GHS Classification Result

Chemical Name:Diisodecyl phthalate
CAS:26761-40-0

Result:
ID: 22A4029
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2010
Reference Manual: GHS Classification Guidance by the Japanese Government (July, 2010)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement 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 - - - - Liquid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Liquid (GHS definition)
5 Gases under pressure Not applicable - - - - Liquid (GHS definition)
6 Flammable liquids Not classified - - - - Its flash point reported 217 degC (closed-cup) (IUCLID (2000)) is >= 93 degC.
7 Flammable solids Not applicable - - - - Liquid (GHS definition)
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 classified - - - - Since its auto ignition point is 402 degC (ICSC (1998)), it is considered that the substance does not ignite at room temperature.
10 Pyrophoric solids Not applicable - - - - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to liquid substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - - The substance is an organic compound containing oxygen which is chemically bonded only to carbon.
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule.
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - Based on the rat LD50 values of > 15000 mg/kg, > 29100 mg/kg and > 62080 mg/kg (EU-RAR 36 (2003)), the substance was classified as "Not classified".
1 Acute toxicity (Dermal) Not classified - - - - Based on the rabbit LD50 values of 3160 mg/kg and > 9700 mg/kg, and the rat LD50 value of > 2910 mg/kg (EU-RAR 36 (2003)), the substance was classified as "Not classified". For further information, the applications of 3160 mg/kg for rabbits and 2910 mg/kg for rats, each caused no mortality (EU-RAR 36 (2003)).
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Not classified - - - - Based on the rat LC50 value of > 12.54 mg/L/4hrs (EU-RAR 36 (2003)), the substance was classified as "Not classified". Since its test concentration (12.54 mg/L) is higher than the saturated vapor pressure concentration (1.27E-05 mg/L), it was judged the test to be carried with the mist.
2 Skin corrosion/irritation Not classified - - - - Six rabbits were exposed 0.5 ml of the test substance for 4 hours with semi-occlusive condition, and only very slight erythema in one animal was noted at 24 hours after removal of the patch, no other irritating signs were observed (EU-RAR 36 (2003)). Also, in another test in which 3 rabbits were exposed to the substance with the same condition, only slight erythema in one animal was noted at 24 and 48 hours (EU-RAR 36 (2003)). In the 24-hour patch test in human, occlusive application of 0.2 ml of undiluted test substance to 15 subjects caused no signs of irritation after 30 minutes and 24 hours of patch removal. Based on the information, the substance was classified as "Not classified".
3 Serious eye damage/eye irritation Not classified - - - - In the rabbit test (OECD TG 405) treated with 0.1 ml of undiluted test substance to 3 animals, redness of the conjunctiva in all animals was observed at 1 hour after treatment, no reactions were noted at 24, 48 and 72 hours (EU-RAR 36 (2003)). Also, in other rabbit test by instillation of 0.1 ml of undiluted test substance to 6 animals, all treated eyes showed a mild to moderate conjunctival redness (mean score 1) and mild chemosis was noted in 2/6 treated eyes at 1 hour after treatment, and 4/6 eyes showed mild redness at 24 hours after treatment (mean score 0.5). All the eyes were normal at 48, 72 hours and on day 7 after treatment (EU-RAR 36 (2003)). Based on the information, the substance was classified as "Not classified".
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - In the modified Buehler test using guinea pigs, clear positive reaction (positive ratio 15/20 (75%)) was reported (EU-RAR 36 (2003)). But in the other two tests (Buehler tests and maximization tests), there was no positive reaction, and negative results were reported (EU-RAR 36 (2003)). In humans, only one case of allergic contact dermatitis was reported (EU-RAR 36 (2003)). On the other hand, in repeated patch tests (modified Draize procedure) for 104 volunteers, negative result was shown because of no evidence of sensitization (EU-RAR 36 (2003)). In the irritant and allergic patch test conducted by the Finnish Institute of Occupational Health on 144 patients, no allergic reactions were reported (EU-RAR 36 (2003)). Incompatible results are led from the data mentioned above, and it can be judged that the information are insufficient for classification. Thus, the substance was classified as "Classification not possible".
5 Germ cell mutagenicity Not classified - - - - The substance was classified as "Not classified" based on the negative results in the micronucleus test using bone marrow of mice by oral administration (in vivo mutagenicity test in somatic cells) (EU-RAR 36 (2003)). As relevant information, as for in vitro studies, negative results in the Ames test and the gene mutation test using mouse lymphoma L5178Y cells (EU-RAR 36 (2003)) were reported.
