GHS Classification Result (Revision of the past classification result)

Chemical Name:Ethylene glycol monobutyl ether acetate
CAS:112-07-2

Result:
ID: 21C0007
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2009
Reference Manual: GHS Classification Guidance by the Japanese Government (March, 2009)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives - - - - -
2 Flammable gases (including chemically unstable gases) - - - - -
3 Aerosols - - - - -
4 Oxidizing gases - - - - -
5 Gases under pressure - - - - -
6 Flammable liquids - - - - -
7 Flammable solids - - - - -
8 Self-reactive substances and mixtures - - - - -
9 Pyrophoric liquids - - - - -
10 Pyrophoric solids - - - - -
11 Self-heating substances and mixtures - - - - -
12 Substances and mixtures which, in contact with water, emit flammable gases - - - - -
13 Oxidizing liquids - - - - -
14 Oxidizing solids - - - - -
15 Organic peroxides - - - - -
16 Corrosive to metals - - - - -

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) - - - - -
1 Acute toxicity (Dermal) - - - - -
1 Acute toxicity (Inhalation: Gases) - - - - -
1 Acute toxicity (Inhalation: Vapours) - - - - -
1 Acute toxicity (Inhalation: Dusts and mists) - - - - -
2 Skin corrosion/irritation - - - - -
3 Serious eye damage/eye irritation - - - - -
4 Respiratory sensitization - - - - -
4 Skin sensitization - - - - -
5 Germ cell mutagenicity - - - - -
6 Carcinogenicity Not classified - - - - The substance is classified into "Group 3" in IARC (IARC 88 (2006)) and "A3" in ACGIH (ACGIH (2003)). Based on the newer IARC information, the substance was classified as "Not classified". Assessment of the toxicity of the glycol ether acetate EGBEA based on the data for ethylene glycol mono-n-butyl ether (111-76-2) is appropriate since glycol ether acetates are rapidly hydrolyzed to their glycol ethers in vivo (SIDS (access on June 2008)). In 2-year inhalation tests with ethylene glycol mono-n-butyl ether in rats and mice, an increase in the incidence of combined benign plus malignant pheochromocytomas of the adrenal medulla in female rats was equivocal, however the incidences of liver hemangiosarcoma in male mice and squamous cell papilloma or squamous cell carcinoma in female mice were increased (SIDS (access on June 2008)).
7 Reproductive toxicity - - - - -
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, blood, systemic toxicity), Category 2 (kidney) Danger
Warning
H370: Causes damage to organs (central nervous system, blood, systemic toxicity)
H371: May cause damage to organs (kidney)
P307+P311: IF exposed: 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.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
In an acute dermal toxicity test with rabbits (LD50 value of 1500 mg/kg: corresponds to Category 2), hemoglobinuria, hematuria, decreases in red blood cells and blood hemoglobin, and tubular necrosis with occasional glomerular lesions were observed (SIDS (access on June 2008)). In an acute oral toxicity test with rabbits (LD50 value of 2400 - 3300 mg/kg: corresponds to "Not classified"), hemoglobinuria, hematuria, nephrosis, tubular dilation, tubular necrosis and hyaline droplet degeneration were noted (SIDS (access on June 2008)). Additionally, slight hemoglobinuria and hematuria were noted at a dose level of 400 ppm (2.6 mg/L: corresponds to Category 2) (SIDS (access on June 2008)). Based on the data, the blood system and kidney were regarded as target organs. In a case of an 18-year old male ingesting 360 - 480 mL of window cleaning product containing 22% ethylene glycol monobutyl ether (2-butoxyethanol (the metabolite)), CNS depression and metabolic acidosis were observed (SIDS (access on June 2008)). In a second case, a 50-year old woman ingested a window cleaning product (i.e. 30 - 60 mL butoxyethanol) with the main effects being coma, absence of response to pain stimulus, breathing difficulties, metabolic acidosis, hypokalemia, and haemoglobinuria inducing progressive erythropenia (SIDS (access on June 2008)). In a third case, a 23-year old woman ingested a window cleaning product (i.e. 63 mL butoxyethanol) with the main effects being coma, dilated pupils, obstructive respiration, metabolic acidosis, hyperventilation, depression of blood haemoglobin concentration and haematuria. (SIDS (access on June 2008)). As reported, CNS depression, metabolic acidosis, erythropenia and decreased hemoglobin are noted in humans following ingestion of the substance. Based on the human data, the substance was classified into Category 1 (central nervous system, blood system, systemic toxicity). In addition, based on the rat data reported above, the substance was classified into Category 2 (kidney).
9 Specific target organ toxicity - Repeated exposure Category 2 (blood, kidney) Warning H373: May cause damage to organs through prolonged or repeated exposure (blood, kidney) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
In a 30-day inhalation test with rats death, hemoglobinuria, hematuria, decreased red blood cell counts and hemoglobin values, hypertrophic and swollen kidney and nephrosis were observed at a dose level of 400 ppm/4h (90-day, 6h/day equivalence: approximately 0.71 mg/L/6h) which is within the guidance value range for Category 2. In 4-week inhalation tests with rats, rabbits and cats (exposure for 6-hour a day), anemia such as a decrease in hemoglobin and hematocrit was reported as a characteristic finding at 2.3 mg/L (90-day equivalence: approximately 0.71 mg/L) which is within the guidance value range for Category 2 (SIDS (access on June 2008)). Since these findings were noted at dose levels within the guidance value range for Category 2, the substance was classified into Category 2 (blood system, kidney). For ethylene glycol monobutyl ether acetate which is an in vivo hydrolysate of ethylene glycol monobutyl ether acetate, in 14-week inhalation tests in rats and mice, hemolytic anemia and histological lesions consistent with hemolytic anemia in liver, kidney, bone marrow and spleen were observed at dose levels of 62.5 - 125 ppm (within the guidance value range for Category 2) in both species (SIDS (access on June 2008)).
10 Aspiration hazard - - - - -

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) - - - - -
11 Hazardous to the aquatic environment (Long-term) - - - - -


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)


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