GHS Classification Result

Chemical Name：Tetrasodium ethylenediaminetetraacetate
CAS：64-02-8

Result：
ID: 22A4024
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government （July, 2010）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement 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 - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solids Classification not possible - - - - Since no test results are available, classification is not possible. As relevant notes, it is reported that this substance is combustible (ICSC (2006)) and it doesn't easily ignite (nicht leichtentzuendlich) (IUCLID (2000)).
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - Since its auto ignition point is 260 degC (Selbstentzuendung rnit Luft bei 260 Grad C.) (IUCLID (2000), Original literature: BASF AG Ludwigshafen), it is considered that the substance does not ignite at room temperature.
11 Self-heating substances and mixtures Classification not possible - - - - Since no test results are available, classification is not possible. As relevant note, it is reported that this substance is combustible (ICSC (2006)) and it doesn't easily ignite (nicht leichtentzuendlich) (IUCLID (2000)).
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified - - - - Although it contains a metal (Na), its water solubility is 103 g/100 mL (Merck (14th, 2006)) and it is considered that the substance doesn't react strongly with water.
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Classification not possible - - - - Although this substance is an organic compound containing oxygen which is chemically bonded to Na, other than carbon or hydrogen, due to lack of additional data, classification is not possible.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ... 		The five LD50 values of 2700, 3200, 1700, 1780 - 1913 and 1210 - 2150 mg/kg for rats were documented in the data from the "List 1" information source designated in the GHS classification guidance for the Japanese government (EU-RAR (2004)). The two data are equivalent to the guidance value of Category 4, the other two are "Not classified" category (corresponding to Category 5 in the UN-GHS classification), and the other one is Category 4 or Category 5. The applicable amount of the data for each Category 4 and "Not classified" category was the same. Selecting the category of greater hazard, the substance was classified as Category 4.
1 Acute toxicity （Dermal） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - The classification was not possible due to lack of data. Although it was reported that no mortalities occurred in the 8-hour inhalation test for rats with dust (EU-RAR (2004)), the test concentration was uncertain.
2 Skin corrosion/irritation Not classified - - - - In the rabbit test (OECD TG 404) by contact with 80% aqueous solution for 4 hours, the average score of erythema at 24, 48 and 72 hours after application were 1, 0, and 0.3, respectively, and the symptoms disappeared after 8 days. Edema was not observed (EU-RAR (2004)). Based on the result, the substance was classified as "Not classified". In other rabbit studies by contact with 80% aqueous solution for 20 hours, severe erythema and exfoliation were observed after 24 hours and 8 days respectively. But edema was not observed (EU-RAR (2004)).
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection. 		In the rabbit test, instillation of 50 mg of an 88% aqueous preparation of the substance to the eye of one rabbit resulted in strong irritation at 1 - 24 hours application, and extreme edema, mild corneal opacity, pus formation were observed. After 8 days, a mild corneal opacity was seen (EU-RAR (2004)). In the other rabbit test which exposed 0.1ml of 40% aqueous preparation of the substance to the eye of three rabbits, irritation scores after 72 hours were 1 for corneal opacity, 1 for iritis, 3 for conjunctivae redness and 2 - 3 for chemosis (EU-RAR (2004)). Based on the information, the substance was classified as Category 2A.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - Insufficient data were available. As relevant information, a 78-year-old woman with recurrent leg ulcers revealed a positive response by twice contact to the aqueous solution of this substance (EU-RAR (2004)).
5 Germ cell mutagenicity Classification not possible - - - - The classification was not possible due to lack of in vivo test data. As relevant information, as for in vitro studies, negative results were reported in the Ames test (HSDB (2004)), the chromosome aberration test using CHO cells, and the transformation test using Syrian hamster embryo cells (IUCLID (2000)).
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Classification not possible - - - - In the developmental toxicity test in rats by oral administration of the test substance from 7th to 14th day of gestational period, general toxic signs containing diarrhea and depression of activity and reduced weight gain were observed in the dams, while the mortality index of offspring by postimplantation loss, litter size and mean fetal body weight were comparable to that of the control group. The evidence indicated the teratogenicity was not found in the external, visceral and skeletal examinations (EU-RAR (2004)). However, since sufficient information was not provided regarding sexual functions and fertility of parental animals, the substance was classified as "Classification not possible".
8 Specific target organ toxicity - Single exposure Category 2 (systemic toxicity) Warning H371: May cause damage to organs (systemic toxicity) P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P405: Store locked up.
P501: Dispose of contents/container to ... 		It was reported that there were multiple data on acute oral toxicity studies with rats (LD50 value: 1210 - 3200 mg/kg), and the most prominent clinical signs were dyspnea, ataxic gait, abnormal gait, tremor or piloerection, and that autopsy findings of redness and hemorrhagic ulcer of the glandular part of the stomach, redness of the mucous membranes of the intestine and systemic hyperemia or flaccid intestines (EU-RAR (2004)). It was difficult to identify the target organ(s) from the findings described above, and the effects were seen in the doses equivalent to Category 2 of the guidance values or more. Therefore, the substance was classified as Category 2 (systemic toxicity).
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - No data available.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Category 2 - - H401: Toxic to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ... 		Classified into Category 2 from its 72h-EC50 = 1.01 mg/L for algae (Scenedesmus subspicatus) (EU-RAR, 2004; IUCLID, 2000).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Classified as "Not classified" by expert judgement; although its acute toxicity is Category 2, it can be judged that the acute toxicity value does not indicate the true toxicity of the substance according to the OECD guidance document No.23, therefore it should not be used for chronic hazard classification of the substance.
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTE:
* 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.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

To GHS Information