GHS Classification Result

Chemical Name:1,3,5-trioxan
CAS:110-88-3

Result:
ID: 12
Classifier: Ministry of Economy, Trade and Industry (METI)
Year Classified: FY2007
Reference Manual: GHS Classification Manual (10 Feb, 2006)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives - - - - - -
2 Flammable gases (including chemically unstable gases) - - - - - -
3 Aerosols - - - - - -
4 Oxidizing gases - - - - - -
5 Gases under pressure - - - - - -
6 Flammable liquids - - - - - -
7 Flammable solids - - - - - -
8 Self-reactive substances and mixtures - - - - - -
9 Pyrophoric liquids - - - - - -
10 Pyrophoric solids - - - - - -
11 Self-heating substances and mixtures - - - - - -
12 Substances and mixtures which, in contact with water, emit flammable gases - - - - - -
13 Oxidizing liquids - - - - - -
14 Oxidizing solids - - - - - -
15 Organic peroxides - - - - - -
16 Corrosive to metals - - - - - -

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - GESTIS (2003) indicates that "LD50 value of two or more rats fall between 8,190 mg/kg and 9,500 mg/kg" and Review of Toxicological Literature (s-Trioxane, 1999), which is a document of NTP, indicates that LD50 value of rats is 5,000 mg/kg. Based on 6,010 mg/kg obtained by application of the formula to these three values (8,190, 9,500, and 5,000 mg/kg), it is classified into "Not classified".
1 Acute toxicity (Dermal) Not classified - - - - Since the data of rat LD50 value 10,000 mg/kg is indicated in Review of Toxicological Literature (second-Trioxane, 1999) which is a document of NTP, it was classified into "Not classified".
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Since it was a solid by the definition of GHS, it was classified into "Not applicable".
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - In addition, EU classification is Xn; R20 (EU-Annex I). Although it is written in Review of Toxicological Literature (second-Trioxane, 1999) which is a document of NTP that saturated vapor pressure level is 17,100 ppm, and rat LC50 value is <7,057 ppm, classification is not possible since LC50 value cannot be specified.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - - Classification not possible due to lack of data
2 Skin corrosion/irritation Not classified - - - - Since GESTIS states, "Most studies of rabbits including studies in line with OECD Test Guidlines did not observe irritation," it was classified into "Not classified".
3 Serious eye damage/eye irritation Not classified - - - - GESTIS (2003) describes as "When the various tests employing "rabbits were summarized, it was slightly stimulative" and since this expression corresponds to "Not classified", it was classified into "Not classified".
4 Respiratory sensitization Classification not possible - - - - Classification is not possible since there is no data.
4 Skin sensitization Classification not possible - - - - Although it has been shown as negative in each test result of three examples employing guinea pig including the test in alignment with the OECD test guidelines in GESTIS (2003), there is one human case indicating a positive potential in the dental students exposed to the substance as an antiseptic solution (HSDB (2003), GESTIS (2003)). Therefore, it is classified into "Classification not possible."
5 Germ cell mutagenicity Not classified - - - - From the negative results in in vivo mouse micronucleus tests and rat UDS tests, and the negative results in in vitro Ames tests, chromosome aberration test and gene mutation test (GESTIS (2003), BAuA Report (2002)), it was defined as "Not classified".
6 Carcinogenicity Classification not possible - - - - Classification not possible due to lack of data
7 Reproductive toxicity Category 1B Danger H360: May damage fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
There is a description as follows in a NTP document, Review of Toxicological Literature (s-Trioxane, 1999), "By applying oral administration of 1,500, 3,870mg/kg to rats every other day, suppression of the growth of fetuses was observed and significant deformation and maternal toxicity were observed." Then, contents of the original document (Polish Journal of Occupational Medicine, 1, 51-61, 1988) were checked to find the fact that hydrocephalus (3.1%), incomplete development of skulls (16.5%) and partial deficiencies of breast bones (5.2%) had been observed in child-animals at the dose level of 770mg/kg where maternal toxicity had not been observed in the developmental toxicity study (8-20 day pregnacy) (numerical values in brackets: development rate). Therefore, it was classified in Category 1B. Incidentally, EU Annex 1 is Cat.3; R63, corresponding to GHS Category 2.
8 Specific target organ toxicity - Single exposure Category 3 (Narcotic effects) Warning H336: May cause drowsiness or dizziness (narcotic effects) P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P271: Use only outdoors or in a well-ventilated area.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P405: Store locked up.
P501: Dispose of contents/container to ...
Although it is Priority 3, it is classified into "Category 3 (Narcotic effects) since GESTIS (2003) has a description that "central nervous system disorders, such as tremulousness and relaxation, were seen in the inhalation test of the vapor (level unknown, steam saturation vapor pressure levels are 17,100 ppm) for 8 hours which employed rats, however, the subjects survived and no abnormalities were viewed by dissection seven days after." In addition, EU Annex I is Xi; R37 and is equivalent to Respiratory tract irritation.
9 Specific target organ toxicity - Repeated exposure Category 2 (respiratory system) Warning H373: May cause damage to organs through prolonged or repeated exposure (respiratory 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 Priority 3 in GESTIS (2003), there is a report of tracheal tissue damage in a 12-month inhalation study in rats at a dose equivalent to that within the range of guidance values for Category 2 (0.5 mg/L/5h/day), so it was classified as Category 2 (respiratory system).
10 Aspiration hazard Classification not possible - - - - Classification not possible due to lack of data

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) - - - - - -
11 Hazardous to the aquatic environment (Long-term) - - - - - -


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

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Model SDS by MHLW

MHLW Website (in Japanese Only)


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