Juniper, Juniperus communis, ext.

Endpoint summary

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

Reference

Reference 1

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 (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 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
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
Terpineol-4	562-74-3	SCI2, H315	ECHA C&L inventory - self classification

Source: ECHA disseminated dossiers or self classification

Reference 2

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: Study was conducted according to a non-standard method and documentation was insufficient for assessment.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

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 or test system and environmental conditions:

No data

Type of coverage:

not specified

Preparation of test site:

other: intact and abraded

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 (3 intact skin and 3 abraded skin animals)

Irritation parameter:

other:

Basis:

other:

Remarks:

In an acute dermal toxicity study (limit test)

Time point:

14 d

Remarks on result:

other: Moderate erythema followed by drying, cracking, and shedding of the skin was observed.

Irritant / corrosive response data:

- Moderate erythema followed by drying, cracking, and shedding of the skin was observed.

Other effects:

- One animal with abraded skin was died on Day 6.

None

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the test conditions, Juniper Berry Oil induced moderate skin irritation in rabbits.

Executive summary:

In an acute dermal toxicity study (limit test), six albino rabbits (three with intact skin and three with abraded skin) were given a single dermal application of Juniper Berry Oil at 5000 mg/kg bw. Animals were observed for mortality, clinical signs and local reactions daily for 14 days.

 

One animal with abraded skin was died on Day 6. No animal with intact skin died. Moderate erythema followed by drying, cracking, and shedding of the skin was observed. In this study, the acute dermal LD50 of Juniper Berry Oil was higher than 5000 mg/kg bw in albino rabbits.

 

Under the test conditions, juniper berry oil 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)
		Eye irritation	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
Myrcene beta	123-35-3	EDI2, H319	ECHA C&L inventory - self classification
Limonene	138-86-3	NC	ECHA C&L inventory - Harmonized Classification
Terpineol-4	562-74-3	NC	ECHA C&L inventory - self classification
Camphene	79-92-5	EDI2, H319	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 Juniper 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. Moderate erythema followed by drying, cracking, and shedding of the skin was observed

Adequate scoring of skin effects was not provided, therefore it was not possible to take a decision of 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 Juniper 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:

Juniper 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 Juniper 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 number	Classification according to the Regulation (EC) No. 1272/2008 (CLP)		Source
		Skin Irritation	Eye Irritation
Pinene alpha	80-56-8	SCI2, H315	-	http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d952924-c8ed-4614-e044-00144f67d249/DISS-9d952924-c8ed-4614-e044-00144f67d249_DISS-9d952924-c8ed-4614-e044-00144f67d249.html IFRA Labelling manual (2013)
Pinene Beta	127-91-3	SCI2, H315	-	http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d85bc06-0d47-6e67-e044-00144f67d249/DISS-9d85bc06-0d47-6e67-e044-00144f67d249_DISS-9d85bc06-0d47-6e67-e044-00144f67d249.html IFRA Labelling manual (2013)
Myrcene beta	123-35-3	SCI2, H315	EDI2, H319	http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d82fafa-8716-3e64-e044-00144f67d249/DISS-9d82fafa-8716-3e64-e044-00144f67d249_DISS-9d82fafa-8716-3e64-e044-00144f67d249.html IFRA Labelling manual (2013)
Camphene	79-92-5	-	EDI2, H319	http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d953a2a-5979-54ee-e044-00144f67d249/DISS-9d953a2a-5979-54ee-e044-00144f67d249_DISS-9d953a2a-5979-54ee-e044-00144f67d249.html IFRA Labelling manual (2013)
Limonene	138-86-3	SCI2, H315	-	http://apps.echa.europa.eu/registered/data/dossiers/DISS-9eb16d5d-b83e-2831-e044-00144f67d031/DISS-9eb16d5d-b83e-2831-e044-00144f67d031_DISS-9eb16d5d-b83e-2831-e044-00144f67d031.html IFRA Labelling manual (2013)
Terpineol-4	562-74-3	SCI2, H315	-	IFRA Labelling manual (2013)

Justification for classification or non-classification

Harmonized classification:

Juniper 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, Juniper 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 GHS.

- Based on the typical composition provided by the Lead Registrant, Juniper oil is also classified as eye irrit. cat. 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.