NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	11054-70-9
Chemical Name	Lasalocid
Substance ID	R01-B-117
Classification year (FY)	FY2019
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
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

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	No data available.
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	No data available.
11	Self-heating substances and mixtures	*	- -	-	-	Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 3. [Evidence Data] (1) LD50 for rats (lasalocid sodium, CAS RN 25999-20-6): 122 mg/kg (a converted value equivalent to this substance: 118 mg/kg) (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LD50 for rabbits (lasalocid sodium, CAS RN 25999-20-6): 1,400 mg/kg (a converted value equivalent to this substance: 1,350 mg/kg) (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Though there were no data on this substance, data on the sodium salt of this substance were available. Based on (1), it was classified as "Not classified." [Evidence Data] (1) In a skin irritation test in which 500 mg of the sodium salt of this substance (lasalocid sodium, CAS RN 25999-20-6) was applied occlusively to the skin of rabbits for 4 hours, no irritation was observed (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Though there were no data on this substance, data on the sodium salt of this substance were available. Based on (1), it was classified in Category 2A. [Evidence Data] (1) In an eye irritation test in which 0.1 mL (0.036 g) of the sodium salt (lasalocid sodium, CAS RN 25999-20-6) of this substance was applied to rabbits, slight to moderate conjunctival redness was observed from 1 hour to 7 days after application, and transient conjunctival edema and corneal opacity were seen in some animals, but these were resolved after 14 days (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Though there were no data on this substance, data on the sodium salt of this substance were available. Based on (1), it was classified as "Not classified." [Evidence Data] (1) In a skin sensitization test (maximization method, intradermal induction: 1%) with guinea pig using the sodium salt of this substance (lasalocid sodium, CAS RN 25999-20-6), erythema was observed in both the administration group and the control group, but there was no difference between the two groups, and it was not considered to be sensitizing to the skin (Evaluation of effect for the food safety (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014))).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Though there were no data on this substance, data on the sodium salt of this substance were available. Based on (1), it was classified as "Not classified." [Evidence Data] (1) As for in vitro, negative results have been reported for the sodium salt of this substance (lasalocid sodium, CAS RN 25999-20-6) in a bacterial reverse mutation test, a forward mutation test and an unscheduled DNA synthesis test with cultured mammalian cells, and a chromosomal aberration test with human peripheral blood lymphocytes (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014), EMEA Summary Report (2004)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] There were no classification results by domestic and international organizations. There were no data reported on humans. Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) In a carcinogenicity study in which mice were given the sodium salt of this substance (CAS RN 25999-20-6) by feed for 2 years, no increase in the incidence of tumors associated with the treatment was observed (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)). (2) In a combined chronic toxicity/carcinogenicity study in which the sodium salt of this substance was administered by feed to rats for 1 week before mating, 2 weeks during mating, and throughout pregnancy and lactation period, and then weaned on postnatal Day 21 and selected weaned pups were administered by feed for 130 weeks, tumor incidence was similar in all groups and no carcinogenicity was seen (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)).
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Though there are no data on this substance, from the data for the sodium salt of this substance (CAS RN 25999-20-6) shown in (1) and (2), it was classified in Category 1B. Besides, the classification result was changed from the previous classification by the use of the new information sources. [Evidence Data] (1) In a three-generation reproductive toxicity study in which rats were given lasalocid sodium by feed, a decreased number of corpora lutea and a decreased number of implantations were observed at the dose where no effects were observed in maternal animals. At the dose where maternal toxicity (decreased body weight gain) was observed, decreased body weight gain, and decreased viability index during lactation were seen in offspring (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)). (2) In a developmental toxicity test in which female rabbits were given lasalocid sodium by gavage on gestational Day 6-28, embryo/fetotoxicity (increased early embryo mortality, lowered fetal weight, increased corneal opacity, maxillary and zygomatic bone fusion, increased incidence of malposition of the 13th extra ribs and pelvic girdle, incomplete ossification) was seen at the doses at which maternal toxicity was observed (decreased feces, lowered body weight, etc.) (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)).
