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Classification & Labelling & PBT assessment

GHS

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General Information

Implementation:
EU
Remarks:
Annex VI, CLP Reg - CAS #: 8050-09-7
Remarks: No evidence of a sensitization response was observed in the key study, a guideline Local Lymph Node Assay conducted in mice, or in ten supporting studies conducted in guinea pigs according to the GPMT or Buehler methods. Gum Rosin is not classified for dermal sensitization according to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Gum Rosin is currently classified for Skin Sensitization according to Annex I to Directive 67/548/EEC as R43: May cause sensitization by skin contact. Gum Rosin is also classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. As part of the harmonized translation between Directive 67/548/EEC and EU CLP Regulation (EC) No. 1272/2008, Table 3.1 of EU CLP Regulation (EC) No. 1272/2008 classifies Gum Rosin as “Skin Sensitizer Category 1” and assigns the hazard statement H317: May cause an allergic skin reaction. Table 3.2 of EU CLP Regulation (EC) No. 1272/2008 contains a list of harmonized classifications and labelling of hazardous substances from Annex I to Directive 67/548/EEC. Gum Rosin is assigned the risk phrase R43: May cause sensitization by skin contact in Table 3.2.

Subsequent evaluation determined that the single positive study for Gum Rosin was actually conducted with an oxidized form of the test material. Several esters of Rosin have been tested using similar protocols with similar results. When the Rosin esters were heated beyond the specified protocol, the oxidized material caused a positive sensitization response. When those same esters were retested using a different protocol which did not cause oxidation, all sensitization responses were negative. While the oxidized form of Gum Rosin should be considered a skin sensitizer, the recommendation is made to declassify non-oxidized Gum Rosin (CAS # 8050-09-7).

Related composition

Related composition:
Composition 59

Classificationopen allclose all

Explosives
Reason for no classification:
conclusive but not sufficient for classification
Flammable gases and chemically unstable gases
Reason for no classification:
conclusive but not sufficient for classification
Aerosols
Reason for no classification:
conclusive but not sufficient for classification
Oxidising gases
Reason for no classification:
conclusive but not sufficient for classification
Gases under pressure
Reason for no classification:
conclusive but not sufficient for classification
Flammable liquids
Reason for no classification:
conclusive but not sufficient for classification
Flammable solids
Reason for no classification:
conclusive but not sufficient for classification
Self-reactive substances and mixtures
Reason for no classification:
conclusive but not sufficient for classification
Pyrophoric liquids
Reason for no classification:
conclusive but not sufficient for classification
Pyrophoric solids
Reason for no classification:
conclusive but not sufficient for classification
Self-heating substances and mixtures
Reason for no classification:
conclusive but not sufficient for classification
Substances and mixtures which in contact with water emit flammable gases
Reason for no classification:
conclusive but not sufficient for classification
Oxidising liquids
Reason for no classification:
conclusive but not sufficient for classification
Oxidising solids
Reason for no classification:
conclusive but not sufficient for classification
Organic peroxides
Reason for no classification:
conclusive but not sufficient for classification
Corrosive to metals
Reason for no classification:
conclusive but not sufficient for classification
Desensitized explosives
Reason for no classification:
data lacking
Acute toxicity - oral
Reason for no classification:
conclusive but not sufficient for classification
Acute toxicity - dermal
Reason for no classification:
conclusive but not sufficient for classification
Acute toxicity - inhalation
Reason for no classification:
conclusive but not sufficient for classification
Skin corrosion / irritation
Reason for no classification:
conclusive but not sufficient for classification
Serious eye damage / eye irritation
Reason for no classification:
conclusive but not sufficient for classification
Respiratory sensitisation
Reason for no classification:
conclusive but not sufficient for classification
Skin sensitisation
Hazard category:
Skin Sens. 1
Hazard statement:
H317: May cause an allergic skin reaction.
Aspiration hazard
Reason for no classification:
conclusive but not sufficient for classification
Reproductive toxicity
Reason for no classification:
conclusive but not sufficient for classification
Effects on or via lactation
Reason for no classification:
conclusive but not sufficient for classification
Germ cell mutagenicity
Reason for no classification:
conclusive but not sufficient for classification
Carcinogenicity
Reason for no classification:
conclusive but not sufficient for classification
1. Specific target organ toxicity - single
Reason for no classification:
conclusive but not sufficient for classification
1. Specific target organ toxicity - repeated
Reason for no classification:
conclusive but not sufficient for classification
Hazardous to the aquatic environment (acute / short-term)
Reason for no classification:
conclusive but not sufficient for classification
Hazardous to the aquatic environment (long-term)
Reason for no classification:
conclusive but not sufficient for classification
Hazardous to the ozone layer
Reason for no classification:
conclusive but not sufficient for classification

Labelling

Signal word:
Warning

Hazard pictogram

GHS07: exclamation mark

Hazard statements

H317: May cause an allergic skin reaction.

Precautionary statements

P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P302+P352: IF ON SKIN: Wash with plenty of water/…
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... …in accordance with local/regional/national /international regulations (to be specified). Manufacturer/supplier or the competent authority to specify whether disposal requirements apply to contents, container or both.
(hazardous waste bin)

Notes