GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 6915-15-7
Chemical name DL-Malic acid
Substance ID 23A5137
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 Not applicable - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable - - - "Solids" according to GHS definition.
10 Pyrophoric solids Not classified - - - It is conceivable that it does not ignite at normal temperatures from an ignition point of 340 degrees C (MSDS (Sigma-Aldrich) (Access on Sep. 2011)).
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 - - - An organic compound does not contain fluorine or chlorine but contains oxygen which is 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) Not classified - - - From an LD50 value of >3200 mg/kg bw for rats (PATTY (5th, 2001)), it was classified as "Not classified" in JIS classification (Category 5 or "Not classified" in UN GHS classification).
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 Category 2

Warning
H315
P302+P352
P332+P313
P264
P280
P321
P362
On the basis of moderately irritating reported as a result of a test applied 20 mg or 500 mg to rabbit skin for 24 hours (PATTY (5th, 2001)), 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 of severe irritation reported as a result of a test applied 750 micro g to rabbit eyes (PATTY (5th, 2001)), 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 Classification not possible - - - The classification is not possible due to no in vivo test data.
Besides, both an Ames test (PATTY (5th, 2001)) and a chromosomal aberration test using Chinese hamster fibroblast cells (PATTY (5th, 2001)) reported negatives in in vitro tests.
6 Carcinogenicity Classification not possible - - - No data.
7 Reproductive toxicity Classification not possible - - - An oral administration test during gestation including an organogenetic period in rats and mice (rats: up to 350 mg/kg/day, mice: up to 266 mg/kg/day) reported neither general toxicity in maternal animals, fetal toxicity, nor teratogenicity (HPVIS (Access on Sep. 2011), corresponding to List 2).
But it was classified as "Classification not possible" due to no information on the effects on sexual function and fertility.
8 Specific target organ toxicity - Single exposure Classification not possible - - - No data.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - As a result of a 2-year diet administration test in rats (doses 25, 250, 2500 mg/kg bw/day), no tissue abnormalities or changes in the blood or urine, but only changes in organ weights, a decrease in growth, and hunched posture in the first year at a dose of 2500 mg/kg above the upper limit in Guidance values were observed.
Therefore, it corresponds to "Not classified" in oral administration.
But the data are from List 2 and effects in other routes are unknown.
Therefore, it was classified as "Classification not possible" in specific target organ toxicity (repeated exposures) due to lack of data.
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:
* 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:
2016/11/30 Addition of Rationale for the classification

List of GHS Classification Results