Brief Profile

The Brief Profile summarizes the non-confidential data on substances as it is held in the databases of the European Chemicals Agency (ECHA), including data provided by third parties. The Brief Profile is automatically generated; note that it does not currently distinguish between harmonised classification and minimum classification; information requirements under different legislative frameworks may therefore not be fully up to date or complete. For accuracy reasons, substance manufacturers and imports have the responsibility to consult official sources, e.g. the electronic edition of the Official Journal of the European Union.
This Brief Profile is covered by the ECHA Legal Notice.

Substance Description

Substance identity

  • EC / List name: Melaleuca alternifolia, ext.
  • IUPAC name:
  • Other names
EC / List no.:
285-377-1
CAS no.:
85085-48-9
Index number:
Molecular formula:
SMILES:
InChI:
Type of substance:
UVCB
Origin:
Other
Registered compositions:
20
Of which contain:
0 impurities relevant for classification
0 additives relevant for classification
Substance Listed:
EINECS (European INventory of Existing Commercial chemical Substances) List

Hazard classification & labelling

Danger! According to the classification provided by companies to ECHA in REACH registrations this substance may be fatal if swallowed and enters airways, is toxic to aquatic life with long lasting effects, is a flammable liquid and vapour, is harmful if swallowed, is harmful if inhaled, causes skin irritation and may cause an allergic skin reaction.

Additionally, the classification provided by companies to ECHA in CLP notifications identifies that this substance causes serious eye irritation.

Breakdown of all 1125 C&L notifications submitted to ECHA

Acute Tox. 4 H302
Asp. Tox. 1 H304
Skin Irrit. 2 H315
Skin Sens. 1 H317
Aquatic Chronic 2 H411
Flam. Liq. 3 H226
Eye Irrit. 2 H319
Not Classified
Acute Tox. 4 H332
Acute Tox. 4 H312
Eye Dam. 1 H319
STOT SE 3 H335
STOT SE 3 H336
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

https://echa.europa.eu/diss-blank-theme/images/cnl/graph/tick.png Harmonised Classification

https://echa.europa.eu/diss-blank-theme/images/cnl/graph/Reach.png REACH registration dossiers notifications

https://echa.europa.eu/diss-blank-theme/images/cnl/graph/CLP.png CLP notifications

Properties of concern

  • Ss

Regulatory activities

Registration, Evaluation, Authorisation & Restriction of Chemicals (REACH)

Registration
Pre-registration:
Substance pre-registered under REACH.
Registration:
This substance has 31 active registrations under REACH, 1 Joint Submission(s) and 0 Individual Submission(s).
Please see Registrants/Suppliers details.
Evaluation
Dossier Evaluation:
Substance Evaluation:
Authorisation
Candidate List:
Annex XIV (Authorisation List):
Restriction
Annex XVII (Restriction List):

Classification Labelling & Packaging (CLP)

Harmonised C&L:
Notification:
Classification & Labelling has been notified by industry to ECHA for this substance.

Biocidal Products Regulation (BPR)

Active Substance:
Biocidal Products:

Prior Informed Consent (PIC)

Annex I:
Annex V:

European Union Observatory for Nanomaterials (EUON)

EUON:

About this substance

This substance is manufactured and/or imported in the European Economic Area in 100 - 1 000 tonnes per year.

This substance is used by consumers, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing.

This substance is used in the following products: washing & cleaning products, biocides (e.g. disinfectants, pest control products), polishes and waxes and cosmetics and personal care products.

Other release to the environment of this substance is likely to occur from: indoor use as processing aid.

ECHA has no public registered data on the use of this substance in activities or processes at the workplace.

ECHA has no public registered data on the routes by which this substance is most likely to be released to the environment.

ECHA has no public registered data indicating whether or into which articles the substance might have been processed.

This substance is used in the following products: washing & cleaning products, polishes and waxes and perfumes and fragrances.

ECHA has no public registered data on the types of manufacture using this substance.

This substance is used in the following activities or processes at workplace: transfer of chemicals, roller or brushing applications, non-industrial spraying and closed processes with no likelihood of exposure.

