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EC number: 203-265-2 | CAS number: 105-05-5
- 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
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Results of an study conducted in accordance with generally accepted scientific principles. Possible deficiencies in the reporting of the endopoint do not affect the quality of relevant results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- other: slc:SD
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration of treatment / exposure:
- Male: 44 days including 14 days before mating.
Female: from 14 days before mating to day 3 of lactation.
Premating exposure period: male, 14 days; female, 14 days - Frequency of treatment:
- 7 days/week
- Remarks:
- Doses / Concentrations:
0 mg/kg
Basis:
no data - Remarks:
- Doses / Concentrations:
30 mg/kg
Basis:
no data - Remarks:
- Doses / Concentrations:
150 mg/kg
Basis:
no data - Remarks:
- Doses / Concentrations:
750 mg/kg
Basis:
no data - No. of animals per sex per dose:
- 12 animals/sex/group
- Control animals:
- yes, concurrent vehicle
- Reproductive function: oestrous cycle:
- no effects observed
- Dose descriptor:
- NOEL
- Effect level:
- 750 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- The external examination of pups revealed no effects attributable to the administration of test substance.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The body weights of fetuses showed the favorably growths until Day 4 of lactation.
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 750 mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
- Reproductive effects observed:
- not specified
- Conclusions:
- The influences of test substance on reproductive and developmental toxicity were not observed in both male and female rats receiving 750 mg/kg/day, therefore maximum NOELs were considered to be 750 mg/kg/day in both sexes.
Reference
Observation of delivery, all gestation animals delivered of pups normally, and there were not a treatment-related effect throughout the lactation period.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 750 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
A reproductive/developmental screening study was conducted in rats at 0, 30, 150 and 750 mg/kg bw/day (by gavage) to investigate potential adverse effect of 1,4-diethylbenzene on reproductive performance, including mating, fertility and oestrus cycle and also for dams during the pregnancy and lactation period, according to OECD Guideline 422. Under the conditions of this study, no test substance-related effects were observed on reproductive performance at any dosage level. Based on these results, 750 mg/kg bw/day was considered to be the NOAEL for reproductive toxicity.
Justification for selection of Effect on fertility via oral route:
Only one study available. The study is a combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test.
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Results of an study conducted in accordance with generally accepted scientific principles. Possible deficiencies in the reporting of the endopoint do not affect the quality of relevant results.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 422
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration of treatment / exposure:
- Male: 44 days including 14 days before mating.
Female: from 14 days before mating to day 3 of lactation.
Premating exposure period: male, 14 days; female, 14 days - Remarks:
- Doses / Concentrations:
0
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
30
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
150
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
750
Basis:
nominal in diet - Maternal examinations:
- All gestation animals delivered pups normally.
- Fetal examinations:
- The body weight of fetuses showed the favorably growths until day 4 of lactation.
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
The results observed in mating, fertility and estrous cycle did not reveal any effects attributable to the administration of test substance.
Observation of delivery, all gestation animals delivered of pups normally, and there were not a treatment-related effect throughout the lactation period. - Dose descriptor:
- NOAEL
- Effect level:
- 750 mg/kg bw/day
- Based on:
- no data
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The necropsy of stillborn, dead pups until day 4 of lactation and newborns at day 4 of lactation did not reveal any effects attributable to the administration of the test substance. - Dose descriptor:
- NOAEL
- Effect level:
- 750 mg/kg bw/day
- Based on:
- no data
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Under the conditions of this screening study, no test substance-related effects were observed on the general physical condition of F1 pups at any dosage level. As such, a dosage level of 750 mg/kg bw/day was considered to be the no-observed-adverse-effect level (NOAEL) for maternal and teratogenic toxicity.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 750 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
A reproductive/developmental screening study was conducted in rats at 0, 30, 150 and 750 mg/kg bw/day (by gavage) to investigate potential adverse effect of 1,4-diethylbenzene on reproductive performance, including mating, fertility and oestrus cycle and also for dams during the pregnancy and lactation period, according to OECD Guideline 422. Under the conditions of this study, no test substance-related effects were observed on reproductive performance at any dosage level. In the absence of any effects on the general physical condition of the F1 pups, the NOAEL for neonatal toxicity (F1 offspring) was set to 750 mg/kg bw/day.
The (Q)SAR prediction as "non-toxic" is considered valid and supports the results observed in the test according to OECD 422.
The prediction determines the presence or absence of toxicity (indicated as Tox Index +1 and -1) based on modelling compared with a training set. 1,4 -diethylbenzene falls into the applicability domain of the model. The predicted value is "non-toxic".Due to the specific nature of the dataset, it being comprised of experimental data for different species, including human data, the dose limits for each particular species cannot be directly extracted from the prediction. However, most commonly available comparison would be data for rats, where the corresponding NOAEL limits can be estimated to be in the range of 500 – 750 mg/kg/day as reported in this Chemical Safety Report.
Justification for selection of Effect on developmental toxicity: via oral route:
Only one study available. The study is a combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test.
Justification for classification or non-classification
The reproductive/developmental screening study was conducted in rats to investigate the potential adverse effect of 1,4-diethylbenzene on reproduction, including embryo/foetal development. No adverse effects on reproductive/developmental parameters were noted at doses up to 750 mg/kg bw/day. Also, there were no effects on the general physical condition of the F1 pups at any dose. As a conclusion 1,4 -diethylbenzene is not classified as hazardous for these endpoints.
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.
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