCI2, H315

 ECHA C&L inventory - Harmonized Classification

Source: ECHA disseminated dossiers or self classification

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 damage category 2
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Executive summary:

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 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 skin irritant without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008.

Substance

CAS

Classification according to 1272/2008 EC Regulation

 Source

Camphene

79-92-5

H319

 ECHA C&L inventory - self classification

  

Myrcene beta

  

123-35-3

  

H319

  

ECHA C&L inventory - 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 (2013) was used to determine the skin irritation/corrosion and eye irritation hazards of Pine needle (Abies Sibirica) 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 (Moreno, 1976) at the dose of 5000 mg/kg bw. Dermal reactions noted were slight and moderate redness in 6/10 and 4/10 animals, respectively. Slight and moderate edema was observed in 1/10 and 9/10 animals, respectively.

Adequate scoring of skin effects was not provided, therefore it was not possible to take a decision of classification based solely on this study.

2/ Existing data on constituents (additivity principles):

- all Pine needle 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:

Pine needle 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 Pine needle 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

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

Source

Skin irritation

Eye irritation

Pinene alpha

80-56-8

SCI2, H315

-

ECHA C&L inventory - self classification

Pinene Beta

127-91-3

SCI2, H315

-

 ECHA C&L inventory - self classification

Delta 3 carene

13466-78-9

SCI2, H315

-

 ECHA C&L inventory - self classification

Myrcene beta

123-35-3

SCI2, H315

EDI2, H319

 ECHA C&L inventory - self classification

Camphene

79-92-5

-

EDI2, H319

 ECHA C&L inventory - self classification

Limonene

138-86-3

SCI2, H315

-

 ECHA C&L inventory - Harmonized Classification




Justification for classification or non-classification

Harmonized classification:

Pine needle 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, Pine needle 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).

Based on the typical composition provided by the Lead Registrant, Pine needle 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)

No information was available regarding respiratory irritation.