Other release to the environment of this substance is likely to occur from: indoor use (e.g. machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances and air fresheners).

This substance is used in the following products: perfumes and fragrances, cosmetics and personal care products and washing & cleaning products.

This substance is used in the following activities or processes at workplace: transfer of chemicals, closed processes with no likelihood of exposure, closed, continuous processes with occasional controlled exposure, closed batch processing in synthesis or formulation, mixing in open batch processes, transfer of substance into small containers and batch processing in synthesis or formulation with opportunity for exposure.

Release to the environment of this substance can occur from industrial use: formulation of mixtures.

This substance is used in the following products: washing & cleaning products and perfumes and fragrances.

ECHA has no public registered data on the types of manufacture using this substance.

This substance is used in the following activities or processes at workplace: transfer of chemicals, industrial spraying, batch processing in synthesis or formulation with opportunity for exposure, closed, continuous processes with occasional controlled exposure and roller or brushing applications.

Release to the environment of this substance can occur from industrial use: in processing aids at industrial sites.

This substance is used in the following activities or processes at workplace: closed processes with no likelihood of exposure, transfer of chemicals at dedicated facilities, closed, continuous processes with occasional controlled exposure, mixing in open batch processes and laboratory work.

Release to the environment of this substance can occur from industrial use: manufacturing of the substance.

Precautions for using this substance have been recommended by its registrants under REACH, as follows:

Prevention statements

When handling this substance: ground and bond container and receiving equipment; take actions to prevent static discharges; keep away from heat, sparks, open flames and/or hot surfaces – No smoking; use only outdoors or in a well-ventilated area; keep container tightly closed; do not eat, drink or smoke when using this product; use explosion-proof equipment (electrical/ventilating/lighting/etc.); use non-sparking tools; wash parts of the body (as specified by manufacturer/supplier)in contact with substance thoroughly after handling; wear protective gloves and/or clothing, and eye and/or face protection as specified by manufacturer/supplier; avoid breathing the dust, fume, gas, mist, vapours or spray.

Response statements

In case of incident: Call a poison center or doctor/physician if you feel unwell. Take off contaminated clothing and wash it before reuse. If swallowed: immediately call a poison center or doctor/physician. If skin irritation occurs: Get medical advice/attention. If on skin (or hair): take off immediately all contaminated clothing. Rinse skin with water or shower. If inhaled: remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of fire: Use (measures specified by manufacturer/supplier) for extinction. Collect spillage. Do not induce vomiting. If swallowed: call a poison center or doctor/physician if you feel unwell. If on skin: wash with soap and water.

Storage statements

Store this substance in a well-ventilated place and Keeping it cool; locked up.

Disposal statements

The substance must be disposed in accordance with local/regional/national/international regulation.

Guidance on the safe use of the substance provided by manufacturers and importers of this substance.

