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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

- Skin irritation/corrosion: irritating, based on available data and additivity principles.
- Eye irritation/corrosion: not irritating, BCOP test negative and classified constituents for eye irritation, below 10% of the total composition.

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 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

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

  Terpineol-4

  562-74-3

  SCI2, 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:
1975
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
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:
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 data
Irritation parameter:
other:
Remarks on result:
not determinable because of methodological limitations
Irritant / corrosive response data:
- Mortality was observed in 2/10 animals (first animal died on Day 4 and second animal died on Day 13).
- Slight and moderate redness were observed in 2/10 and 7/10 animals, respectively.
- Moderate oedema was observed in 9/10 animals.
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, Cypress oil induced slight to moderate skin irritation in rabbits.
Executive summary:

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

Mortality was observed in 2/10 animals. Slight and moderate redness were observed in 2/10 and 7/10 animals respectively. Moderate oedema was observed in 9/10 animals. No other clinical signs were observed.

Under the test conditions, Cypress 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 on the classification based solely on this study.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 January 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
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)
Remarks:
UK GLP Compliance Programme (inspected on 10 July 2012/ signed on 30 November 2012)
Species:
other: bovine eye
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST SYSTEM
- Eyes from adult cattle were obtained from a local abattoir as a by-product from freshly slaughtered animals. The eyes were excised and placed in Hanks' Balanced Salt Solution (HBSS), supplemented with Penicillin/Streptomycin, and transported to the laboratory on ice packs. The corneas were prepared immediately on arrival.
Vehicle:
unchanged (no vehicle)
Controls:
other: negative control: 0.9 % w/v sodium chloride solution
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL was applied on each cornea
- Concentration: Test material: undiluted; negative control: 0.9 % w/v sodium chloride solution; positive control: ethanol
Duration of treatment / exposure:
The undiluted test item was applied for 10 minutes at 32 ± 1 °C followed by an incubation period of 120 ± 10 minutes at 32 ± 1 °C.
Observation period (in vivo):
- Corneal opacity was measured before and after 120 ± 10 minutes of incubation.
- Application of Sodium Fluorescein (4 mg/mL) and corneal permeability was measured after 90 min of incubation at 32 ± 1 °C.
Number of animals or in vitro replicates:
Total: 9 corneas - 3 corneas/group for test item, negative and positive controls
Details on study design:
Details of test procedure: Corneas obtained from freshly slaughtered adult cattle (from a local abattoir) were mounted in corneal holders. Both chambers of each BCOP holder were filled with complete MEM culture media (MEM) and incubated for 60 minutes at 32 ± 1 °C. Before the treatment, opacity measurement was performed using an opacitometer. The test item (0.75 mL) was applied on each cornea for 10 minutes at 32 ± 1 °C. 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 MEM containing phenol red before a final rinse with complete MEM. The anterior chamber was refilled with fresh complete MEM. A post-treatment opacity reading was taken and each cornea was visually observed. The holders were incubated, anterior chamber facing forward, at 32 ± 1 °C for 120 ± 10 minutes. After incubation the holders were removed from the incubator and a final opacity reading was taken. Each cornea was visually observed. Following the opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (4 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ± 1 °C for 90 minutes. After incubation the medium in the posterior chamber of each holder was decanted and retained. 360 µL of medium representing each cornea was applied to a designated well on a 96-well plate and the optical density at 492 nm (OD492) was measured.
Irritation parameter:
in vitro irritation score
Run / experiment:
120 min
Value:
5.3
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

See the attached document for information on tables of results

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, Cypress oil, induced an IVIS of 5.3 and is not classified as corrosive or severe irritant for the isolated bovine cornea.
Executive summary:

In an in vitro eye irritation study performed according to the OECD Guideline 437 and in compliance with GLP, 0.75 mL of Cypress oil was applied to isolated bovine corneas mounted in corneal holders, and incubated for 120 ± 10 minutes at 32 ± 1 °C using the closed chamber method. Three corneas were used for each treated series (undiluted test item; negative control; positive control: ethanol). Before the treatment, a first opacity measurement was performed using an opacitometer. 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 (IVIS).

 

The test item, negative and positive control induced an IVIS of 5.3, 0.3 and 50.5, respectively. The corneas treated with the negative control and test item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation. The positive control In Vitro Irritancy Score was within the range of 30.9 to 67.7, therefore the acceptance criterion was satisfied.

Under the test conditions, Cypress oil induced an IVIS of 5.3. Cypress oil is therefore not classified as as an ocular corrosive or severe irritant for the eyes.

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: Not classified
Interpretation of results:
GHS criteria not met
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 no more than 10% of its constituents classified as Eye irritant Category 2 and should not be classified as a Eye irritant Category 2 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

Delta 3 carene

13466-78-9

NC

 ECHA C&L inventory - self classification

Myrcene beta

123-35-3

Eye.Irrit.2, H319

 ECHA C&L inventory - self classification

Limonene

138-86-3

NC

 ECHA C&L inventory - Harmonized Classification

  Cedrol

  77 -53 -2

NC  

   ECHA C&L inventory - self classification

Source: ECHA disseminated dossiersor self classification

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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 Cypress 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, 1975) at the dose of 5000 mg/kg bw. Dermal reactions noted were slight and moderate redness in 2/10 and 7/10 animals, respectively. Moderate oedema was observed in 9/10 animals. 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.Hawever, based on these data, the test substance is considered as not corrosive to skin.

2/ Existing data on constituents (additivity principles):

- all Cypress 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 and to the GHS.

Eye irritation:

Cypress oil has been tested in vitro regarding its potential as severe occular irritant or corrosive according to the OECD guildeline No. 437 (BCOP test). The test item, negative and positive control induced an IVIS of 5.3, 0.3 and 50.5, respectively. As the IVIS obtained with Cypress oil is lower than 55.1, Cypress oil is not considered as a severe ocular irritant or corrosive.

Moreover Cypress oil is not classified for eye irritation by the IFRA Labelling manual (2013) and no more than 10% of the composition is classified as Eye irrit. cat. 2 (H319) according to the Regulation (EC) No. 1272/2008 and to the GHS.

Therefore Cypress oil is not considered as eye irritating.

 



Justification for classification or non-classification

Harmonized classification:

Cypress 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, Cypress 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 results obtained in the BCOP assay and based on the typical concentration provided by the Lead registrant, Cypress oil is not classified as eye irritant according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

No information was available regarding respiratory irritation