Essential oil camphor-rich of Artemisia herba-alba (Asteraceae) obtained from herb by steam distillation

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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

Data source

Reference

Reference Type:

other: Guidance

Title:

Guidance on the Application of the CLP Criteria - Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures

Author:

ECHA

Year:

2017

Bibliographic source:

ECHA-17-G-21-EN

Materials and methods

Principles of method if other than guideline:

Classification based on calculation rules for mixtures of the CLP Regulation

Test material

Test material information

Constituent 1

Reference substance name:

Essential oil camphor-rich of Artemisia herba-alba (Asteraceae) obtained from herb by steam distillation

Molecular formula:

not relevant for a UVCB substance

IUPAC Name:

Essential oil camphor-rich of Artemisia herba-alba (Asteraceae) obtained from herb by steam distillation

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

329.12 mg/kg bw

Based on:

not specified

Any other information on results incl. tables

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.

According to CLP Regulation (1272/2008/CE): the ‘relevant ingredients’ of a mixture are those which are present in concentrations of 1 % or greater.

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

Constituent	CAS	DL50/ ATE estimates	Sources
Alpha-thujone	546-80-5	192 mg/kg (DL50)	EMA/HMPC/732886/2010
Beta- thujone	1125-12-8	192 mg/kg (DL50)	EMA/HMPC/732886/2010
camphor	76-22-2	500mg/kg	C&L inventory
camphene	79-92-5	Not classified	C&L inventory
1,8-cineole	470-82-6	Not classified	C&L inventory
L-borneol	464-45-9	Not classified	C&L inventory
terpineol-4	562-74-3	500mg/kg	C&L inventory
alpha-terpinene	99-86-5	500mg/kg	CLH proposals
Cuminic aldehide	122-03-2	500mg/kg	CLH proposals
p-cymene	99-87-6	100 mg/kg	CLH proposals
Myrtenol	515-00-4	500mg/kg	C&L inventory

Application of the additivity approach :

According to CLP regulation point 3.1.3.6.1 : The ATE of the mixture is determined by calculation from the ATE values for all relevant ingredients.

The ATE calculated is 329.12 mg/kg

For detailled calculation see attached background material

Applicant's summary and conclusion

Interpretation of results:

Category 4 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 acute oral toxicity hazard of the registered substance. The decision of classification as Category 3 was based on existing data on constituents (additivity principles): the registered substance has an ATE mixture estimated at 329.12mg/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