GHS Classification Result

日本語で表示

GENERAL INFORMATION

Item Information
CAS number 26530-20-1
Chemical name 2-n-Octyl-4-isothiazolin-3-one
Substance ID 23A5101
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 - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
3 Aerosols Not applicable - - - Not an aerosol product.
4 Oxidizing gases Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
5 Gases under pressure Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
6 Flammable liquids Classification not possible - - - No data.
7 Flammable solids Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
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 Classification not possible - - - No data.
10 Pyrophoric solids Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
11 Self-heating substances and mixtures Classification not possible - - - No established test method suitable for liquid substances.
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 - - - An organic compound that contains oxygen which is not chemically bonded to elements other than carbon.
14 Oxidizing solids Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
15 Organic peroxides Not applicable - - - An organic compound that does not contain -O-O- structure.
16 Corrosive to metals Classification not possible - - - No data.

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
 All reported seven LD50 values for rats (708 mg/kg, 562 mg/kg, 794 mg/kg, 681 mg/kg, 735 mg/kg, 355 mg/kg, 358 mg/kg) (DFGMAK-Doc. 16 (2001)) correspond to Category 4.
1 Acute toxicity （Dermal） Category 3

Danger
 H311
 P302+P352
P280
P312
P322
P361
P363
P405
P501
 Because the higher hazard category between two reported LD50 values for rabbits (311 mg/kg and about 1800 mg/kg) (DFGMAK-Doc. 16 (2001)) which correspond to Category 3 and Category 4 was adopted, it was classified in Category 3.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - It is a liquid at normal temperatures (Merck (14th, 2006)).
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - No data.
1 Acute toxicity （Inhalation: Dusts and mists） Category 3

Danger
 H331
 P304+P340
P403+P233
P261
P271
P311
P321
P405
 From an LC50 value of 0.586 mg/L/4h for rats (DFGMAK-Doc. 16 (2001)), it was classified in Category 3.
Besides, a reference value of mists was applied because exposure to an aerosol was described (DFGMAK-Doc. 16 (2001)).
2 Skin corrosion/irritation Category 1

Danger
 H314
 P301+P330+P331
P303+P361+P353
P305+P351+P338
P304+P340
P260
P264
P280
P310
P321
P363
P405
P501
 From severe erythema and edema accompanied by scab formation and tissue damage, a maximal score of 8.0, and "corrosive" classification in a test applied 0.5 mL of a 45 to 50% solution in propylene glycol to rabbit skins for 4 hours (DFGMAK-Doc. 16 (2001)), it was classified in Category 1.
3 Serious eye damage/eye irritation Category 1

Danger
 H318
 P305+P351+P338
P280
P310
 From severe irritation to the conjunctiva, cornea, and iris persisted for longer than 7 days and "corrosive" classification in a test applied 0.1 mL of a 45% solution into rabbit conjunctival sac (DFGMAK-Doc. 16 (2001)), it was classified in Category 1.
Besides, this substance is also classified as a corrosive substance to skins.
4 Respiratory sensitization Classification not possible - - - No data.
4 Skin sensitization Category 1A

Warning
 H317
 P302+P352
P333+P313
P261
P272
P280
P321
P363
P501
 A maximization test in guinea pigs concluded from a positive rate of 25% (5/20) in a 0.2% solution, 35% (7/20) in a 0.1% solution on day 21 provocation after induction, and 40% (8/20) in a 0.1% solution on day 35 that it is a moderately sensitizing substance. (DFGMAK-Doc. 16 (2001))
On the other hand, there are many reports as follow:
A case of a person who developed an allergic reaction to occupational exposure had a positive in a patch test. (DFGMAK-Doc. 16 (2001))
A case of a patient with eczema who had a positive in a patch test to this substance or a substance including this substance. (DFGMAK-Doc. 16 (2001))
A case where provocation caused allergic reactions in human subjects in a cumulative patch test. (DFGMAK-Doc. 16 (2001))
Furthermore, it is listed as a sensitizing substance in Contact Dermatitis (Frosch) (Contact Dermatitis (Frosch) (4th, 2006), corresponding to List 1).
From the above, it is classified in Category 1A because high frequent human cases were reported and 35 to 40% of animals responded to the concentration of 0.1% in the maximization test in guinea pigs.
5 Germ cell mutagenicity Not classified - - - It was classified as "Not classified" due to a negative without the increase of structural chromosomal aberrations in a chromosome aberration test using rat bone marrow (in vivo somatic cell mutagenicity test) (DFGMAK-Doc. 16 (2001)).
Besides, as in vitro tests, a negative in an Ames test, a positive in a chromosome aberration test using CHO cells, and a negative in an HPRT gene mutation test using CHO cells were reported respectively (DFGMAK-Doc. 16 (2001)).
6 Carcinogenicity Classification not possible - - - Lack of data.
Besides, in an 18-month diet administration test in mice, it is reported that incidences of lymphosarcomas, liver cell carcinomas, fibroadenomas, and pulmonary adenomas observed in a high-dose group at 1000 ppm did not differ from that of spontaneous neoplasms in a control group (DFGMAK-Doc. 16 (2001)).
But the classification is not possible due to no other data.
7 Reproductive toxicity Classification not possible - - - In oral administration tests in rats and rabbits during an organogenetic period, a decreased weight gain as general maternal toxicity was observed. But neither clear evidence of fetal toxicity nor adverse effects on the development of the offspring in both species except a slight increase in early resorptions not accompanied by post-implantation losses in a high dose in rats were reported. (DFGMAK-Doc. 16 (2001))
But, it was classified as "Classification not possible" due to lack of data on effects on sexual function and fertility in parent animals.
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, respiratory system)

