GHS Classification Result （Revision of the past classification result）

Chemical Name：Glutaraldehyde
CAS：111-30-8

Result：
ID: 21B3001
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 Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Liquid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products
4 Oxidizing gases Not applicable - - - - Liquid (GHS definition)
5 Gases under pressure Not applicable - - - - Liquid (GHS definition)
6 Flammable liquids Category 4 - Warning H227: Combustible liquid P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. - No smoking.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ... 		Classified into Category 4 since flash point ca. 71 degC (Hommel (1996)), 71 degC (IUCLID (2000), Hazard Data Book for Chemical Substance (CERI) (2002)) is >60 degC and <=93 degC.
7 Flammable solids Not applicable - - - - Liquid (GHS definition)
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 classified - - - - Auto-ignition point is 225 degC (IUCLID (2000), Hazard Data Book for Chemical Substance (CERI) (2002)) exceeding 70 degC.
10 Pyrophoric solids Not applicable - - - - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to liquid substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - - The substance contains oxygen (but not fluorine or chlorine) in the molecule which is chemically bonded only to carbon.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 3 Danger H301: Toxic if swallowed P301+P310: IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment （see ... on this label）.
P330: Rinse mouth.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Multiple LD50 values for rats are reported. LD50 values are 320 mg/kg (DFGOT vol. 8 (1997)), 409, 497, 605 and 733 mg/kg (NICNAS (1994))) correspond to Category 4, and LD50 values are 66, 77, 96, 99, 100, 100, 111, 113, 123, 123, 134, 137, 153, 165, 165, 168, 168 and 183 mg/kg (NICNAS (1994))) correspond to Category 3. The substance was classified into Category 3 since 18 of 23 LD50 values are in this category.
1 Acute toxicity （Dermal） Category 4 Warning H312: Harmful in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... 		Multiple LD50 values for rabbits are reported. Two values (900 and 1000 mg/kg (NICNAS (1994)) correspond to Category 3; two values (1360 and 1430 mg/kg (NICNAS (1994)) correspond to Category 4, and two values (2130 and 3045 mg/kg (NICNAS (1994)) correspond to "Not classified" in JIS Classification (correspond to Category 5 in GHS classification). The substance was classified into Category 4 in accordance with the expert opinions.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Category 1 Danger H330: Fatal if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P284: Wear respiratory protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P320: Specific treatment is urgent （see ... on this label）.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Based on LC50 values of 23.5 ppm and 40.1 ppm for rats (NICNAS (1994)), the substance was classified into Category 1. Since the test concentration was lower than 90% of saturated vapour pressure concentration, classification criteria for gas (ppm) was adopted.
1 Acute toxicity （Inhalation: Dusts and mists） Category 2 Danger H330: Fatal if inhaled P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P284: Wear respiratory protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P320: Specific treatment is urgent （see ... on this label）.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Based on LC50 values of 0.8 mg/L (correspond to Category 3) and 0.48 mg/L (correspond to Category 2) for rats (DFGOT vol. 8 (1997)), the lower value was adopted and the substance was classified into Category 2. Since there was a report of "aerosol" in the document, the test was considered to be conducted for mists.
2 Skin corrosion/irritation Category 1 Danger H314: Causes severe skin burns and eye damage P301+P330+P331: IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.
P303+P361+P353: IF ON SKIN （or hair）: Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In a rabbit skin irritation test, erythema and oedema as well as necrosis were observed in all six rabbits at concentrations of 10% and higher (NICNAS (1994)). In a second test, it is reported that the substance was "highly irritating" after a 1-hour application and "corrosive" after a 4-hour application (DFGOT vol. 8 (1997)). Based on these data, the substance was classified into Category 1. As relevant information, there are numerous case reports that occupationally exposed humans (especially hospital workers) experienced skin irritation or dermatitis (NICNAS (1994)).
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician. 		In a rabbit eye irritation test, severe and persistent conjunctival irritation and necrosis was observed. The effects persisted in one-half of the animals for 2 weeks) (NICNAS (1994)). In a second test, cornea opacity worsened up to the end of the observations at 72-hour (NICNAS (1994)). Based on the data, the substance was classified into Category 1. In humans, there are reports of accidental exposure cases showing conjunctival inflammation, eyelid edema, photophobia and etc. (ACGIH (2008)).
4 Respiratory sensitization Category 1 Danger H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled P304+P341: IF INHALED: If breathing is difficult, remove victim to fresh air and keep at rest in a position comfortable for breathing.
P342+P311: If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P285: In case of inadequate ventilation wear respiratory protection.
P501: Dispose of contents/container to ... 		There are many case reports of asthma and asthma-like symptoms with rhinitis or breathing difficulties in humans exposed to the substance (NICNAS (1994)). A report concluded that workers had occupational asthma due to substance exposure based on bronchial challenge tests (ACGIH (2001)). In addition, the substance is on the respiratory tract sensitizer list by Japan Society For Occupational Health (JSOH) (Recommendations for allowable concentrations (2005)) and on the sensitizing chemical substance list by Japanese Society of Occupational and Environmental allergy (ALGY society, list of (sensitizing) substances (draft), p 95). The substance was classified into Category 1. In an animal test (guinea pigs), no positive response was observed (NICNAS (1994)).
