GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 62476-59-9
Chemical name Acifluorfen sodium salt
Substance ID 23A5116
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 Classification not possible - - - There is a chemical group associated with explosive properties (N-O) present in the molecule, but the classification is not possible due to no data.
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 - - - There is the information that "this chemical is a combustible solid but does not easily ignite" (HSDB (2010)), but the classification is not possible due to no data.
8 Self-reactive substances and mixtures Classification not possible - - - There is a chemical group associated with explosive properties (N-O) present in the molecule, but the classification is not possible due to no data.
9 Pyrophoric liquids Not applicable - - - "Solids" according to GHS definition.
10 Pyrophoric solids Not classified - - - It is classified as "Not classified" from the information that "this chemical is a combustible solid but does not easily ignite" (HSDB (2010)).
11 Self-heating substances and mixtures Classification not possible - - - No data.
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified - - - It contains a metal (Na), but it is conceivable that it does not react vigorously with water from data on water solubility as 0.405 g/L (USEPA/HPV (2001)).
13 Oxidizing liquids Not applicable - - - "Solids" according to GHS definition.
14 Oxidizing solids Classification not possible - - - An organic compound contains oxygen, and that is chemically bonded to elements other than carbon or hydrogen (N, Na), but the classification is not possible due to no data.
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 3

Danger
H301
P301+P310
P264
P270
P321
P330
P405
P501
On the basis of an LD50 value of 122 mg/kg bw for rats (USEPA/HPV (2001), corresponding to List 1), it was classified in Category 3.
1 Acute toxicity (Dermal) Category 4

Warning
H312
P302+P352
P280
P312
P322
P363
P501
On the basis of an LD50 value of 1457 mg/kg bw for rabbits (USEPA/HPV (2001)), it was classified in Category 4.
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 - - - An LC50 value of >1.38 mg/L/4h for rats was reported (USEPA/HPV (2001)), but it was classified as "Classification not possible" because the category cannot be determined.
Besides, a reference value of dust was applied because there is the information of "exposure to aerosol" in the reference.
2 Skin corrosion/irritation Category 2

Warning
H315
P302+P352
P332+P313
P264
P280
P321
P362
There is the information that "it was moderately irritating to skin in a test using rabbits" (Evaluation of effect for the food safety (2010)), and moderate erythema and slight edema were observed at doses of 3540 to 5000 mg/kg in a rabbit acute dermal toxicity test (USEPA/HPV (2001)), therefore, it was classified in Category 2.
3 Serious eye damage/eye irritation Category 2A

Warning
H319
P305+P351+P338
P337+P313
P264
P280
On the basis that "it was severely irritating to eyes in a test using rabbits" (Evaluation of effect for the food safety (2010)), it was classified in Category 2A.
4 Respiratory sensitization Classification not possible - - - No data.
4 Skin sensitization Classification not possible - - - No data.
5 Germ cell mutagenicity Not classified - - - On the basis of a negative result in a chromosomal aberration test using bone marrow cells after oral administration to mice (in vivo somatic cell mutagenicity test) (OECD TG475, GLP) (USEPA/HPV (2001)), it was classified as "Not classified."
Besides, a weakly positive in TA100 (+S9) in an Ames test (Evaluation of effect for the food safety (2010)) and a negative in a chromosomal aberration test in the absence of metabolic activation using CHO cells (USEPA/HPV (2001)) were reported as in vitro tests.
6 Carcinogenicity Classification not possible - - - Carcinogenicity in a 2-year combined chronic toxicity test with carcinogenicity test by diet administration in rats was not observed (Evaluation of effect for the food safety (2010)). But an increase in an incidence of liver tumors and forestomach papilloma in males and females in an 18-month diet administration carcinogenicity test in mice and an increase in a frequency of liver tumors in females in a 2-year carcinogenicity test in mice were observed respectively (Evaluation of effect for the food safety (2010)).
However, an evaluation by the Food Safety Commission concluded from a contribution of enzyme induction to a generation mechanism of liver tumors formation in mice and the high possibility that irritation by this substance caused forestomach papilloma that a generation mechanism of these tumors is unlikely genetic toxicity (Evaluation of effect for the food safety (2010)).
Therefore, it was classified as "Classification not possible" due to lack of data.
7 Reproductive toxicity Category 2