Registrants/suppliers

  • Arrow Regulatory (Ireland) Ltd OR1707, Suite 307, No.9 9 Pembroke Street Upper D02 KR83 Dublin 2 Ireland
  • Augustus Oils Ltd, Augustus House Mill Lane GU34 2QG Alton Hampshire United Kingdom
  • BONTOUX S.A.S., Le clôt 26170 Saint Auban sur l'Ouvèze France
  • CASSEGRAIN ENTREPRISES, 30 Rue Augste Piccard C/ PhytoElan 01630 Saint Genis Pouilly France
  • Claus Nitsche & Sohn GmbH, Billbrookdeich 122 D-22113 Hamburg Germany
  • De Monchy Europe Purchasing Ltd, Unit A, Blackhill Road Holton Heath Industrial Park, Holton Heath BH16 6LS Poole Dorset United Kingdom
  • ESENCIAS MARTINEZ LOZANO S.A., Ctra. Lorca, Km 7 - Paraje Venta de Cavila 30400 Caravaca de la Cruz Murcia Spain
  • Fairoils SPRL, Rue des Gaulois 15 7822 Ghislenghien Belgium
  • Frey + Lau GmbH, Immenhacken 12 DE-24558 Henstedt-Ulzburg Germany
  • Global Essence UK Limited, Parklands Business Centre, Stortford Road, Leaden Roding CM6 1GF Dunmow Essex United Kingdom
  • GOLGEMMA SA, route de FA 11260 ESPERAZA Languedoc Roussillon France
  • H. REYNAUD & FILS, La Cheminade 26570 MONTBRUN LES BAINS France
  • HELPAC, DISTILLERIE DE SAINT HILAIRE 43390 SAINT HILAIRE France
  • IN-LUSTRYS, Montée des Chênes La Tuilière 83136 NEOULES VAR France
  • J C Buck Limited, Unit 8, The Stafford Estate Hillman Close, Ardleigh Green RM11 2SJ Hornchurch Essex United Kingdom
  • Johann Voegele KG, Bahnhofstrasse 143 74348 Lauffen Baden-Württemberg Germany
  • MCI Miritz Citrus GmbH & Co. KG (OR1), Citrusstraße 3 37318 Kirchgandern Germany
  • Naturally Innovative Limited, 8 Hampstead Gate 1A Frognal, NW36JY London Hampstead United Kingdom
  • Pure Australian Tea Tree Oil Limited (001), 13-18 City Quay D02 ED70 Dublin 2 Ireland
  • Pure Australian Tea Tree Oil Limited (002), 13-18 City Quay D02 ED70 Dublin 2 Ireland
  • Pure Australian Tea Tree Oil Limited (003), 13-18 City Quay D02 ED70 Dublin 2 Ireland
  • QUIMDIS SAS, 71, rue Anatole France 92532 Levallois-Perret France
  • R.C.Treatt & Co. Ltd., Northern Way IP32 6NL Bury St. Edmunds Suffolk United Kingdom
  • RCL Ireland (017), 6th Floor, South Bank House Barrow Street D04 TR29 Dublin Ireland
  • Reach Only Representative (Ireland) Ltd (grdavi), VPR House Main St F12 FC64 Swinford Co. Mayo Ireland
  • sa plantes aromatiques du diois, les marcelons 26340 Vercheny France
  • Stan Chem International Limited, 4 Kings Road RG1 3AA Reading Berkshire United Kingdom
  • Telmont Essentials (Ireland) PTE Limited, 84 Northumberland Road Dublin 4 Dublin Ireland
  • UMCO GmbH, Georg-Wilhelm-Straße 187 21107 Hamburg Germany
  • Univar BV, Schouwburgplein 30-34 NL-3012 CL Rotterdam Netherlands
  • Vossen & Co NV/SA, Av. Van Volxem 264, C1 1190 Brussels Belgium

Other names

  • -
  • Essential oil extract of Melaleuca alternifolia (Myrtaceae) leaf
  • Essential oil obtained from the leaves and terminal branchlets of Melaleuca alternifolia, by steam distillation
  • Essential oil of Melaleuca alternifolia
  • Essential oil of Melaleuca alternifolia (Myrtaceae) obtained by steam distillation of the leaves and terminal branchlets
  • HE Melaleuca alternifolia
  • Melaleuca Alternifolia (Tea tree) oil
  • melaleuca alternifolia leaf oi
  • MELALEUCA ALTERNIFOLIA LEAF OIL
  • Melaleuca alternifolia, ext
  • Melaleuca alternifolia, ext.
  • Melaleuca ericifolia
  • Melaleuca oil
  • Oil of Melaleuca, terpinen-4-ol type.
  • Reaction mass of pin-2(3)-ene and p-menth-1-en-8-ol and p-mentha-1,4-diene and p-mentha-1,3-diene and p-cymene and pin-2(10)-ene and 1-methyl-4-(1-methylethyl)-7-oxabicyclo[2.2.1]heptane and p-menth-1-en-4-ol and p-mentha-1,4(8)-diene and (R)-p-mentha-1,8-diene
  • Reaction mass of pin-2(3)-ene and p-mentha-1,4-diene and p-mentha-1,3-diene and p-cymene and dipentene and cineole and p-menth-1-en-4-ol and p-mentha-1,4(8)-diene and thuj-4(10)-ene and (R)-α,α,4-trimethylcyclohex-3-ene-1-methanol
  • TEA TREE ESSENTIAL OIL
  • TEA TREE OIL
  • TEA TREE OILTEA TREE OIL WILD GROWNTEA TREE OIL EXTRA PH. EUR.TEA TREE OIL ORGANIC
  • TeaTrea, ext.
  • Teatree oil
  • Teebaumöl
  • Melaleuca alternifolia, ext.
  • Melaleuca alternifolia, ext. (Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Melaleuca alternifolia, Myrtaceae.)
  • Te Tree Australian
  • Tea Tree Chinese
  • Tea Tree Essential Oil
  • Tea Tree Oil

