GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 113-92-8
Chemical name Chlorpheniramine maleate
Substance ID 23A5052
Fiscal year of classification conducted FY2011
Classifier(s) (Ministries) Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
New/Revised New
Download in Excel format Excel file

REFERENCE INFORMATION

Item Information
Guidance used for classification (External link) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010)
Environmental Hazards: UN GHS Document (4th revised edition)
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

PHYSICAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(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 - - - "Solids" according to GHS definition.
3 Aerosols Not applicable - - - Not an aerosol product.
4 Oxidizing gases Not applicable - - - "Solids" according to GHS definition.
5 Gases under pressure Not applicable - - - "Solids" according to GHS definition.
6 Flammable liquids Not applicable - - - "Solids" according to GHS definition.
7 Flammable solids Classification not possible - - - No data.
8 Self-reactive substances and mixtures Classification not possible - - - There is a chemical group present in the molecule associated with a self-reactive property (unsaturated bond), but the classification is not possible due to no data.
9 Pyrophoric liquids Not applicable - - - "Solids" according to GHS definition.
10 Pyrophoric solids Classification not possible - - - No data.
11 Self-heating substances and mixtures Classification not possible - - - No established test method suitable for solid substances with a melting point of 140 degrees C or lower.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - "Solids" according to GHS definition.
14 Oxidizing solids Not applicable - - - It contains oxygen and chlorine which are not chemically bonded to elements other than carbon or hydrogen.
15 Organic peroxides Not applicable - - - An organic compound that does not contain -O-O- structure.
16 Corrosive to metals Classification not possible - - - No established test method suitable for solid substances.

HEALTH HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
1 Acute toxicity (Oral) Category 4

Warning
H302
P301+P312
P264
P270
P330
P501
It was classified in Category 4 to which most of the three LD50 data for rats (118 mg/kg, 540 mg/kg, 680 mg/kg (above NTP TR317 (1986)) correspond, one of which corresponds to Category 3 and two correspond to Category 4.
1 Acute toxicity (Dermal) Classification not possible - - - No data.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - No data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - No data.
2 Skin corrosion/irritation Classification not possible - - - No data.
3 Serious eye damage/eye irritation Classification not possible - - - No data.
4 Respiratory sensitization Classification not possible - - - No data.
4 Skin sensitization Classification not possible - - - No data.
5 Germ cell mutagenicity Not classified - - - From a negative result in a micronucleus test using bone marrow cells after intraperitoneal administration in mice (in vivo somatic cell mutagenicity test) (NTP DB (1993)), it was classified as "Not classified."
Besides, as in vitro tests, results of negatives in an Ames test (NTP DB (1982)) and a mouse lymphoma test (NTP DB (Access on May 2011)) and a positive in a chromosomal aberration test using CHO cells in the presence of metabolic activation (NTP DB (Access on May 2011)) were reported.
6 Carcinogenicity Not classified - - - In a 103-week oral administration test in rats and mice, it was reported that no evidence of carcinogenicity in either species of either sex was found, though decreased body weights in dosed groups and decreased survival rates in high-dose female rats and high-dose male mice at the end of the test were observed. (NTP TR317 (1986))
Therefore, it was classified as "Not Classified."
Besides, reduction of the sensitivity to detect a carcinogenic response due to high mortality in high-dose female rats and high-dose male mice, and proliferative changes by increased incidences of thyroid gland follicular cell cysts and hyperplasia in female mice were reported.
7 Reproductive toxicity Category 2

Warning
H361
P308+P313
P201
P202
P281
P405
P501
In an oral administration test using rats, in which males were dosed from 63 days before mating through a mating period, and females were dosed from 21 days before mating until day 14 of gestation or 21 days after parturition, no effects on sexual function and fertility, but an increased percentage of deaths in offspring during a lactation period were observed (NTP TR317 (1986)).
Furthermore, mice had 100% of abortion or resorption during a gestation period by oral administration in the highest dose group, and fetuses showed marked decreases in survival rate at the end of gestation or after delivery at doses lower than the highest. (NTP TR317 (1986))
Due to no description of general toxicity in parent animals, it was classified in Category 2 based on the above.
Besides, in an oral administration test during an organogenetic period in rats and rabbits, no adverse effects on the development of the offspring including teratogenicity were reported. (NTP TR317 (1986))
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system)

Danger
H370
P307+P311
P260
P264
P270
P321
P405
P501
This substance is used as an antihistamine medicine (H1 receptor antagonist), and the H1 receptor antagonist is known to cause excitement or depression of central nervous system. (NTP TR317 (1986))
Convulsions and confusions are listed as serious adverse effects, and sedation, nervousness, sleepiness, dizziness, tremor, coordination abnormality and so on are listed as other adverse effects in a neuropsychiatric system in the drug package insert. (Ethical pharmaceuticals (2010), corresponding to List 1)
And acute poisoning with H1 receptor antagonists, which show symptoms of hallucinations, excitement, ataxia, incoordination, athetosis, and convulsions, could cause very dangerous situations by their central nervous stimulation. (HSDB (2003))
From the above knowledge in human, it was classified in Category 1 (central nervous system).
Besides, also in experimental animals, excitement, muscle tremor, ataxia, and convulsive seizures were reported as symptoms in an acute toxicity test using rats and mice. (NTP TR317 (1986))
9 Specific target organ toxicity - Repeated exposure Category 1 (central nervous system, cardiovascular system, hematopoietic system)

Danger
H372
P260
P264
P270
P314
P501
This substance is used as an antihistamine medicine (H1 receptor antagonist), and the H1 receptor antagonist is known to cause excitement or depression of central nervous system. (NTP TR317 (1986))
Convulsions and confusions are listed as serious adverse effects, and sedation, nervousness, sleepiness, dizziness, tremor, coordination abnormality and so on are listed as other adverse effects in a neuropsychiatric system in the drug package insert. (Ethical pharmaceuticals (2010))
Besides, in animal tests, in oral administration in rats and mice for 2, 13, or 104 weeks, hyperactivity, hyperexcitability, and lethargy were observed, and convulsions, tremor, and loss of coordination in addition to deaths were reported at a high dose. (NTP TR317 (1986))
By taking as a target organ from the above results, it was classified in Category 1 (central nervous system).
In the second place, in 104-week oral administration in monkeys, decreased heart rates, and prolonged duration of electrical systole at 10 mg/kg/day corresponding to Category 1 in Guidance values or higher, and deaths by cardiac failure in addition to arrhythmias and fainting at 15 mg/kg/day occurred. (NTP TR317 (1986))
Serious adverse effects such as shock, cyanosis, dyspnea, angina pectoris, and hypotension are listed in medical use in humans. (Ethical pharmaceuticals (2010))
Therefore, it was classified in Category 1 (cardiovascular system).
There are case reports, moreover, that show association with thrombocytopenic purpura, bone marrow suppression, and aplastic anemia (NTP TR317 (1986)), and aplastic anemia and agranulocytosis are listed as serious adverse effects (Ethical pharmaceuticals (2010)).
Therefore it was classified in Category 1 (hematopoietic system).
From the above, it is classified in Category 1 (central nervous system, cardiovascular system, hematopoietic system).
10 Aspiration hazard Classification not possible - - - No data.

ENVIRONMENTAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible - - - No data.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - No data.
12 Hazardous to the ozone layer Classification not possible - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* 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.

Updated date:
  2017/3/17 Addition of Rationale for the classification

List of GHS Classification Results