Registration Dossier

Classification & Labelling & PBT assessment

GHS

General Information

Name:
D-Tetramethrin
Implementation:
EU
Type of classification:
harmonised classification
Remarks:

Although d-Tetramethrin (CAS nr. 548460-64-6) is not specifically subject to harmonized classification according to the 13th ATP of CLP (COMMISSION REGULATION (EU) 2018/1480), Tetramethrin (CAS nr. 7696-12-0) is listed in the ATP, hence it is considered appropriate reading-across the same classification to d-Tetramethrin.

In acute toxicity studies by oral, dermal, and inhalation exposure, no mortality was seen at 2000 mg/kg bw, 2000 mg/kg bw, and 5.63 mg/L, respectively. Thus, the substance does not require classification for acute toxicity according to CLP (Regulation EC No. 1272/2008).

However, with a Decision adopted on 16 September 2016, RAC concluded that Tetramethrin should be classified as Acute Toxicity Category 4, via oral route (H302: Harmful if swallowed) based on a study on d-trans-tetramethrin in mices.

In addition RAC agreed on classification as STOT SE 2 (H371; by inhalation route) on the basis of evidence from studies on d-trans-tetramethrin and Tetramethrin in experimental animals at a moderate concentration. The observed neurotoxic effects were essentially acute effects. The same classification as Acute Toxicity Category 4, via oral route (H302: Harmful if swallowed) and STOT SE 2 (H371; by inhalation route)

is applied to d-Tetramethrin.

No data on carcinogenicity are available for d-Tetramethrin (CAS nr.548460-64-6) at Endura as this is not a data requirement for the current registration tonnage band (10 -100 t/y)

According to the RAC opinion, Tetramethin has been classified for carcinogenicity Category 2 (H351: Suspected of causing cancer) based on two independent rat studies not available at Endura, demonstrating a statistically significant increase in the incidence of Leydig cell tumors in male rats. The same classification for carcinogenicity Category 2 (H351: Suspected of causing cancer) is attributed to d-Tetramethrin.

Based on the lowest acute toxicity observed in a study not available at Endura, Tetramethrin is classified as: Aquatic Acute 1 (H400) with an acute M-factor of 100, Aquatic Chronic 1 (H410) with a chronic M-factor of 100.

According to RAC Decision adopted on 16 September 2016, based on the lowest acute toxicity observed in a study not available at Endura, Tetramethrin is classified as: Aquatic Acute 1 (H400) with an acute M-factor of 100, Aquatic Chronic 1 (H410) with a chronic M-factor of 100.

Although d-Tetramethrin (CAS nr.548460-64-6) is not specifically discussed in the RAC Decision adopted on 16 September 2016, it is considered appropriate reading-acrossthe same M-factors to d-Tetramethrin.

Related composition

Related composition:
Composition 2
Composition 1

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 lacking
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
Reason for no classification:
data conclusive but not sufficient for classification
Flammable solids
Reason for no classification:
data conclusive but not sufficient for classification
Self-reactive substances and mixtures
Reason for no classification:
data lacking
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 lacking
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 conclusive but not sufficient for classification
Acute toxicity - oral
Hazard category:
Acute Tox. 4
Hazard statement:
H302: Harmful if swallowed.
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
Reason for no classification:
data conclusive but not sufficient for classification
Aspiration hazard
Reason for no classification:
data conclusive but not sufficient for classification
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
Hazard category:
Carc. 2
Hazard statement:
H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>.
1. Specific target organ toxicity - single
Hazard category:
STOT Single Exp. 2
Hazard statement:
H371: May cause damage to organs <or state all organs affected, if known> <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Affected organs:
nervous system
Route of exposure:
Inhalation
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 1
Hazard statement:
H410: Very toxic to aquatic life with long lasting effects.
M-Factor acute:
100
M-Factor chronic:
100
Hazardous to the ozone layer
Reason for no classification:
data conclusive but not sufficient for classification

Labelling

Signal word:
Warning

Hazard pictogram

GHS07: exclamation mark
GHS08: health hazard
GHS09: environment

Hazard statements

H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>.
H302: Harmful if swallowed.
H371: May cause damage to organs <or state all organs affected, if known> <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
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+P312: IF SWALLOWED: Call a POISON CENTER/doctor/... if you feel unwell.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.

Notes