Essential oil of Platycladus orientalis (L.) Franco obtained from branches and leaves by steam distillation followed by vacuum distillation

Endpoint summary

Description of key information

Based on CLP regulation an ATE for oral toxicity was calculated at 679 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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

Principles of method if other than guideline:

Classification based on calculation rules for mixtures of the CLP Regulation

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

679 mg/kg bw

Based on:

test mat.

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 acute oral toxicity hazard of the registered substance.

A DL50 or an ATE estimate can be derived based on the current classification for a part of these constituents.

Data on constituents:

Constituent	CAS	DL50/ ATE estimates	Sources
Fenchone	1195-79-5	4400 mg/kg (DL50)	Synthesis and Herbicidal Activity of Modified Monoterpenes Structurally Similar to Cinmethylin, Steven F. Vaughn and Gayland F. Spencer, Weed Science, Vol. 44, No. 1, pp. 7-11, (Jan. - Mar., 1996).
sabinene	3387-41-5	Not classified	C&L inventory
Beta- thujone	1125-12-8	192 mg/kg (DL50)	EMA/HMPC/732886/2010
Bornyl acetate	5655-61-8	Not classified	C&L inventory
Alpha-pinene	80-56-8	Acute tox cat 4	C&L inventory
limonene	138-86-3	Not classified	C&L inventory
Terpineol-4	562-74-3	Acute tox cat 4 DL50=1300 mg/kg	C&L inventory HSDB [Lewis, R.J. Sr. (ed) Sax's Dangerous Properties of Industrial Materials. 11th Edition. Wiley-Interscience, Wiley & Sons, Inc. Hoboken, NJ. 2004., p. 3363]
Gamma-terpinene	99-85-4	Not classified	C&L inventory
Beta-myrcene	123-35-3	Not classified	C&L inventory
Beta-pinene	127-91-3	Not classified  >5000 mg/kg	C&L inventory CORAP report
Alpha-thujene	2867-05-2	Not classified	C&L inventory
camphene	79-92-5	Not classified	C&L inventory
p-cymene	99-87-6	100 mg/kg	CLH proposals
p-mentha-1,3-diene	99-86-5	LD 50: 1680 mg/kg bw/day	CLH report  (Anonymous 1973); EFSA (2015) ; (JECFA 2004);
Alpha terpinyl acetate	80-26-2	Not classified	C&L inventory
Alpha fenchene	471-84-1	Not classified	C&L inventory
Alpha-thujone	546-80-5	192 mg/kg (DL50)	EMA/HMPC/732886/2010
Alpha-terpinolene	586-62-9	Not classified	C&L inventory
Alpha elemol	639-99-6	Not classified	C&L inventory
Alpha-phellandrene	99-83-2	Not classified	C&L inventory
Beta-phellandrene	555-10-2	Not classified	C&L inventory
Beta-caryophylene	87-44-5	Not classified	C&L inventory
camphor	76-22-2	500 mg/kg	C&L inventory
borneol	208-080-0	Acute tox cat 4 or not classified	C&L inventory
Alpha-humulene	6753-98-6	Not classified	C&L inventory
Alpha-terpineol	98-55-5	Not classified	C&L inventory
Delta-3-carene	13466-78-9	3956 mg/kg	CORAP report sur Beta-pinene
linalol	78-70-6	Not classified	C&L inventory
Fenchyl acetate	13851-11-1	Not classified	C&L inventory
Sabinyl acetate	3536-54-7		No data
Delta-cadiene	483-76-1		No data
Gamma-cadiene	1460-97-5		No data
beyerene	3564-54-3		No data

  For Substances not classified according to the CLP Regulation an ATE estimates of 2001 has been considered.

See full study report for detailled calculation

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The ATE calculated lead to a classification as Acute oral toxicity category 4.

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 acute oral toxicity hazard of the registered substance. The decision of classification as Category 4 was based on existing data on constituents (additivity principles):the registered substance has an ATE mixture estimated at 679mg/kg and should be classified as a Acute toxicity category 4 without further testing according to the rules for classification of mixtures of Regulation (EC) No 1272/2008

Endpoint conclusion

Dose descriptor:

LD50

Value:

679 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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 acute oral toxicity hazard of the registered substance. The decision of classification as Category 4 was based on existing data on constituents (additivity principles):the registered substance has an ATE mixture estimated at 679 mg/kg and should be classified as a Acute toxicity category 4

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

Justification for classification or non-classification

Harmonized classification:

The registered substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the available information and composition provided by the Lead Registrant, the registered substance is classified as acute oral toxicty Category 4 (H302: harmfull if swallowed.) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP).