GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 139-40-2 |
| Chemical Name | Propazine |
| Substance ID | H28-A-017, C-059A |
| Classification year (FY) | FY2016 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | New |
| Classification result in other fiscal year | |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| UN GHS document (External link) | UN GHS document |
| 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 |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
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 |
- |
- | - | No data available. |
| 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 | 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 is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Not classified |
- |
- | - | Based on the LD50 value of 3,840 mg/kg for rats (PATTY (6th, 2012)), the substance was classified as "Not classified" (Category 5 in UN GHS classification). |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on a report that in an acute dermal exposure test using rabbits, no death case was observed at 10,200 mg/kg, LD50 value is thought to be greater than 10,200 mg/kg (PATTY (6th, 2012)). Therefore, the substance was classified as "Not classified." |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. Besides, it is estimated to be Category 3, Category 4 or "Not Classified," based on the 1h-LC50 values of > 14,000 mg/m3 (> 3.5 mg/L/4h) and > 3,300 mg/m3 (> 0.825 mg/L/4h) for rats (PATTY (6th, 2012)). However, it is difficult to classify based only on these values. |
| 2 | Skin corrosion/irritation | Not classified |
- |
- | - | This substance had no effect on the skin of either rabbits or guinea pigs (PATTY (6th, 2012)). Moreover, EPA TRED (2006) assessed it is not a skin irritant. Therefore, the substance was classified as "Not classified." |
| 3 | Serious eye damage/eye irritation | Category 2B |
Warning |
H320 |
P305+P351+P338
P337+P313 P264 |
EPA TRED (2006) assessed that it is not an eye irritant. However, it is reported that mild irritation was noted in the eyes of rabbits after instillation of this substance (PATTY (6th, 2012)). Therefore, the substance was classified in Category 2B. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | EPA TRED (2006) assessed that this substance is not a dermal sensitizer. However, since there is no other information source that evaluated this substance as not skin sensitizing, the substance was classified as "Classification not possible." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | As for in vivo data, it is reported that chromosomal aberration test using Chinese hamsters administered by oral was negative (HSDB (Access on June 2016)). As for in vitro data, it is reported that bacterial reverse mutation test was negative, and that in vitro mammalian cell gene mutation test was positive (PATTY (6th, 2012), HSDB (Access on June 2016)). Therefore, the substance was classified as "Classification not possible" according to the GHS classification guidance for the Japanese Government. |
| 6 | Carcinogenicity | Category 2 |
 Warning |
H351 |
P308+P313
P201 P202 P280 P405 P501 |
In a 2-year feeding carcinogenic study using rats, an increase in mammary tumors in females was observed in the high dose (1,000 ppm) group, in which a decrease in body weight in both sexes were found (PATTY (6th, 2012), HSDB (Access on June 2016)). On the other hand, it is reported that no carcinogenic response was observed in an oral administration study (administered by gavage from 7 through 28 days of age, followed by feeding for 18 months) and a subcutaneous injection study (a single 1,000 mg/kg dose, followed by 18-month observation) both using two different strains of mice (PATTY (6th, 2012), HSDB (Access on June 2016)). As for the classifications by other organizations, this substance is classified as "Carc. 2" (ECHA C&L Inventory (Access on August 2016)). Therefore, the substance was classified in Category 2. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - |
In a 3-generation reproductive toxicity study using rats administered in their diet, no reproductive or developmental toxicity was observed at a dose where a decrease in parental and pup body weights were observed (PATTY (6th, 2012), HSDB (Access on June 2016)). In two developmental toxicity studies using pregnant rats orally given during the organogenesis period, only slight effects (incomplete ossification, a decrease in fetal body weights) were observed in fetuses (PATTY (6th, 2012), HSDB (Access on June 2016)). From the above test results, it is possible to be classified as "Not classified" for this hazard class, however, it is described that delayed puberty was observed in a pubertal development study using female rats (PATTY (6th, 2012), HSDB (Access on June 2016)), and that neuroendocrine disrupter effect was concerned with this substance based on the alteration of serum LH (luteinizing hormone) and the change of estrous cycles and hormone responsive tissues (EPA TRED (2006)). Therefore, the substance was classified as "Classification not possible" for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. No single exposure data of this substance for humans are available. Besides, it is described that dizziness, saltatorial cramps, dyspnea and irregular respiration were observed after an oral administration of this substance in mice at 5,000 mg/kg which is above Category 2 (HSDB (Access in June 2016)). |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - |
No data available for humans. As for experimental animals, it is reported that in both a 56-day repeated dose toxicity study using rats by oral administration and a repeated dose toxicity study using rabbits administered orally for 1 to 4 months, the changes in hemoglobin were observed at the dose which is above Category 2 (PATTY (6th, 2012)), and that in a 90-day feeding repeated dose toxicity study using dogs, no toxicological signs were noted (PATTY (6th, 2012)). As above, there are not sufficient effects for classification. Also, no adverse information of other exposure routes was available. Therefore, the substance was classified as "Classification not possible." |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 1 |
 Warning |
H400 |
P273
P391 P501 |
From 14-day EC50 = 0.1 mg/L for an aquatic plant (Lemna gibba) (AQUIRE, 2016; HSDB, 2008), it was classified in Category 1. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 |
P273
P391 P501 |
If chronic toxicity data are used, then it is classified in Category 1due to being not rapidly degradable (BIOWIN), and 14-day NOEL = 0.022 mg/L for an aquatic plant (Lemna gibba) (AQUIRE, 2016). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (BIOWIN), and 14-day EC50 = 0.1 mg/L for an aquatic plant (Lemna gibba) (AQUIRE, 2016; HSDB, 2008). It was classified in Category 1 from the above results. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
|
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * 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. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |