Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
1272/2008 CLP Henkel Registration (AOT 3, H301; AIT 2, H330; Skin Sens. 1A, H317; Eye Dam. 1, H318; Resp. Sens 1, H334; STOT SE3, H335; H400 Ma=1; H410 Mc=10); SPEC; AM <= 100%
Implementation:
EU
Remarks:

HENKEL REGISTERED SUBSTANCE

 

CS 157799; SPEC -

Data Tox, Reference:

- C&L based on study results;

- Resp. sensitisation based on EJ (ASS 1800110 -1):

The unique feature common to all isocyanates is that they contain N=C=O (isocyanate) functional groups attached to an aromatic or aliphatic parent compound. Isocyanates can cause skin sensitization, asthma, skin or mucous membrane irritation, and, rarely hypersensitivity pneumonitis. However, the most common adverse health outcome associated with isocyanate exposure is asthma due to sensitization.

 

Evidence exists that respiratory sensitization is triggered by dermal induction. In addition, vice versa, topical contact hypersensitivity was observed after previous induction by inhalation. The Technical Guidance Document (TGD) on information requirements for REACH (R.7a; page 256ff) proposes that, in the absence of specific health effects data, only diisocyanates that also meet the criteria for classification for skin sensitization are presumed to be respiratory sensitizers. It is assumed that this recommendation also applies to monoisocyanates such as 3,4-dichlorophenyl isocyanate. 3,4-Dichlorophenyl isocyanate is a strong skin sensitizer in the Magnusson & Kligman Test. It is therefore concluded that 3,4-dichlorophenyl isocyanate is contributing to the development of isocyanate asthma, presumably by inducing systemic sensitization.

 

According to the recent background document to the opinion on the Annex XV dossier proposing restrictions on diisocyanates (https://echa.europa.eu/documents/10162/ddc6108d-a33e-3087-6a6a-8754783c2aa8) RAC considers that for monoisocyanates, based on indirect evidence from humans and animals referenced in that document, the risk of respiratory sensitization in humans cannot be excluded.

 

The German Commission for Investigation of Health Hazards of Chemical Compounds in the Work Area also concluded (see p. 201:https://onlinelibrary.wiley.com/doi/pdf/10.1002/9783527812127.ch4) that sensitizing effects of monoisocyanates on the respiratory tract cannot be ruled out. However, data for the diisocyanates, which are assessed as potent respiratory allergens, would not justify classifying monoisocyanates as substances causing airway sensitization solely in analogy; an evaluation of the individual case is necessary.

 

Information on the individual structural analogues phenyl isocyanate (CAS 103-71-9) and 4-chlorophenyl isocyanate (CAS 104-12-1) support the conclusion that 3,4-dichlorophenyl isocyanate may pose a respiratory health hazard. Workers exposed to phenyl isocyanate showed specific IgE for isocyanate-albumin conjugates. These workers also developed asthmatic symptoms (BG Chemie, Phenylisocyanate Nr. 198, 1997). Furthermore, phenyl isocyanate is classified by German Commission for Investigation of Health Hazards of Chemical Compounds in the Work Area as respiratory sensitizer. 4-Chlorophenyl isocyanate, a close analogue to 3,4-dichlorophenyl isocyanate, is not skin-sensitizing when tested in a split adjuvant test in guinea pigs. However, 4-chlorophenyl isocyanate is classified as respiratory sensitizer according to CLP, Annex VI.

 

Taking all available information into account 3,4-dichlorophenyl isocyanate is classified as respiratory sensitizer in a Weight of Evidence assessment.

Data Eco, Reference:

The environmental classification is based on ecotoxicity data for the hydrolysis product 3,4 -Dichlorophenylamine against freshwater invertebrates. 

Related composition

Related composition:
Composition 1
Composition 2

Classificationopen allclose all

Explosives
Reason for no classification:
conclusive but not sufficient for classification
Flammable gases and chemically unstable gases
Reason for no classification:
data lacking
Aerosols
Reason for no classification:
data lacking
Oxidising gases
Reason for no classification:
data lacking
Gases under pressure
Reason for no classification:
data lacking
Flammable liquids
Reason for no classification:
data lacking
Flammable solids
Reason for no classification:
conclusive but not sufficient for classification
Self-reactive substances and mixtures
Reason for no classification:
data lacking
Pyrophoric liquids
Reason for no classification:
data lacking
Pyrophoric solids
Reason for no classification:
conclusive but not sufficient for classification
Self-heating substances and mixtures
Reason for no classification:
data lacking
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:
data lacking
Oxidising solids
Reason for no classification:
conclusive but not sufficient for classification
Organic peroxides
Reason for no classification:
data lacking
Corrosive to metals
Reason for no classification:
data lacking
Desensitized explosives
Reason for no classification:
data lacking
Acute toxicity - oral
Hazard category:
Acute Tox. 3
Hazard statement:
H301: Toxic if swallowed.
Acute toxicity - dermal
Reason for no classification:
data lacking
Acute toxicity - inhalation
Hazard category:
Acute Tox. 2
Hazard statement:
H330: Fatal if inhaled.
Skin corrosion / irritation
Reason for no classification:
conclusive but not sufficient for classification
Serious eye damage / eye irritation
Hazard category:
Eye Damage 1
Hazard statement:
H318: Causes serious eye damage.
Respiratory sensitisation
Hazard category:
Resp. Sens. 1
Hazard statement:
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
Skin sensitisation
Hazard category:
Skin Sens. 1A
Hazard statement:
H317: May cause an allergic skin reaction.
Aspiration hazard
Reason for no classification:
data lacking
Reproductive toxicity
Reason for no classification:
data lacking
Effects on or via lactation
Reason for no classification:
data lacking
Germ cell mutagenicity
Reason for no classification:
conclusive but not sufficient for classification
Carcinogenicity
Reason for no classification:
data lacking
1. Specific target organ toxicity - single
Hazard category:
STOT Single Exp. 3
Hazard statement:
H335: May cause respiratory irritation.
Affected organs:
resp. tract
Route of exposure:
Inhalation
1. Specific target organ toxicity - repeated
Reason for no classification:
data lacking
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 1
Hazard statement:
H410: Very toxic to aquatic life with long lasting effects.
M-Factor acute:
1
M-Factor chronic:
10
Hazardous to the ozone layer
Reason for no classification:
data lacking

Labelling

Signal word:
Danger

Hazard pictogram

GHS09: environment
GHS05: corrosion
GHS06: skull and crossbones

Hazard statements

H400: Very toxic to aquatic life.
H410: Very toxic to aquatic life with long lasting effects.
H301: Toxic if swallowed.
H317: May cause an allergic skin reaction.
H318: Causes serious eye damage.
H330: Fatal if inhaled.
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
H335: May cause respiratory irritation.

Notes