Registration Dossier

Administrative data

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

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

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
679 mg/kg bw
Based on:
test mat.

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.

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

Applicant's summary and conclusion

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