Danger
 H370
 P307+P311
P260
P264
P270
P321
P405
P501
 In an oral administration test in rats, decreased activity at doses of 31.6 mg/kg and more, ataxia at 316 mg/kg and more, and losses of righting reflex at 1000 mg/kg and more were observed. And in another test, CNS depression and a hunched posture at 500 mg/kg and more, and tremor and prostration at 1000 mg/kg and more were observed.
On the other hand, apathy, ataxia, prostration, and partial paresis of the hind limbs at 291 mg/kg and more in dermal administration to rabbits, and CNS depression symptoms such as ataxia, prostration, and apathy at 94 mg/m3 and more in inhalation administration (mist) to rats were reported. (DFGMAK-Doc. 16 (2001))
From the above, it was classified in Category 1 (central nervous system) because symptoms occurred within a dose range of Category 1 in Guidance values.
Furthermore, in an inhalation administration test, dyspnea, bradypnea, and breathing noises were observed at 58 mg/m3/4h (mist) and more, and the lung changes at 229 to 671 mg/m3/4h in a gross pathological examination as the only finding significantly different from the historical control values were described. (DFGMAK-Doc. 16 (2001))
Therefore it was classified in Category 1 (respiratory system).
9 Specific target organ toxicity - Repeated exposure Category 1 (respiratory tract)

Danger
 H372
 P260
P264
P270
P314
P501
 Because in a 90-day inhalation exposure test (6 hours/day) (0.05, 0.64 and 6.39 mg/m3 (mist)) using rats, dyspnea, bradypnea, secretory cell hyperplasia of the septal mucosa, neutrophilic infiltration of the mucosa, squamous metaplasia of the respiratory epithelium, intraepithelial droplets in the nasal cavity were observed (DFGMAK-Doc. 16 (2001)) in a high-dose group at 6.39 mg/m3 corresponding to a range of Category 1 in Guidance values, it was classified in Category 1 (respiratory tract).
Neither dose-related effects in 90-day diet administration in rats up to a dose of 115 mg/kg bw/day (DFGMAK-Doc. 16 (2001)) nor apparent dose-related changes in necropsy and a pathological test in 90-day dermal administration in rats up to a dose of 14.87 mg/kg/day except occasional changes in blood and biochemical tests (DFGMAK-Doc. 16 (2001)) were reported.
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） Category 1

Warning
 H400
 P273
P391
P501
 It was classified in Category 1 from 96-hour LC50 = 0.047 mg/L for fish (Oncorhynchus mykiss) (U.S. EPA: RED, 2007).
11 Hazardous to the aquatic environment （Long-term） Category 1

Warning
 H410
 P273
P391
P501
 It was classified in Category 1 due to lack of rapid degradability (BIOWIN) and MATC = 0.012 mg/L in an early life stage test (ELS) for fish (Pimephales promelas) (U.S. EPA: RED, 2007).
12 Hazardous to the ozone layer Classification not possible - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* Hazard statement or Precautionary statement will show when hovering the mouse over a code of Hazard statement or Precautionary statement.
   Hazard statement and 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:
  2017/1/30 Addition of Rationale for the classification

List of GHS Classification Results