Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 229-175-3 | CAS number: 6422-83-9
- 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
- Reproduction / developmental toxicity screening test, oral (gavage), rat (Crl:WI(Han)) m/f (OECD TG 421; GLP), dose levels: 0, 10, 30, 60 mg/kg bw/d: parental NOAEL: 60 mg/kg; fertility NOAEL, females: 60 mg/kg; developmental NOAEL: 60 mg/kg bw
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 60 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The available study was conducted according to guideline and is of high quality.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a Reproduction/Developmental Toxicity Screening Test according to OECD guideline 421 (adopted July 2015) 2,4-Bismaleimidotoluene (100% a.i.) was administered to groups of 10 Wistar rats/sex/dose by gavage at dose levels of 0, 30 and 60 mg/kg bw/d.
The mean number of corpora lutea was not significantly different from that in the dose groups compared with the control animals. However, a slightly reduced fertility index (number of females pregnant / number of females copulated X 100) of 80 % in the MD group compared to 90 % in all other groups. In the absence of dose response dependency, the finding was not considered to be of toxicological relevance.
During the treatment period of this study, few mortalities/moribund sacrifice were observed. Histopathologically, the cause of death/morbidity in two animals was considered to be due to gavaging error (tracheal inflammation, thymic inflammation with plant particles). The cause of death/morbidity could not be established for the other animals. The deaths were considered not treatment related.
Diarrhoea and moving the bedding as predominant clinical signs were observed in males and females. Other observed clinical signs were also present in the control group and, thus, considered incidental. Moving the bedding was observed transiently after dosing in the MD and HD and therefore considered to be a sign of discomfort due to local reaction to the test item rather than a systemic adverse effect.
No test item related or statistically significant effect on food consumption was observed in males and females during the whole study period, except for a statistically significant increase in group mean food consumption in female MD group observed during premating day 7-14 when compared with the controls. Due to lack of dose dependency and consistency, this statistically significant effect on female food consumption was considered to be incidental and not related to the treatment with test item.
There were no effects on the survival of the pups from PND 1 through PND 13 in the dose groups when compared to the control group. A marginally higher mean mortality of pups between PND 4 and PND 13 was observed in the HD group (1.01%) compared to the control group (0.00%).However, this effect did not achieve statistical significance. There were also few mortalities/missing pups observed from LD and MD group, and as a result a higher mean mortality of pups between PND 0 and PND 4 was observed in the LD and MD groups (2.81 and 0.89 %, respectively) compared to the control group (0.00%). Due to lack of dose dependency and consistency, this effect in LD and MD group was not considered to be treatment related.
No treatment-related changes were noted in any of the remaining parameters investigated in this study (i.e. body weight development, estrous cycle, litter data [ total number of pups born, number of male pups, number of female pups, sex ratio, number of live pups, still births and runts on PND 0 as well as number of male pups, number of female pups, number of live pups and sex ratio on PND 4 and PND 13], litter weight, precoital interval and duration of gestation, pre- and post-natal data [ number of corpora lutea, number of implantation sites, number of live pups (PND 0, PND 4 and PND 13) and percentage of pre- and post-implantation loss], thyroid hormone analysis, macroscopic changes, organ weights, gross lesions).
Based on these results, the following NOAELs were derived:
parental NOAEL: 60 mg/kg
fertility NOAEL, females: 60 mg/kg
developmental NOAEL: 60 mg/kg
Effects on developmental toxicity
Description of key information
- Reproduction / developmental toxicity screening test, oral (gavage), rat (Crl:WI(Han)) m/f (OECD TG 421; GLP), dose levels: 0, 10, 30, 60 mg/kg bw/d: parental NOAEL: 60 mg/kg; fertility NOAEL, females: 60 mg/kg; developmental NOAEL: 60 mg/kg bw
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 60 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The study was conducted according to guideline and is of high quality.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the existing relevant study with 2,4 -Bismaleimidotoluene does not need to be classified for toxicity to reproduction, developmental toxicity and teratogenicity according to the criteria given in regulation (EC) 1272/2008. Therefore labelling is not necessary.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.