Myrtus communis, ext.

Endpoint summary

Description of key information

- Skin irritation/corrosion: irritating, based on available data and additivity principles.
 - Eye irritation: not irritating (OECD 437, GLP, K, Rel.1)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 March 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well conducted and well described study in accordance with GLP and OECD Guideline 437 without any deviation.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Species:

other: Bovine eyes

Details on test animals or tissues and environmental conditions:

Not applicable

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): Undiluted

Duration of treatment / exposure:

- The undiluted test item was applied in BCOP chamber for 10 minutes followed by an incubation period of 120 ± 10 minutes.

Observation period (in vivo):

- The condition of the cornea was visually assessed immediately after rinsing and at the final opacity measurement.

Number of animals or in vitro replicates:

Not applicable

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period the test item and control items were removed from the anterior chamber and the cornea was rinsed three times with fresh complete minimum essential medium (MEM) containing phenol red before a final rinse with complete MEM. The anterior chamber was refilled with fresh complete MEM.

EVALUATION OF RESULTS:
- Results from the two test method endpoints, opacity and permeability, were combined in an empirically derived formula to generate an in vitro irritancy score.
- The following formula was used to determine the in vitro irritancy score:
In Vitro Irritancy Score = mean opacity value + (15 x mean OD492 value)
Additionally, the opacity and permeability values were evaluated independently to determine whether the test item induced a response through only one of the two endpoints.

Irritation parameter:

other: In vitro irritancy score for negative control

Basis:

mean

Remarks:

3 corneas

Score:

2.5

Reversibility:

other: not applicable

Irritation parameter:

other: In vitro irritancy score for test item

Basis:

mean

Remarks:

3 corneas

Score:

3

Reversibility:

other: not applicable

Irritation parameter:

other: In vitro irritancy score for positive control

Basis:

mean

Remarks:

3 corneas

Score:

45.1

Reversibility:

other: not applicable

Irritant / corrosive response data:

Corneal epithelium condition: The corneas treated with the test item were clear post treatment and post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.

Other effects:

None

See the attached document for tables of results

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, Myrtle oil is considered not to be an ocular corrosive or severe irritant. According to the last revision of the OECD Guideline 437 (26 July 2013), with an IVIS = 3, Myrtle oil does not require classification for eye irritation.

Executive summary:

In an in vitro eye irritation study conducted according to the OECD Guideline 437 and in compliance with GLP, 3 bovine corneas were applied with 0.75 mL of undiluted Myrtle oil for 10 minutes at 32 ±1 ºC followed by an incubation period of 120 ± 10 minutes at 32 ±1 ºC. Negative and positive control items were tested concurrently. After incubation the BCOP holders were removed from the incubator and a final opacity reading was taken. Each cornea was visually observed. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an in vitro irritancy score.

The corneas treated with the test item were clear post treatment and post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation. The in vitro irritancy score for negative and positive controls were 2.5 and 45.1, respectively and the values were within the respective ranges and therefore the study was considered valid. The in vitro irritancy score for the test item was 3, which is considered not to be an ocular corrosive or severe irritant.

 

Under the test conditions, Myrtle oil is considered not to be an ocular corrosive or severe irritant.

According to the last revision of the OECD Guideline 437 (26 July 2013), with an IVIS = 3, Myrtle oil does not require classification for eye irritation.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion:

The decision logic for classification of mixtures from the ECHA Guidance on the Application of the CLP Criteria (2013) was used to determine the skin irritation/corrosion hazard of Myrtle oil. The decision of classification as skin irritant was based on the following arguments:

1 - Existing animal data from irritation study: Skin irritation was observed in guinea-pigs in an acute dermal toxicity study (Moreno, 1979) at the dose of 5000 mg/kg bw. Dermal reactions noted were slight redness (3/10), moderate redness (7/10), slight edema (4/10) and moderate oedema (6/10) at the site of application. 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 Myrtle oils have more than 10% of their constituents classified as Skin irritant Category 2, therefore according to the Regulation (EC) No 1272/2008, Myrtle oil should be classified as a skin irritant without further testing.

- all Myrtle oils have more than 20% of their constituents classified as Skin irritant - R38 - , therefore according to the Directive 1999/45/EEC, Myrtle oil should be classified as a skin irritant without further testing.

Constituent	Classification according to the Regulation (EC) No. 1272/2008 (CLP)		Classification according to the Directive 67/548/EEC		Source
	Skin irritation	Eye irritation	Skin irritation	Eye irritation
Pinene	SCI2, H315	-	Xi ; R38	-	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
Terpineol	SCI2, H315	EDI2, H319	Xi ; R38	Xi ; R36	http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d944137-bb01-5d50-e044-00144f67d249/DISS-9d944137-bb01-5d50-e044-00144f67d249_DISS-9d944137-bb01-5d50-e044-00144f67d249.html
Linalool	SCI2, H315	EDI2, H319	Xi ; R38	-	http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d93c699-8de9-6b59-e044-00144f67d249/DISS-9d93c699-8de9-6b59-e044-00144f67d249_DISS-9d93c699-8de9-6b59-e044-00144f67d249.html

Source: ECHA disseminated dossiers

Eye irritation:

A key study was identified (Warren, 2013, Rel.1). In this BCOP assay conducted according to the OECD Guideline 437 and in compliance with GLP, the in vitro irritancy score for the test item was 3.

According to the last revision of the OECD Guideline 437 (26 July 2013), with an IVIS = 3, Myrtle oil does not require classification for eye irritation.

Justification for selection of skin irritation / corrosion endpoint:
Available data indicates that the criteria are met for classification as irritating to the skin

Justification for selection of eye irritation endpoint:
Only one study available. The key study is GLP-compliant and of high quality (Klimisch score = 1).

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Harmonized classification:

Myrtle 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, Myrtle oil is classified as skin irritant:

- Irritating to skin (Xi; R38) according to the criteria of the Directive 1999/45/EEC,

- 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, Myrtle oil is not classified as eye irritant according to the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EEC.

No information was available regarding respiratory irritation.