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging 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 ...
In the two-generation reproduction study by dietary administration in rats, there were no adverse effects in reproductive index such as copulation index, fertility index at the doses that cause general toxicity such as significant increase in liver and kidney weights in parental animals, however, decrease in viability indices (on day 1 and day 4) in F2 generation was observed (EU-RAR 36 (2003)). Therefore, the substance was classified as Category 2. As relevant information, in the oral administration study using pregnant rats during the organogenetic period, increase in skeletal variations (extra cervical ribs and rudimentary lumbar ribs) were observed. However, significant increase in external, visceral and skeletal malformation incidence were not seen (EU-RAR 36 (2003)).
8 Specific target organ toxicity - Single exposure Not classified - - - - No deaths and no clinical signs occurred in rats administered orally at 15000 mg/kg, far beyond the range of the guidance values, and also, no macroscopic changes were observed (EU-RAR 36 (2003)). Additionally, in rabbits applied dermally at 3130 mg/kg, a dose over a range of the guidance values, clinical signs containing anorexia and dark red lungs at autopsy were observed when applied on abraded skins, while no systemic effects other than erythema as a local effect were found when applied on normal skins (EU-RAR 36 (2003)). In rats treated dermally with 2910 mg/kg, no clinical signs and no gross pathological abnormalities at necropsy were also detected (EU-RAR 36 (2003)). Furthermore, in an acute inhalation study in rats exposed by mist (at the test concentrations of 5.6, 9.72 and 12.54 mg/L, all of them were over the range of the guidance values), agitation and unkempt appearance were observed as clinical signs of post-exposure, and the only gross pathological findings observed at necropsy were the presence of numerous dark red foci in the lungs, observed frequently higher in the treated groups (EU-RAR 36 (2003)). Based on the results of the animal studies as described above, it was considered that the classification corresponded to "Not classified" in any routes of oral, dermal and inhalation.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - It was reported that no obvious toxic signs were observed and the animals were tolerable in repeated oral dose studies using rats, NOAEL in the 28-day feeding study was 5000 ppm (600 mg/kg/day) (converted dose level as that of 90-day study: 187 mg/kg/day), and NOAELs of males and females in the 90-day feeding study were 3200 ppm (200 mg/kg/day) and 800 ppm (60 mg/kg/day), respectively (EU-RAR 36 (2003)). In another 3-month feeding study with rats, although suppression of body weight gain and increased weights in liver and kidney were seen, no treatment-related histopathological change was detected (EU-RAR 36 (2003)) and any significant toxicological findings were not reported. In the 13-week feeding study with dogs that was considered more relevant in evaluation of the substance, hypertrophy and vacuolation of hepatocytes were found at the dose levels equivalent to ca. 15 - 300 mg/kg/day, which were minimal and had no dose-dependency with no alterations in liver enzymes such as ALT and AST, thereby the findings were not considered as toxicologically significant (EU-RAR 36 (2003)). Based on the results mentioned above, the classification was relevant to "Not classified" in oral route. While, in inhalation route, rats exposed to mist at 0.5 mg/L for 2 weeks showed slight changes in the lungs and liver, but the data was not enough to classify (EU-RAR 36 (2003)). Furthermore, no data were available for dermal exposure. Therefore, the substance was classified as "Classification not possible" for specific target organ toxicity (repeated exposure) .
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Not classified - - - - Classified as "Not classified" since any toxic effects were not reported for algae, crustacea or fish at concentrations up to the water solubility (0.18 mg/L) (EU-RAR, 2003).
11 Hazardous to the aquatic environment (Long-term) Category 4 - - H413: May cause long lasting harmful effects to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Classified into Category 4 since it is poorly soluble substance (water solubility: 0.28 mg/L (PHYSPROP Database, 2011)) for which no acute toxicity is reported at levels up to the water solubility, that leads the conclusion of "Not classified" for its acute toxicity, and it is not rapidly degradable (OECD 301C: BOD 54% (EU-RAR, 2003)) and its Log Kow = 10.36 ( > 4) (10.36 (PHYSPROP Database, 2011)).
12 Hazardous to the ozone layer Classification not possible - - - - This substance is not listed in Annexes to the Montreal Protocol.


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

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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