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] There were no reports of single exposure to this substance in humans. As for experimental animals, there were reports on neurotoxicity as shown in (1). Although the details of the number of doses and the amount of dose were unknown, it was classified in Category 2 (nervous system) from the conservative safety viewpoint. The classification result was changed from the previous classification by the use of the new information sources. [Evidence Data] (1) It was reported that this substance acted as a neurotoxin through its effect on cation channels, and although the number of doses and the amount of dose were not described, effects on the nervous system, namely tremors, convulsions and a decrease in seizure threshold were reported in dogs (Evaluation of effect for the food safety (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014))). [Reference Data, etc.] (2) In a single dose oral toxicity test with rats, an LD50 value of lasalocid sodium (CAS RN 25999-20-6), the sodium salt of this substance, was 122 mg/kg (a converted value equivalent to this substance: 117 mg/kg, corresponding to Category 1), and as clinical signs, cyanosis and hypopnea were seen (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)). (3) An oral LD50 value of lasalocid sodium in horses was 21.5 mg/kg (a converted value equivalent to this substance: 20.7 mg/kg, corresponding to Category 1). As clinical signs, depression, ataxia, incomplete paralysis, paralysis, loss of appetite, and lateral position were seen. An effect on the cardiac muscle was significant (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)). (4) This substance has been used as a veterinary medicine or feed additive in overseas countries, and as a feed additive in Japan. It is not used as a human medicine. The European Medicines Agency (EMEA) judged that the neurotoxicity effects of this substance were not considered to present a significant risk in humans (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014), EMEA Summary Report (2004)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (central nervous system, heart, blood system)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Although there was no data on this substance, it was classified based on the information of lasalocid sodium (CAS RN 25999-20-6). Based on (1) and (2), the effects on the heart and blood system were observed within the range of Category 1, and based on (3)-(5), the effects on the central nervous system were observed within the range of Category 1, therefore, it was classified in Category 1 (central nervous system, heart, blood system). Conducting a review by use of new information sources, the classification result was changed from the previous classification. [Evidence Data] (1) In a 13-week repeated dose toxicity study with rats dosed by feed, lowered body weight and hemosiderin pigmentation of the liver at or above 5 mg/kg/day (a converted value equivalent to this substance: 4.8 mg/kg/day, within the range of Category 1), polychromatic erythrocytes, acanthocytes, codocytes, increases in ALP, ALT and AST, vacuolation of cells in the cardiac muscle, anterior pituitary and skeletal muscle, anterior pituitary and skeletal myocytes, hemosiderin pigmentation of the kidney at 20 mg/kg/day (a converted value equivalent to this substance: 19.3 mg/kg/day, within the range of Category 2) were observed (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)). (2) In a 13-week repeated dose toxicity study with weanling rats dosed by feed, decreased hematocrit value and neutrophilia at or above 2 mg/kg/day (a converted value equivalent to this substance: 1.9 mg/kg/day, within the range of Category 1), decreases in hemoglobin, codocytes, and absolute and relative heart weight, and increased hemosiderin pigmentation in the kidney and liver at or above 3 mg/kg/day (a converted value equivalent to this substance: 2.9 mg/kg/day, within the range of Category 1), decreased body weight gain, increase in ALP and AST, lowered absolute and relative lung weight, increased relative kidney weight, and vacuolation of myocardial cells at 10 mg/kg/day (a converted value equivalent to this substance: 9.6 mg/kg/day, within the range of Category 1) were observed (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)). (3) In a study in which male and female rats were dosed by feed and their offspring were dosed by feed at the same dose as their parents for 130 weeks after weaning, neurological findings (slow gripping or slow righting reflex), increased adrenal gland weight were seen at or above 35 ppm (a converted value equivalent to this substance: male/female: 1.7/2.1 mg/kg/day, Category 1) (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)). (4) In a 13-week repeated dose toxicity study with dogs dosed by gavage, vacuolation of hepatocytes at or above 2 mg/kg/day (a converted value equivalent to this substance: 1.9 mg/kg/day, within the range of Category 1), transient neurological changes (weakness of hind limb muscle, tremors, abnormal gait) that were seen in 4 out of 6 animals, and accompanied with decreased appetite, weight loss, and increased ALP, AST, and ALT in one animal at 10 mg/kg/day (a converted value equivalent to this substance: 9.6 mg/kg/day, within the range of Category 1) were observed (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)). (5) In a 2-year toxicity study with dogs dosed by feeding, intermittent paralysis of extremities in 5 animals in the treated group (recovered within 24 hours) and increased ALP (both sexes, after 6 months) were observed at 180 ppm (a converted value equivalent to this substance: 4.8 mg/kg/day, within the range of Category 1) (Risk Assessment Report (Veterinary medicinal products) (Food Safety Commission of Japan, 2014)). [Reference Data, etc.] (6) The European Medicines Agency (EMEA) has determined that the neurotoxicity effects of this substance were not considered to present a significant risk to humans (Risk Assessment Report (Veterinary medicinal products, Feed additives) (Food Safety Commission of Japan, 2014)).
10	Aspiration hazard	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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