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... 		There are many reports that health care workers in hospital developed contact dermatitis and positive reactions were obtained by patch testing (NICNAS (1994), DFGOT vol. 8 (1997)), which were considered to be allergic an reaction. The results of "Maximization test", "modified Magnusson-Kligman test" and "Buehler test" using guinea pigs were all positive (NICNAS (1994), ECETOCTR77 (1999)). Based on these data, the substance was classified into Category 1.
5 Germ cell mutagenicity Not classified - - - - Based on negative results in a mouse dominant lethal test (in vivo heritable mutagenicity test), a mouse peripheral blood micronucleus test and a rat bone marrow chromosomal aberration test (in vivo somatic cell mutagenicity tests) (NICNAS (1994)), the substance was classified as "Not classified". As relevant information, from in vitro mutagenicity tests, there are many reports of positive (with or without S9) Ames tests (NTP TR490 (1999)). Additionally, there are reports of negative (NICNAS (1994)) and positive (NTP TR490 (1999)) mouse lymphoma cell forward mutation tests as well as negative to weakly positive CHO cell chromosomal aberration tests (NICNAS (1994), NTP TR490 (1999)).
6 Carcinogenicity Not classified - - - - Based on the classification of "A4" in ACGIH (1997), the substance was classified as "Not classified". There are no reports of classification by other organizations. In Fischer 344 rats given glutaraldehyde in drinking water for 104 weeks, decreased incidence of large granular lymphocytic leukemia was observed in females, however, the biological significance the finding is unclear since there was no clear dose-response relationship (Initial Risk Assessment Report (NITE, CERI, NEDO) (2008)). No treatment related increases in incidence of neoplasms, including neoplastic lesion in the nasal cavity and trachea, were observed in male or female F344 rats or B6C3F1 mice following inhalation exposure to glutaraldehyde for 78 - 104 weeks (NTP TR490 (1999)).
7 Reproductive toxicity Not classified - - - - In developmental toxicity tests by oral administration to rats rabbits or mice during organogenesis period, there were no adverse effects on fetal development including teratogenicity (NICNAS (1994), DFGOT vol. 8 (1997)). Exposure for two generations resulted in a decrease in body weights of the maternal animals and offspring, but no adverse effects on reproduction were observed (NTP TR490 (1999)). Based on the information, the substance was classified as "Not classified".
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system), Category 3 (respiratory tract irritation) Danger
Warning 		H370: Causes damage to organs (central nervous system)
H335: May cause respiratory irritation (respiratory tract irritation) 		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 ...
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell. 		After a single exposure, the CNS symptoms such as sluggishness, slow righting reflex and decreased motor activity were observed in rats at dose levels of 50 - 200 mg/kg for oral administration and 10.6 - 42.7 ppm for inhalation administration (vapour) (NICNAS (1994)). At the oral lethal dose level for rodents, the animals showed symptoms of depressive effects to the CNS, cramps and difficulty in breathing (GESTIS (access on April 2009)). Based on these reports, the substance was classified into Category 1 (central nervous system). There are epidemiological reports showing a clear association between upper respiratory tract irritation and occupational exposure concentration (in hospital) (DFGOT vol. 8 (1997)). Additionally, there are reports of airway irritation symptoms such as reduction in the respiration rate and squamous coagulation in rat and mouse inhalation tests (NICNAS (1994), ACGIH (2001), DFGOT vol. 8 (1997)). Based on these reports, the substance was classified into Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 1 (Inhalation: respiratory tract) Danger H372: Cause damage to organs through prolonged or repeated exposure (Inhalation: respiratory tract) 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.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		In 13-week inhalation tests in rats and mice, lesions in the respiratory system (larynx, nose, trachea) such as necrosis and inflammation were observed (NTP TR490 (1999)). In the other tests, lesions in the upper respiratory system such as neutrophil infiltration in squamous epithelium of the nasal vestibule and destruction or fusion of the turbinate were observed but no histopathological changes were noted in any tissues other than the respiratory system (NTP TR490 (1999), ACGIH (2001)). Since these changes were observed at 0.5 - 1 ppm and are considered to be significant toxic effects including deaths, the substance was classified into Category 1 (respiratory system). Oral administration did not cause these effects on the respiratory system) (NICNAS (1994)).
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 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Classified into Category 1 from its 48h-EC50 = 0.75 mg/L for Crustacea (Daphnia magna) (U.S. EPA: RED, 2007).
11 Hazardous to the aquatic environment （Long-term） Not classified - - - - Classified into Not classified since it is judged to be degraded rapidly in the environment and low bioaccumulative potential is estimated (log Kow = -0.18 (PHYSPROP Database, 2009)) from which it is judged to be easily biodegradable in the data (Readily biodegradable, BOD degradation rate: 59%, TOC degradation rate: 86%, GC degradation rate: 100%) (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1995)) and in SIDS (SIDS, 1998).
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