Scientific properties

Physical and chemical properties

This section provides physicochemical information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Appearance/physical state / colour

Study results
  • 2 studies submitted
  • 2 studies processed
C Physical state at 20°C and 1013 hPa
Liquid (100%) [2]
C Form
Liquid (100%) [2]
C Odour
Other (100%) [2]
C Substance type
Natural substance (100%) [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Melting/freezing point

Study results
  • 2 studies submitted
  • 2 studies processed
R Melting / freezing point
-22 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Boiling point

Study results
  • 2 studies submitted
  • 2 studies processed
R Boiling point
97 - 220 °C @ 100.4 - 100.7 kPa [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Density

Study results
  • 2 studies submitted
  • 2 studies processed
R Relative density
0.89 @ 20 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Vapour pressure

Study results
  • 2 studies submitted
  • 2 studies processed
R Vapour pressure
21 hPa @ 25 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Partition coefficient

Study results
  • 2 studies submitted
  • 2 studies processed
R Pow
2 510 - 314 000 @ 30 °C [2]
R Log Pow
3.4 - 5.5 @ 30 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Water solubility

Study results
  • 2 studies submitted
  • 2 studies processed
R Water solubility (mass/vol.)
1.42 g/L @ 20 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Solubility in organic solvents / fat solubility

Data not provided by the registrant

Surface tension

Study results
  • 2 studies submitted
  • 2 studies processed
R Surface tension
55 mN/m @ 1 g/L and 20 °C [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Flash point

Study results
  • 4 studies submitted
  • 4 studies processed
R Flash point
54 - 55 °C @ 102.1 - 102.2 kPa [4]

Type of Study provided
Studies with data
Key study 4
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Auto flammability

Study results
  • 2 studies submitted
  • 2 studies processed
R Autoflammability / self-ignition
252 °C @ 101.7 - 102.2 kPa [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Flammability

Study results
  • 8 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible 4
Sci. unjustified 4
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Explosiveness

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Oxidising

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Oxidation reduction potential

Data not provided by the registrant

pH

Data not provided by the registrant

Dissociation constant

Data not provided by the registrant

Viscosity

Data not provided by the registrant

Environmental fate and pathways

This section provides environmental fate and pathways information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Phototransformation in air

Data not provided by the registrant

Hydrolysis

Study results
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Phototransformation in water

Data not provided by the registrant

Phototransformation in soil

Data not provided by the registrant

Biodegradation in water - screening tests

Study results
  • 4 studies submitted
  • 4 studies processed
C Interpretation of results
Readily biodegradable (50%), Readily biodegradable but failing the 10-day window (50%) [4]

Type of Study provided
Studies with data
Key study 4
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Biodegradation in water & sediment - simulation tests

Data not provided by the registrant

Biodegradation in soil

Data not provided by the registrant

Bioaccumulation: aquatic / sediment

Data not provided by the registrant

Bioaccumulation: terrestrial

Data not provided by the registrant

Adsorption/desorption

Study results
  • 2 studies submitted
  • 0 studies processed

No automatically processable data submitted

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Summaries
  • 0 summaries submitted
  • 0 summaries processed

No data available

Henrys law constant (H)

Data not provided by the registrant

Distribution modelling

Data not provided by the registrant

Ecotoxicological information

This section provides ecotoxicological information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Predicted No-Effect Concentration (PNEC)

R Summaries
  • 2 summaries submitted
  • 2 summaries processed

The Predicted No-Effect Concentration (PNEC) value is the concentration of a substance below which adverse effects in the environment are not expected to occur. Please note that when more than one summary is provided, PNEC values may refer to constituents of the substance and not to the substance as a whole. More detailed information is available in the dossiers.

Hazard for Aquatic Organisms
Freshwater 7.75 µg/L (2)
Intermittent releases (freshwater) 77.5 µg/L (2)
Marine water 775 ng/L (2)
Intermittent releases (marine water) 7.75 µg/L (2)
Sewage treatment plant (STP) 2.57 mg/L (2)
Sediment (freshwater) 37.11 mg/kg sediment dw (2)
Sediment (marine water) 3.711 mg/kg sediment dw (2)
Hazard for Air
Air No hazard identified (2)
Hazard for Terrestrial Organism
Soil 7.42 mg/kg soil dw (2)
Hazard for Predators
Secondary poisoning Insufficient hazard data available (further information necessary) (2)

Short–term toxicity to fish

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
LL50 (4 days) 7.75 mg/L [2]
LL50 (72 h) 10 mg/L [2]
LL50 (48 h) 10 mg/L [2]
LL50 (24 h) 10 mg/L [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
LC50 for freshwater fish
7.75 mg/L

Long–term toxicity to fish

Data not provided by the registrant

Short–term toxicity to aquatic invertebrates

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
EL50 (48 h) 13.6 mg/L [2]
EL50 (24 h) 16.6 mg/L [2]
NOELR (48 h) 10 mg/L [2]
NOELR (24 h) 10 mg/L [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
EC50 / LC50 for freshwater invertebrates
13.6 mg/L

Long–term toxicity to aquatic invertebrates

Data not provided by the registrant

Toxicity to aquatic algae and cyanobacteria

Study results
  • 4 studies submitted
  • 4 studies processed
P/RResults
EC50 (72 h) 80 mg/L [4]
EC10 (72 h) 2.38 - 27.34 mg/L [4]
EL10 (4 days) 25.7 - 29.9 mg/L [4]
EL50 (4 days) 30.8 - 35.9 mg/L [4]
NOELR (4 days) 20 mg/L [2]

Type of Study provided
Studies with data
Key study 4
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
EC50 for freshwater algae
35.9 mg/L
EC10 or NOEC for freshwater algae
29.9 mg/L

Toxicity to aquatic plants other than algae

Data not provided by the registrant

Toxicity to microorganisms

Study results
  • 2 studies submitted
  • 2 studies processed
P/RResults
EC50 (30 min) 257 mg/L [2]

Type of Study provided
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
R Summaries
  • 2 summaries submitted
  • 2 summaries processed
EC50 for microorganisms
257 mg/L

Sediment toxicity

Data not provided by the registrant

Endocrine disrupter testing in aquatic vertebrates – in vivo

Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods

Data not provided by the registrant

Toxicity to terrestrial arthropods

Data not provided by the registrant

Toxicity to terrestrial plants

Data not provided by the registrant

Toxicity to soil microorganisms

Data not provided by the registrant

Toxicity to birds

Data not provided by the registrant

Toxicity to mammals

Data not provided by the registrant

Toxicological information

This section provides toxicological information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Derived No- or Minimal Effect Level (DN(M)EL)

M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed

The derived no- or minimum effect level (DN(M)EL) is the level of exposure above which a human should not be exposed to a substance. Please note that when more than one summary is provided, DN(M)EL values may refer to constituents of the substance and not to the substance as a whole. More detailed information is available in the dossiers.

Data for WORKERS
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 658 µg/m³ repeated dose toxicity
Acute /short term: (DNEL) 658 µg/m³ repeated dose toxicity
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 4.356 mg/kg bw/day repeated dose toxicity
Acute /short term: (DNEL) 4.356 mg/kg bw/day repeated dose toxicity
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
EYE Exposure
No hazard identified
Data for the GENERAL POPULATION
INHALATION Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 296 µg/m³ repeated dose toxicity
Acute /short term: (DNEL) 296 µg/m³ repeated dose toxicity
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
DERMAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 1.556 mg/kg bw/day repeated dose toxicity
Acute /short term: (DNEL) 1.556 mg/kg bw/day repeated dose toxicity
Local Effects
Long-term: No hazard identified
Acute /short term: No hazard identified
ORAL Exposure Threshold Most sensitive study
Systemic Effects
Long-term: (DNEL) 67 µg/kg bw/day repeated dose toxicity
Acute /short term: (DNEL) 67 µg/kg bw/day repeated dose toxicity
EYE Exposure
No hazard identified

Toxicokinetics, metabolism, and distribution

Study results
Study data: basic toxicokinetics
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: basic toxicokinetics
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: dermal absorption
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: dermal absorption
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Bioaccumulation potential:
No bioaccumulation potential
Absorption values
Oral: 70 %
Dermal: 3 %
Inhalation: 100 %

Acute toxicity

Study results
oral
  • 4 studies submitted
  • 2 studies processed
P/RResults
LD50 1.9 - 2.6 mL/kg bw (rat) [4]
M/CInterpretations of results
Category 4 based on GHS criteria [2]

Type of Study provided
oral
Studies with data
Key study 2
Supporting study 2
Weight of evidence
Other
Data waiving
no waivers
inhalation
  • 2 studies submitted
  • 2 studies processed
P/RResults
LC50 (4 h) 4.29 - 5.23 mg/L air (rat) [6]
M/CInterpretations of results
Category 4 based on GHS criteria [2]

inhalation
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
dermal
  • 2 studies submitted
  • 2 studies processed
P/RResults
LD50 2 000 mg/kg bw (rabbit) [2]
M/CInterpretations of results
GHS criteria not met [2]

dermal
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
other routes
  • 0 studies submitted
  • 0 studies processed

No data available

other routes
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Oral route:
Adverse effect observed LD50 1 691 mg/kg bw
Inhalation route:
Adverse effect observed LC50 4 780 mg/m³

Irritation / corrosion

Study results
Study data: skin
  • 4 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
Study data: eye
  • 4 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: eye
Studies with data
Key study 4
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Skin
Adverse effect observed (irritating)
Eye
No adverse effect observed (not irritating)
Respiratory
No study available

Sensitisation

Study results
Study data: skin
  • 12 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: skin
Studies with data
Key study 2
Supporting study 8
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
Study data: respiratory
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: respiratory
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Skin sensitisation
No adverse effect observed (not sensitising)
Respiratory sensitisation
No study available

Repeated dose toxicity

Study results
Study data: oral
  • 2 studies submitted
  • 2 studies processed
P/RResults
NOAEL (rat): 45 mg/kg bw/day [2]

Type of Study provided
Study data: oral
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: inhalation
  • 0 studies submitted
  • 0 studies processed

No data available

Study data: inhalation
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: dermal
  • 0 studies submitted
  • 0 studies processed

No data available

Study data: dermal
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Oral route - systemic effects:
No adverse effect observed NOAEL 45 mg/kg bw/day (subacute, rat)

Genetic toxicity

Study results
Study data: in vitro
  • 6 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: in vitro
Studies with data
Key study 6
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: in vivo
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: in vivo
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Toxicity - InVitro
No adverse effect observed (negative)
Toxicity - InVivo
No study available

Carcinogenicity

Data not provided by the registrant

Toxicity to reproduction

Study results
Study data: reproduction
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Type of Study provided
Study data: reproduction
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
Not feasible
Sci. unjustified 2
Exposure cons.
Other
Study data: developmental
  • 2 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: developmental
Studies with data
Key study 2
Supporting study
Weight of evidence
Other
Data waiving
no waivers
Study data: other studies
  • 0 studies submitted
  • 0 studies processed

Study data not processed for brief profile

Study data: other studies
Studies with data
Key study
Supporting study
Weight of evidence
Other
Data waiving
no waivers
M/C Summaries
  • 2 summaries submitted
  • 2 summaries processed
Effect on developmental toxicity
Oral route:
Adverse effect observed NOAEL 20 mg/kg bw/day (subacute, rat)

Neurotoxicity

Data not provided by the registrant

Immunotoxicity

Data not provided by the registrant

Endocrine disrupter mammalian screening - in vivo

Data not provided by the registrant