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Diss Factsheets
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EC number: 695-930-2 | CAS number: 13676-53-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
LD50 (experimental) >2000 mg/kg bw (LD50 cut-off = 5000 mg/kg bw), study conducted according to OECD 423, GLP
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-04-03 to 2017-07-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 December, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-10 weeks
- Weight at study initiation: step 1, animals no. 1 – 3: 152 - 169 g; step 2, animals no. 4 – 6: 165 - 174 g; step 3, animals no. 7 – 9: 173 - 186 g
- Fasting period before study: food was withheld from the test animals for 16 to 19 h prior to test start
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): ad libitum; Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): ad libitum; tap water, sulphur acidified to a pH value of approximately 2.8
- Acclimation period: at least five days under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.3 g and 2.0 g
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: vehicle was chosen due to its non-toxic characteristics
- Lot/batch no. (if required): MKBZ9899V
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- 300 mg/kg bw in the first step and 2000 mg/kg bw in the second and third step
- No. of animals per sex per dose:
- 3 per step
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing on day 1 (prior to start), 8 and 15, clinical examination was performed after dosing with special attention during the first 4 h post-dose period and once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy incl. macroscopic findings - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks:
- experimental
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- During step 1 (dose: 300 mg/kg bw) of the test no mortality was observed, during step 2 (dose 2000 mg/kg bw) one animal died spontaneously. During step 3 no compound-related mortality was reported.
- Clinical signs:
- other: The animals in step 1 (dose 300 mg/kg bw) exhibited the following clinical signs either until day 2 post exposure (animal 1 & 2) or 240 min post exposure (animal 3): Slightly reduced spontaneous activity, sunken flunks, slight piloerection, hunched postur
- Gross pathology:
- The necropsy of the spontaneously died animal revealed a dark discoloured duodenum, jejunum and ileum with Peyer’s patches. No specific pathological changes were recorded for surviving animals.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- In the present study conducted according to OECD guideline 423 (adopted 17 December 2001), m-Xylylenebismaleimide was tested in three steps and two doses for acute oral toxicity. In step 1 300 mg/kg bw were adminstered and in steps 2 and 3 2000mg/kg bw were administered to three female rats each group and the animals were observed for 14 days. There were no premature deaths in step 1, thus step 2 was performed, one animal died in step 2 and all animals showed clinical signs during the first 5 to 7 days which were reversible. Body weight loss occurred in step 2 and 3 but all animals gained weight in a normal range at the end of the study.
Thus, according to Regulation (EC) No 1272/2008 (CLP) m-Xylylenebismaleimide is not classified with regard to acute oral toxicity; according to GHS (Globally Harmonized Classification System) m-Xylylenebismaleimide is classified into Category 5 and has obligatory labelling requirements for toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The value was determined in a study conducted according to OECD guideline 423 and was GLP-compliant. Therefore, the results are of high quality.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the present study conducted according to OECD guideline 423 (adopted 17 December 2001), m-Xylylenebismaleimide was tested in three steps and two doses for acute oral toxicity. In step 1, 300 mg/kg bw were adminstered and in steps 2 and 3, 2000mg/kg bw were administered to three female rats each group and the animals were observed for 14 days. There were no premature deaths in step 1, thus step 2 was performed, one animal died in step 2 and all animals showed clinical signs during the first 5 to 7 days which were reversible. Most prominent clinical signs were reduced spontaneous activity, sunken flunks, piloerection , half eyelid closure, prone position and between observation day 3 and 4 diarrhoea and weight loss. Body weight loss occurred in step 2 and 3 but all animals gained weight in a normal range at the end of the study. between observation day 7 and 15 there were no specific findings in step 2 and 3. The animal that died showed discoloured, dark duiodenum, jejunum, ileum - with Peyer´s patches- during necropsy. Necropsy was also performed with the remaining animals at day 15 but showed no specific findings.
Oral LD50 (rat, females) >2000 mg/kg bw (LD50 cut-off = 5000 mg/kg bw)
Justification for classification or non-classification
Based on the available, reliable and relevant data m-Xylylenebismaleimide is not classified with regard to acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP); according to GHS (Globally Harmonized Classification System) m-Xylylenebismaleimide is classified into Category 5 and has obliatory labelling requirements for toxicity.
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