Chemical Name：phenmedipham; methyl 3-(3-methylcarbaniloyloxy)carbanilate(ISO)
CAS：13684-63-4

Hazard class		Classification	Symbol	Signal word	Hazard statement	Precautionary statement	Rationale for the classification
1	Acute toxicity （Oral）	Not classified	-	-	-	-	Its rat LD50 values are > 8000 mg/kg (EHC 64 (1986), EPA RED (2005), HSDB (2003), (Pesticide Safety Information (Japan Crop Protection Association (1992)) (Test organization: Schering Co.)) and > 12800 mg/kg (Pesticide Safety Information (Japan Crop Protection Association (1992) (Test organization: Hokkaido Institute of Public Health)), both of which fall under "Not classified" category guidance values. In addition, its rat LD0 value is documented to be 12800 mg/kg (IUCLID (2000)). Based on these values, the substance was classified into "Not classified".
1	Acute toxicity （Dermal）	Not classified	-	-	-	-	Based on its rat and rabbit LD50 values of > 4000 mg/kg (EHC 64 (1986), EPA RED (2005)) and rat LD50 of > 2500 mg/kg (Pesticide Safety Information (Japan Crop Protection Association (1992)), the substance was classified into "Not classified" (Category 5 or "Not classified" category in the United Nations classification).
1	Acute toxicity （Inhalation: Gases）	Not applicable	-	-	-	-	Solid (GHS definition)
1	Acute toxicity （Inhalation: Vapours）	Classification not possible	-	-	-	-	No data available.
1	Acute toxicity （Inhalation: Dusts and mists）	Classification not possible	-	-	-	-	Its LC0 value is 7 mg/kg (IUCLID (2000), which indicates that the substance is to be placed in Category 5 or "Not classified" category. However, classification is not possible due to lack of other datasets.
2	Skin corrosion/irritation	Not classified	-	-	-	-	Based on the reports that skin irritation was not detected in rabbit tests (EPA RED (2005), IUCLID (2000) (OECD TG 404 GLP), (Pesticide Safety Information (Japan Crop Protection Association (1992)), the substance was classified into "Not classified".
3	Serious eye damage/eye irritation	Classification not possible	-	-	-	-	According to EPA RED (2005) and Pesticide Safety Information (Japan Crop Protection Association (1992)), the substance is not irritating, while based on the rabbit test (OECD TG 405 GLP) documented by the IUCLID (2000), the substance is described as follows: "Slightly irritating. Grade 1 conjunctival redness in all animals 1 hour post instillation. All eyes normal by 24 hours." Based on these descriptions, the substance was classified into the "Classification not possible" category.
4	Respiratory sensitization	Classification not possible	-	-	-	-	No data available.
4	Skin sensitization	Classification not possible	-	-	-	-	According to the IUCLID (2000), the guinea pig tests (OECD TG 406 GLP) found that substance was not sensitizing. In humans who used pharmaceutical product containing the substance for a long time (8 to 9 years), two likely cases of skin sensitization were reported (HSDB (2003)). However, in the maximization tests using guinea pigs that were treated with pharmaceutical product (13% emulsion) (the tests cited by both EPA RED (2005) and Pesticide Safety Information (Japan Crop Protection Association (1992)), the substance was documented to be not sensitizing. Since these documents do not provide sufficient evidence to deny skin sensitizing properties of the technical product, the substance was classified into "Classification not possible".
5	Germ cell mutagenicity	Not classified	-	-	-	-	Since in vivo mutagenicity tests (micronucleus tests using mouse bone marrow cells) (IUCLID (2000)) gave negative results, the substance was classified into "Not classified". As for in vitro tests, some of Ames tests gave positive results (NTB DB (accessed in December 2008)).
6	Carcinogenicity	Not classified	-	-	-	-	Based on negative results obtained in mixed diet tests using rats or mice (IUCLID (2000)) and other diet tests using rats or dogs (HSDB (2003)), the substance was classified into "Not classified".
7	Reproductive toxicity	Not classified	-	-	-	-	In 3-generation rat tests documented by the IRIS (2003), IUCLID (2000) or Pesticide Safety Information (Japan Crop Protection Association (1992)), clear reproductive toxicity was not recognized. Thus, the substance was classified into "Not classified". In addition, in rat or rabbit tests documented by the IUCLID (2000) (OECD TG 414 GLP), no effects on development of embryos or fetuses were detected, while decreased food consumption was observed in animal groups treated with highest doses (1350 mg/kg or 1000 mg/kg). According to Pesticide Safety Information (Japan Crop Protection Association (1992)), no teratogenic effects were found in embryos or fetuses in the study using rabbits.
8	Specific target organ toxicity - Single exposure	Classification not possible	-	-	-	-	In the single inhalation tests (7 mg/kg (dust)) (OECD TG 403 GLP), the administration temporarily affected posture and walking (IUCLID (2000)). In the oral administration tests using mice that were applied with 50 to 500 mg/kg, no effects of the administration were detected (Pesticide Safety Information (Japan Crop Protection Association (1992)). Despite these studies, classification is not possible due to insufficient data available.
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood system)		Warning	H373: May cause damage to organs through prolonged or repeated exposure (blood system)	P260: Do not breathe dust/fume/gas/mist/vapours/spray. P314: Get medical advice/attention if you feel unwell. P501: Dispose of contents/container to ...	In the 90-day mixed diet tests using rats that were applied with 2.5 to 250 mg/kg, slight anaemia, increased reticulocytes, changes in biochemical values, deposition of haemosiderin in the spleen, or increased haematopoiesis in the bone marrow were observed; and its LOAEL value was 500 ppm (25 mg/kg) (IUCLID (2000)). In addition, in 8-week mixed diet tests using mice that were treated with 150 to 2250 mg/kg, the effects on the blood system (anaemia, methaemoglobinaemia, haemosiderosis, prominent splenic germinal centres and increased hepatic extramedullary haemopoiesis) were observed; and its LOAEL value was 1000 ppm (150 mg/kg; 90-day correction: 93 mg/kg) (IUCLID (2000)). Based on these results, the substance was classified into Category 2 (blood system).
10	Aspiration hazard	Classification not possible	-	-	-	-	No data available.

Hazard class		Classification	Symbol	Signal word	Hazard statement	Precautionary statement	Rationale for the classification
11	Hazardous to the aquatic environment （Acute）	Category 1		Warning	H400: Very toxic to aquatic life	P273: Avoid release to the environment. P391: Collect spillage. P501: Dispose of contents/container to ...	Since its 96h ErC50 = 0.13 mg/L for algae (Scenedesmus) (IUCLID 2000), the substance was classified into Category 1.
11	Hazardous to the aquatic environment （Long-term）	Category 1		Warning	H410: Very toxic to aquatic life with long lasting effects	P273: Avoid release to the environment. P391: Collect spillage. P501: Dispose of contents/container to ...	Since its classification for acute toxicity is Category 1 and it is not rapidly degradable (OECD TG 302C, 28-day degradability = 39.5% (IUCLID 2000)), the substance was classified into Category 1.