GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 34256-82-1
Chemical name 2-Chloro-N-(ethoxymethyl)-2'-ethyl-6'-methylacetanilide
Substance ID 23A5106
Fiscal year of classification conducted FY2011
Classifier(s) (Ministries) Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
New/Revised New
Download in Excel format Excel file

REFERENCE INFORMATION

Item Information
Guidance used for classification (External link) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010)
Environmental Hazards: UN GHS Document (4th revised edition)
Definitions / Abbreviations (Excel file) Definitions / Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
1 Explosives Not applicable - - - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable - - - "Liquids" according to GHS definition.
3 Aerosols Not applicable - - - Not an aerosol product.
4 Oxidizing gases Not applicable - - - "Liquids" according to GHS definition.
5 Gases under pressure Not applicable - - - "Liquids" according to GHS definition.
6 Flammable liquids Not classified - - - A flash point of 160 degrees C [closed cup] (PM (14th, 2006)) is above 93 degrees C.
7 Flammable solids Not applicable - - - "Liquids" according to GHS definition.
8 Self-reactive substances and mixtures Not applicable - - - Containing neither chemical groups related to explosibility nor those related to self-reactivity.
9 Pyrophoric liquids Classification not possible - - - No data.
10 Pyrophoric solids Not applicable - - - "Liquids" according to GHS definition.
11 Self-heating substances and mixtures Classification not possible - - - No established test method suitable for liquid substances.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - An organic compound that contains oxygen and chlorine which are not chemically bonded to elements other than carbon or hydrogen.
14 Oxidizing solids Not applicable - - - "Liquids" according to GHS definition.
15 Organic peroxides Not applicable - - - An organic compound that does not contain -O-O- structure.
16 Corrosive to metals Classification not possible - - - No data.
Besides, there is information that it is slightly corrosive to mild steel (HSDB (2010)).

HEALTH HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - On the basis of an LD50 value of 2953 mg/kg for rats (HSDB (2010)), it was classified as "Not classified" in JIS classification (Category 5 in UN GHS classification).
1 Acute toxicity (Dermal) Not classified - - - On the basis of an LD50 value of 3667 mg/kg for rabbits (HSDB (2010)), it was classified as "Not classified" in JIS classification (Category 5 in UN GHS classification).
1 Acute toxicity (Inhalation: Gases) Not applicable - - - "Liquids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - No data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - No data.
2 Skin corrosion/irritation Classification not possible - - - Because the mild irritation reported in a standard Draize test in which 500 mg was applied to rabbit skins for 24 hours (RTECS (2010)) is the data from List 3 and unknown details, it was classified as "Classification not possible."
Besides, it is classified in Xi; R38 in EU classification.
3 Serious eye damage/eye irritation Classification not possible - - - Because the mild irritation reported in a standard Draize test in which 100 mg was applied to rabbit eyes (RTECS (2010)) is the data from List 3 and unknown details, it was classified as "Classification not possible."
4 Respiratory sensitization Classification not possible - - - No data.
4 Skin sensitization Classification not possible - - - No data.
Besides, it is classified in Xi; R43 in EU classification.
5 Germ cell mutagenicity Classification not possible - - - No data.
6 Carcinogenicity Category 1B

Danger
H350
P308+P313
P201
P202
P281
P405
P501
Because it is classified in "L" in Carcinogen Assessment in EPA (EPA TRED (2006)), it is classified in Category 1B.
Besides, increased incidence of lung tumors in male and female mice, histiocytic sarcoma in female mice, nasal epithelial tumors, and thyroid follicular cell adenomas in male and female rats were observed (EPA TRED (2006)).
7 Reproductive toxicity Category 2

Warning
H361
P308+P313
P201
P202
P281
P405
P501
A slight decrease (about 20%) in litter size was observed in the highest dose group (5000 ppm; males 325 mg/kg/day, females 442 mg/kg/day) where general toxicity, such increased chronic nephritis, was observed in two-generation reproduction toxicity test in rats by dietary administration. Increased resorptions per dam and postimplantation loss were observed in the highest dose group (600 mg/kg/day) where general toxicity, such decreased weight gain, was observed in maternal animals in a developmental toxicity test in rats by the oral administration during an organogenetic period (IRIS (2002)). Therefore, it was classified in Category 2.
Besides, an oral administration test in rabbits during an organogenetic period reported a decreased weight gain in maternal animals but no adverse effects on fetal development (IRIS (2002)).
8 Specific target organ toxicity - Single exposure Classification not possible - - - No data.
9 Specific target organ toxicity - Repeated exposure Category 1 (kidney, testis), Category 2 (central nervous system)

Danger
Warning
H372
H373
P260
P264
P270
P314
P501
Effects on kidney and testis were observed at doses equal to or higher than the upper limit (10 mg/kg/day) of a range of Category 1 in Guidance values in one-year feeding study in dogs. The kidney changes consisted of interstitial nephritis and chronic vasculitis, testicular toxicity consisted of atrophy, degeneration of seminiferous tubules, and hypospermia in the epididymis, and evident renal toxicity and testicular toxicity were described (IRIS (2002)). Therefore, it was classified in Category 1 (kidney, testis).
Furthermore, neurologic effects such as abnormal head movements, stiffness and rigidity of the hindlimbs, ataxia, tremor, and depressed righting, hopping, and flexor reflexes accompanied by histopathological changes in the vermis cerebellum were observed at 50 mg/kg/day corresponding to Category 2 in Guidance values (IRIS (2002)), therefore, it was classified in Category 2 (central nervous system).
Besides, decreases in hemoglobin, hematocrit, red blood cell count and increases in liver enzymes such as ALT and gamma-GTP were reported but were not used as bases for classification due to no accompanying histopathological changes.
A two-year feeding study in mice also reported increased interstitial nephritis in the kidney in the highest dose group (750 mg/kg/day) (IRIS (2002)).
10 Aspiration hazard Classification not possible - - - No data.

ENVIRONMENTAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 1

Warning
H400
P273
P391
P501
From 96-hour EC50 = 0.0034 mg/L for algae (Skeletonema costatum) (AQUIRE, 2012), it was classified in Category 1.
11 Hazardous to the aquatic environment (Long-term) Category 1

Warning
H410
P273
P391
P501
Reliable chronic toxicity data were not obtained.
Due to lack of rapid degradability (BIOWIN), and acute toxicity Category 1, it was classified in Category 1.
12 Hazardous to the ozone layer Classification not possible - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.



Updated date:
2016/8/17 Addition of Rationale for the classification

List of GHS Classification Results