Warning
H361
P308+P313
P201
P202
P281
P405
P501
A two-generation reproduction toxicity test by diet administration in rats reported that observed general toxicity effects in parent animals were decreased body weight in the highest dose group (2500 ppm) in each generation, and decreased food consumption at 500 ppm or higher in F0 generation, and reproductive toxicity effects were decreased number of implantations sites at 2500 ppm in F0 generation and decreased pup viability on day 1 to 4 postpartum at 500 ppm or higher in F1 generation (USEPA/HPV (2001)).
Furthermore, in a development toxicity test by oral administration on day 6 to 19 of gestation in rats reported that decreased weights and 3 deaths out of 25 animals were observed in female parent animals in the highest dose group (180 mg/kg), increased resorptions at 180 mg/kg, and a fetal visceral abnormality (slight dilatation of the lateral ventricles of the brain) at 90 mg/kg or higher were observed (USEPA/HPV (2001)).
From the above results, it was classified in Category 2 because adverse effects on reproduction were observed at the dose where the general toxicity in parent animals occurred.
8 Specific target organ toxicity - Single exposure Category 1 (systemic toxicity), Category 3 (respiratory tract irritation)


Danger

Warning
H370
H335
P307+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
Oral administration to rats showed symptoms of lethargy, prostration, and ataxia at doses of 200 and 400 mg/kg which are above an LD50 value (122 mg/kg), and dermal administration to rabbits (an LD50 value: 1457 mg/kg) showed symptoms of lethargy, ataxia, shallow respiration, and prostration at doses of 990 to 1980 mg/kg (USEPA/HPV (2001)).
Specifying target organs from the above symptoms is difficult. But the doses in the above oral administration are within a range of Category 1 in guidance values and death occurred. Therefore it was classified in Category 1 (systemic toxicity).
Furthermore, an inhalation exposure of 0.52 to 1.38 mg/L (an LC50 value > 1.38 mg/L) (dust) to rats showed nasal discharge, dyspnea, and crusty nose (USEPA/HPV (2001)), therefore, it was classified in Category 3 (respiratory tract irritation).
9 Specific target organ toxicity - Repeated exposure Category 2 (liver)

Warning
H373
P260
P314
P501
On the basis that a rat 90-day diet administration test showed histopathological findings such as increased liver cell hypertrophy, liver tissue damage, mitotic figures, and increased proliferation of oval cells and bile duct, in addition to elevated alkaline phosphatase and transaminase at the highest dose of 5000 ppm (components of this substance 84 to 93 mg/kg/day) (USEPA/HPV (2001)), it was classified in Category 2 (liver).
Besides, observed hematological changes such as lower red blood cell counts and a hemoglobin value were not used as bases for classification due to no related histopathological effects.
Furthermore, a 21-day dermal administration test in rabbits, which showed severe dermal irritation with eschar formation dose-dependently along with symptoms such as nasal discharge, hair loss, soft stool, tremors, and decreased activity at 92 to 923 mg/kg/day (converted to a 90-day equivalent value: 21.5 to 215 mg/kg/day) (USEPA/HPV (2001)), did not report clear toxic effects within a range in guidance values.
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 is classified in Category 1 from EC50 = 378 ppb for an aquatic plant (Lemnoideae) (U.S. EPA: RED, 2004).
11 Hazardous to the aquatic environment (Long-term) Category 1

Warning
H410
P273
P391
P501
Reliable chronic toxicity data are not obtained.
Because appropriate data on rapid degradability was not obtained and it was classified in Category 1 in acute toxicity, it was classified in Category 1.
12 Hazardous to the ozone layer Classification not possible - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* 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:
2016/8/17 Addition of Rationale for the classification

List of GHS Classification Results