GHS Classification Result

Chemical Name:3-Phenylazo-2,6-pyridinediamine hydrochloride, (alias Phenazopyridine hydrochloride)
CAS:136-40-3

Result:
ID: 21A3749
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 - - - - Judged not to be explosive since the substance is "aromatic azo" though it contains chemical groups (azo group) associated with explosive properties present in the molecules.
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 - - - - No data available.
8 Self-reactive substances and mixtures Not applicable - - - - Judged not to be explosive since the substance is "aromatic azo" though there are chemical groups (azo group) associated with explosive properties present in the molecules.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - No data 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 - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance contains chlorine which is chemically bonded only to hydrogen.
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 ...
Based on a LD50 value of 403 mg/kg for rats (HSDB (2009)), the substance was classified into 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 - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
From in vivo mutagenicity tests, there are reports of positive results in a micronucleus test and a DNA damage test, however, the details are unknown (RTECS (2008): Mutation Research, vol. 389, p. 3 (1997): Mutation Research, vol. 465, p. 11 (2000)). As relevant information, from in vitro mutagenicity tests, there are reports of positive results in one of two Ames tests, a mouse lymphoma test and a CHO cell chromosomal aberration test (NTP DB (access on Oct. 2009)). Based on these results, the substance was classified into Category 2.
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
Based on the classification of "Group 2B" in IARC (IARC suppl. 7 (1987)), the substance was classified into Category 2. In one limited epidemiological test, no significant excess of any cancer was observed among 2214 patients who received the substance and were followed for a minimum of 3 years. However, oral administration increased the incidence of hepatocellular adenomas and carcinomas in female mice and induced tumours of the colon and rectum in male and female rats (IARC vol. 24 (1980)).
7 Reproductive toxicity Classification not possible - - - - No data available.
8 Specific target organ toxicity - Single exposure Category 1 (blood, liver, kidney) Danger H370: Causes damage to organs (blood, liver, 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 ...
There is a report that toxic signs which occur in humans given large doses of the substance include methaemoglobinaemia, Heinz-body formation, haemolytic anaemia, renal failure, hepatic enlargement, jaundice and hypersensitivity hepatitis (IARC vol. 24 (1980)). Additionally, there are report that methemoglobinemia constituted key feature in 7 human intoxications and that a child ingesting the substance exhibited hepatic enlargement and transiently abnormal renal function (HSDB (2009)). Based on these information, the substance was classified into Category 1 (blood system, liver, kidney). As relevant information, the substance is used as an analgesic drug with local anesthetic activity (IARC vol. 24 (1980)).
9 Specific target organ toxicity - Repeated exposure Category 2 (kidney) Warning H373: May cause damage to organs through prolonged or repeated exposure (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 ...
Based on reports that calculi composed of the free compound were found in the urinary tract of a 67 year old man who had been taking the substance daily for 2 years, and that the free compound was deposited on ureteral stones already present in a 55 year old man with chronic prostatitis who had taken the substance three times a day for 5 months (HSDB (2009)), the substance was classified into Category 2 (kidney). As relevant information, in a 45-day oral test in rats and mice, there was no gross pathological abnormalities (NTP TR99 (1978)).
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) Classification not possible - - - - No data available.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - - No data available.


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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