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

Endpoint summary

Description of key information

Based on CLP regulation an ATE for oral toxicity was calculated at 329.1 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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:

329.12 mg/kg bw

Based on:

not specified

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

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

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

discriminating dose

Value:

329.12 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 3 was based on existing data on constituents (additivity principles):the registered substance has an ATE mixture estimated at 329.12 mg/kg and should be classified as a Acute toxicity category 3 without further testingaccording 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).