Item | Information |
---|---|
CAS RN | 97-99-4 |
Chemical Name | Tetrahydrofurfuryl alcohol |
Substance ID | R03-C-068-MHLW |
Classification year (FY) | FY2021 |
Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW) |
New/Revised | Revised |
Classification result in other fiscal year | FY2008 |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
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 |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
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1 | Explosives | - |
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2 | Flammable gases | - |
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3 | Aerosols | - |
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4 | Oxidizing gases | - |
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- | - | - |
5 | Gases under pressure | - |
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- | - | - |
6 | Flammable liquids | - |
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- | - | - |
7 | Flammable solids | - |
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- | - | - |
8 | Self-reactive substances and mixtures | - |
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9 | Pyrophoric liquids | - |
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- | - | - |
10 | Pyrophoric solids | - |
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- | - | - |
11 | Self-heating substances and mixtures | - |
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- | - | - |
12 | Substances and mixtures which, in contact with water, emit flammable gases | - |
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13 | Oxidizing liquids | - |
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- | - | - |
14 | Oxidizing solids | - |
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15 | Organic peroxides | - |
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- | - | - |
16 | Corrosive to metals | - |
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- | - | - |
17 | Desensitized explosives | - |
- |
- | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
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1 | Acute toxicity (Oral) | - |
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- | - | - |
1 | Acute toxicity (Dermal) | - |
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- | - | - |
1 | Acute toxicity (Inhalation: Gases) | - |
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- | - | - |
1 | Acute toxicity (Inhalation: Vapours) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Dusts and mists) | - |
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- | - | - |
2 | Skin corrosion/irritation | - |
- |
- | - | - |
3 | Serious eye damage/eye irritation | - |
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4 | Respiratory sensitization | - |
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4 | Skin sensitization | - |
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5 | Germ cell mutagenicity | - |
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6 | Carcinogenicity | - |
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- | - | - |
7 | Reproductive toxicity | Category 1B |
Danger |
H360 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1), at the dose at which general toxicity effects were observed in parental animals, adverse effects on fertility and reproductive function as well as embryotoxicity/fetotoxicity were observed. Based on (2), at the dose at which no maternal toxicity was observed, although not significant statistically, external malformation (filamentous tail) was observed. In addition, total early resorptions were observed at the dose one step higher than the dose at which no serious toxicity was observed in maternal body. Accordingly, since developmental effects were observed at the dose at which no maternal toxicity was observed, it was classified in Category 1B. Based on the new information source, the category was changed. [Evidence Data] (1) In a reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 421, GLP, administration period: males: a total of 47 days beginning 14 days before mating, females: 42 to 52 days beginning 14 days before mating to day 4 of lactation), at the high dose (150 mg/kg/day) at which systemic toxicity effects (such as reduced body weight gain, decreased food consumption, increased/reduced locomotor activity, capsule inflammation in the spleen) were caused in parental animals, a trend towards prolonged estrous cycles, prolonged gestation length, and decreased delivery index were observed, and marked decreases in the number of pups born and live birth index (only 4 live pups per litter on postnatal day 4) were observed in pups born. Furthermore, at the highest dose (500 mg/kg/day), effects on the testes and epididymides in males (a decrease in weight, seminiferous tubular atrophy and hyperplasia of interstitial cells in the testes, decreased sperm in the lumen of epididymides, etc.) and prolonged estrous cycles in females were observed. At this dose, no maternal animals delivered their offspring, and at necropsy, complete embryonic death and early embryonic resorption were observed in all maternal animals (Toxicity Testing Results for Existing Chemical Substances under the Chemical Substances Control Law (year unknown), SIAR (2005), CLH Report (2011), AICIS (previous NICNAS) IMAP (2018)). (2) In a range finding developmental toxicity study with female rats dosed by gavage (n=8 animals/group, 5 doses from 10 to 1,000 mg/kg/day, days 6 to 15 of gestation), reduced body weight gain and decreased food consumption were observed at or above 500 mg/kg/day and systemic symptoms (impaired mobility, decreased muscle tone, absence of pain response) were additionally observed at 1,000 mg/kg/day in maternal animals. As for developmental effects, a decrease in fetal weight and an increased incidence of tail anomaly (filamentous tail) were observed (4/8 litters, 5/124 fetuses: no statistically-significant difference) at 100 mg/kg/day at which no maternal toxicity was observed, and total early resorptions were observed at or above 500 mg/kg/day (SIAR (2005), CLH Report (2011)). [Reference Data, etc.] (3) The ECHA RAC (Committee for Risk Assessment of the European Chemicals Agency) concluded that, based on some evidence for effects on pregnancy outcome and parturition and testicular toxicity in (1), classification in Category 2 for fertility and reproductive function was justified, and based on total early resorptions and fetotoxicity in (2), it fulfilled the criteria for Category 1B (ECHA RAC Opinion (2012)). (4) In the EU, it was classified in Repr. 1B (EU-CLP Classification Results (Accessed Dec. 2021)). |
8 | Specific target organ toxicity - Single exposure | - |
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9 | Specific target organ toxicity - Repeated exposure | - |
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10 | Aspiration hazard | - |
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- | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
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11 | Hazardous to the aquatic environment Short term (Acute) | - |
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- | - | - |
11 | Hazardous to the aquatic environment Long term (Chronic) | - |
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12 | Hazardous to the ozone layer | - |
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- | - | - |
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