Registration Dossier

Administrative data

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).