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EC number: 247-722-4 | CAS number: 26471-62-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In an two generation reproductive toxicity study according OECD 416 under GLP conditions in rats, m-tolylidene diisocyanate showed no effects on animal fertility (Tyl, 1989).
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 2.18 mg/m³
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Klimisch code 1
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a two-generation reproductive toxicity study similar to OECD Guideline 416 (Tyl, 1989), m-tolylidene diisocyanate vapour was administered to male and female Sprague-Dawley weanling rats in exposure chambers at dose levels of 0, 0.02, 0.08, 0.30 ppm.
28 animals/sex/group of the first parental generation (F0) were exposed to TDI vapour at the above concentrations for 6 hours/day, 5 days/week, for a total of 10 weeks. Exposures of females continued through mating and the first 19 days of gestation and were discontinued from gestation day 20 through the fourth day postpartum. Exposures of females resumed on day 5 postpartum and continued through postnatal day 20. Exposures of F0 males were continuous from the mating period through delivery of the first F1 litters.
F1-weanlings were exposed to the same exposure concentration of TDI as their parents for 12 weeks.
Cage side observations as well as clinical observation were performed on parental animals. Furthermore the body weight was examined. Post mortem examinations included gross necropsy as well as histopathology and organ weight determination.
Postmortem examinations of the pups born alive and any pup appearing abnormal or died on the test included gross necropsy consisting of external surfaces, all orifices, cranial cavity, carcass, external and cut surfaces of the brain and spinal cord, the thoracic, abdominal, and pelvic cavities and their viscera, and cervical tissues and organs.
F0-females exhibited no differences among groups for body weight gains. In contrast, F0-males body weight gain was reduced in the first exposure week at 0.3 ppm. However, weight gain was significantly increased at the end of the study in the 0.02, 0.08, and 0.3 ppm group. Clinical signs of toxicity (nasal discharge in males and red-tinged fur in females) were observed in the high-exposure F0 group. There were no treatment-related gross lesions observed in necropsy. Histopathology revealed a significant increase in the incidence of rhinitis in the nasal turbinates of F0 animals (both sexes) exposed to 0.08 and 0.3 ppm and hyperplasia and dysplasia of the respiratory epithelium of F0 males at 0.3 ppm. The incidence of hyperplasia was also significantly increased in F0 females at 0.3 ppm. Treatment-related histopathological lesions were limited to the upper respiratory tract with tissues located deeper in the respiratory tract being less affected.
F1-pups exhibited equivalent litter sizes and body weights per litter throughout lactation. In the first 4 postnatal days, survival was increased at 0.3 ppm. There were no treatment-related gross lesions in F1 animals observed. The incidence of rhinitis was significantly increased in all dose groups (male) or in the two higher dose groups (female, respectively). Additionally, there was a significant increase in the incidence of submucosal lymphoid infiltrates in both the larynx and the trachea as well as a significant increase in the incidence of intracellular eosinophilic droplets at 0.3 ppm (male). No treatment-related effects in the trachea or larynx of F1 females were observed.
The final body weight was not reduced in both genders of F1-adult animals. Treatment-related clinical signs (perinasal encrustation and red-tinged fur) were observed in F1 females but not in F1 males at 0.08 and 0.3 ppm. Histopathology revealed lesions limited to rhinitis in F1 males at all exposure levels and in F1 females at 0.08 and 0.3 ppm.
F2 pup body weights and weight gain per litter were slightly reduced (<8 %) at 0.08 and 0.3 ppm during lactation. Only in the high dose group reduced bodyweight was persisting through day 21 (7 %).
Perinatal deaths were reduced (survival was increased) at 0.02 and 0.3 ppm. There were no treatment-related gross lesions in necropsied F2 animals.
Based on the effect of the test substance on the evaluated reproduction parameters, the NOAEC is ≥ 0.3 ppm. For body weight changes and the treatment related effects on the respiratory tract, the LOEC is 0.02 ppm.
Effects on developmental toxicity
Description of key information
In a developmental toxicity study according to OECD 414 under GLP conditions in rats (Tyl, 1988), TDI showed no embryotoxicity or teratogenicity.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 0.73 mg/m³
- Quality of whole database:
- Klimisch code 1
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a developmental inhalation toxicity study similar to OECD Guideline 414, m-tolylidene diisocyanate (TDI) was administered to 25 female Sprague-Dawley rats/dose by whole body exposure at dose levels of 0, 0.02, 0.1, and 0.5 ppm for 6 hours per day from days 6 through 15 of gestation.
Detailed clinical observations were performed and body weight was for maternal animals. Food and water consumption was measured every 3 days. A gross necropsy was performed after sacrifice on gestation day 21.Examinations of the ovary and uterine content including gravid uterine weight, number of corpora lutea, implantations, early and late resorptions were also performed. The fetal examinations included external, soft tissue, skeletal and head examinations.
No maternal mortality was observed. No significant differences in the number of pregnant/dose level, number of dams aborting, pre- and post-implantation loss, number of corpora lutea, and number of resorptions were observed. The number of total implants/litter and number of viable implants were reduced at 0.02 ppm.
Maternal weight gain was significantly depressed over the exposure period in the 0.5 ppm group. Additionally, maternal weight gain was significantly reduced early in the exposure period, gd 6 - 9, at 0.02 and 0.1 ppm. Maternal food consumption was reduced at the high dose from exposure day 9 onward. In addition, food consumption was reduced at 0.02 ppm for gd 18 - 21 due to the dam with one fully resorbed litter eating at a non-pregnant rate in this group.
The only treatment related clinical signs of toxicity were audible respiration in females at 0.5 ppm and red nasal discharge at 0.02, 0.1, and 0.5 ppm.
There were no differences in maternal gross observations at necropsy as well as no differences in gravid uterine weights, or body weight change among the groups. Hydronephrosis, a typical finding in CD- rats was observed in 2 animals at 0.1 ppm and 1 animal at 0.5 ppm.
No significant differences in litter size and weights, number of viable fetuses, or sex ratio were observed. An increased incidence of poorly ossified cervical centrum 5 at 0.5 ppm (exhibited a statistically significant increase relative to controls) indicating minimal fetotoxicity. However, this observation could be described as a common rat skeletal variation. The NOAEL for maternal and developmental toxicity is 0.1 ppm.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for reproductive or developmental toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
Additional information
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