Registration Dossier

Classification & Labelling & PBT assessment

GHS

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General Information

Implementation:
EU
Remarks:

Self-classification.

Signal word "Danger" and hazard statement "H304: May be fatal if swallowed and enters airways" are required according to the data available, being the substance classified for Aspiration Hazard Category 1 according to CLP Regulation (EC) nº 1272/2008.

In two GLP studies performed with d-limonene according to OECD guideline 404, the maximum score obtained for erythema and edema was 2. According to CLP Regulation (EC) n° 1272/2008, the major criterion for the irritant category is that at least 2 of 3 tested animals have a mean score of ≥ 2.3; therefore, l-limonene (by read-across) should not be classified for skin irritation according to CLP Regulation (EC) n° 1272/2008. l-limonene is currently classified for skin irritation "H315: Causes skin irritation." according to Annex VI of CLP Regulation (EC) n° 1272/2008. This classification is not supported by the data submitted in the registration dossier. The recommendation is made to declassify l-limonene for skin irritation.

The substance is classified for Skin sensitization Category 1 according to Annex VI of CLP Regulation (EC) nº 1272/2008. Based on available experimental (OECD 429) data where an EC3 of 68.3% was obtained, the substance should be classified as Skin sensitizer Category 1B, since the EC3 value is higher than 2%.

The substance is classified as Aquatic Acute Cat. 1 based on the acute toxicity data (EC50 < 1 mg/L). This classification is in accordance to the harmonized classification (Annex VI of CLP Regulation (EC) n° 1272/2008). However, the available chronic toxicity data lead to a classification in Aquatic Chronic 3 (NOEC between 0.1 and 1 mg/L, ready biodegradable substance) which is not in accordance with the current harmonized classification in the Annex VI of CLP Regulation (EC) n° 1272/2008 (i.e. Aquatic Chronic 1). The Hazard statement "H410: Very toxic to aquatic life with long lasting effects" should be replaced by "H412: Harmful to aquatic life with long lasting effects".

Related composition

Related composition:
Composition 1
Composition 3

Classificationopen allclose all

Explosives
Reason for no classification:
data conclusive but not sufficient for classification
Flammable gases and chemically unstable gases
Reason for no classification:
data conclusive but not sufficient for classification
Aerosols
Reason for no classification:
data conclusive but not sufficient for classification
Oxidising gases
Reason for no classification:
data conclusive but not sufficient for classification
Gases under pressure
Reason for no classification:
data conclusive but not sufficient for classification
Flammable liquids
Hazard category:
Flam. Liquid 3
Hazard statement:
H226: Flammable liquid and vapour.
Flammable solids
Reason for no classification:
data conclusive but not sufficient for classification
Self-reactive substances and mixtures
Reason for no classification:
data conclusive but not sufficient for classification
Pyrophoric liquids
Reason for no classification:
data conclusive but not sufficient for classification
Pyrophoric solids
Reason for no classification:
data conclusive but not sufficient for classification
Self-heating substances and mixtures
Reason for no classification:
data conclusive but not sufficient for classification
Substances and mixtures which in contact with water emit flammable gases
Reason for no classification:
data conclusive but not sufficient for classification
Oxidising liquids
Reason for no classification:
data conclusive but not sufficient for classification
Oxidising solids
Reason for no classification:
data conclusive but not sufficient for classification
Organic peroxides
Reason for no classification:
data conclusive but not sufficient for classification
Corrosive to metals
Reason for no classification:
data conclusive but not sufficient for classification
Desensitized explosives
Reason for no classification:
data lacking
Acute toxicity - oral
Reason for no classification:
data conclusive but not sufficient for classification
Acute toxicity - dermal
Reason for no classification:
data conclusive but not sufficient for classification
Acute toxicity - inhalation
Reason for no classification:
data conclusive but not sufficient for classification
Skin corrosion / irritation
Reason for no classification:
data conclusive but not sufficient for classification
Serious eye damage / eye irritation
Reason for no classification:
data conclusive but not sufficient for classification
Respiratory sensitisation
Reason for no classification:
data lacking
Skin sensitisation
Hazard category:
Skin Sens. 1B
Hazard statement:
H317: May cause an allergic skin reaction.
Aspiration hazard
Hazard category:
Asp. Tox. 1
Hazard statement:
H304: May be fatal if swallowed and enters airways.
Reproductive toxicity
Reason for no classification:
data conclusive but not sufficient for classification
Effects on or via lactation
Reason for no classification:
data lacking
Germ cell mutagenicity
Reason for no classification:
data conclusive but not sufficient for classification
Carcinogenicity
Reason for no classification:
data conclusive but not sufficient for classification
1. Specific target organ toxicity - single
Reason for no classification:
data conclusive but not sufficient for classification
1. Specific target organ toxicity - repeated
Reason for no classification:
data conclusive but not sufficient for classification
Hazardous to the aquatic environment (acute / short-term)
Hazard category:
Aquatic Acute 1
Hazard statement:
H400: Very toxic to aquatic life.
Hazardous to the aquatic environment (long-term)
Hazard category:
Aquatic Chronic 3
Hazard statement:
H412: Harmful to aquatic life with long lasting effects.
M-Factor chronic:
1
Hazardous to the ozone layer
Reason for no classification:
data conclusive but not sufficient for classification

Labelling

Signal word:
Danger

Hazard pictogram

GHS02: flame
GHS07: exclamation mark
GHS08: health hazard
GHS09: environment

Hazard statements

H226: Flammable liquid and vapour.
H317: May cause an allergic skin reaction.
H304: May be fatal if swallowed and enters airways.
H410: Very toxic to aquatic life with long lasting effects.

Precautionary statements

P273: Avoid release to the environment.
P280: Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...
P301+P310: IF SWALLOWED: Immediately call a POISON CENTER/doctor/…
P331: Do NOT induce vomiting.
P302+P352: IF ON SKIN: Wash with plenty of water/…
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P501: Dispose of contents/container to ...

Notes

Note C