Hazard class
|
Classification
|
Symbol
|
Signal word
|
Hazard statement
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Precautionary statement
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Rationale for the classification
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1
|
Acute toxicity (Oral)
|
Not classified
|
-
|
-
|
-
|
-
|
Based on LD50 values of approximately 5000 mg/kg (ACGIH (2001)) and 5000 - 7000 mg/kg (NTP TR435 (1994)) for rats, the substance was classified into "Not classified".
|
1
|
Acute toxicity (Dermal)
|
Classification not possible
|
-
|
-
|
-
|
-
|
No data available.
|
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
|
-
|
-
|
-
|
-
|
No data available.
|
2
|
Skin corrosion/irritation
|
Classification not possible
|
-
|
-
|
-
|
-
|
No data available.
|
3
|
Serious eye damage/eye irritation
|
Classification not possible
|
-
|
-
|
-
|
-
|
No data available.
|
4
|
Respiratory sensitization
|
Classification not possible
|
-
|
-
|
-
|
-
|
No data available.
|
4
|
Skin sensitization
|
Classification not possible
|
-
|
-
|
-
|
-
|
There is a report of positive responses in patch tests for 2 patients with contact dermatitis caused by rubber gloves which contain this substance (ACGIH (2001)). No additional care reports are not available. Classification was not possible due to lack of data.
|
5
|
Germ cell mutagenicity
|
Classification not possible
|
-
|
-
|
-
|
-
|
Classification not possible due to lack of data from in vivo mutagenicity tests. From in vitro mutagenicity tests, there are reports of a negative Ames test and a negative CHO cell chromosomal aberration test ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2006), ACGIH (2001)).
|
6
|
Carcinogenicity
|
Not classified
|
-
|
-
|
-
|
-
|
Based on the classification of "A4" in ACGIH (ACGIH-TLV (2005)), the substance was classified as "Not classified". In 2-year feeding tests in rats and mice, there was no evidence of carcinogenic activity in either species (NTP TR435 (1994)).
|
7
|
Reproductive toxicity
|
Classification not possible
|
-
|
-
|
-
|
-
|
Although there is a report that by oral administration to pregnant mice during organogenesis period, the substance caused maternal mortality and a decreased rate of survival of pups, but had no effect on the number of viable litters, litter size, pup birth weight, or pup weight gain (NTP TR435 (1994)), test details are unknown. Classification not possible due to a lack of sufficient data.
|
8
|
Specific target organ toxicity - Single exposure
|
Classification not possible
|
-
|
-
|
-
|
-
|
Although there is a report that in acute oral toxicity tests in rats, the LD50 value is between 5000 and 7000 mg/kg and the rats exhibited severe diarrhea preceding death (NTP TR435 (1994)), classification was not possible due to lack of sufficient data.
|
9
|
Specific target organ toxicity - Repeated exposure
|
Category 2 (liver)
|
|
Warning
|
H373: May cause damage to organs through prolonged or repeated exposure (liver)
|
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 a 28-day repeated oral dose test in rats, effects on the intestine were observed at dose levels of 60 mg/kg/day and higher. Effects on the liver were noted at a dose level of 250 mg/kg/day (90-day equivalence: 77.8 mg/kg/day) ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (2006)). In 13-week and 2-year feeding tests in rats and mice (NTP TR435 (1994)), the following effects were observed: increased serum hepatic enzymes, ALP and GOT levels; histopathological finding in the liver including hypertrophy of Kupffer cells, bile duct hyperplasia, and individual cell necrosis of hepatocytes; hematological changes in erythrocyte count, hemoglobin concentration and hematocrit level; pigmentation and degeneration of the renal cortical tubule epithelial cells; and increase in size and number of macrophages in the mesenteric lymph nodes. These findings were observed at high dose levels exceeding the upper limit of the guidance value range. The effects on the kidney were reported in some tests only, but the effects on the liver were observed in all 5 tests including the 28-day oral test in rats. In the 2-year feeding test in rats, histopathological changes including Kupffer cell hypertrophy, hepatocyte cytoplasmic vacuolization, mixed cell foci, and basophilic foci and remarkable increase in serum GOT were observed at 2500 ppm (100 - 120 mg/kg/day). It is reported that the increases in ALP at dose levels of 1000 ppm (40 - 45 mg/kg/day) and higher are indicative of disturbances involving the hepatobiliary system (NTP TR435 (1994)). Based on the data, the substance was classified into Category 2 (liver).
|
10
|
Aspiration hazard
|
Classification not possible
|
-
|
-
|
-
|
-
|
No data available.
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