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EC number: 411-280-2 | CAS number: 74091-64-8 MR-8A; MR-N2; NBDI
- 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
Description of key information
Acute oral toxicity study in rats: LD50 oral: 1842 mg/kg for male rats and 1201 mg/kg for female rats. Acute inhalation toxicity study in rats: 4h-LC50: 0.054 mg/L.
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:
- July 9, 1990 - August 12, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted equivalent to OECD 401 and GLP principles.
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guideline for Toxicity Study of Drugs (1989)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan
- Age at study initiation: 5 weeks
- Weight at study initiation: 120-130 g for males and 95-110 g for females
- Housing: polycarbonate cage with hard wood chip bedding
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 25 C
- Humidity (%): 40 to 70%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE: Olive oil
MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g bw - Doses:
- 700 mg/kg
1000 mg/kg
1400 mg/kg
2000 mg/kg
(both sexes) - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs of all rats were inspected and recorded 0.5, 1, 3 and 6 hours after administration and at least once a day thereafter for 14 days.
The bodyweight of all rats was measured shortly before administration and on the 3rd, 7th and 14th day after administration (defining the day of administration as the 0th day)
- Necropsy of survivors performed: yes (and the dead animals were autopsied at discovery)
- Other examinations performed: no - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 201 mg/kg bw
- 95% CL:
- 826 - 1 744
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 842 mg/kg bw
- 95% CL:
- 1 387 - 2 446
- Mortality:
- Male: 700 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 1400 mg/kg bw; Number of animals: 5; Number of deaths: 1
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 3
Female: 700 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 1000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 1400 mg/kg bw; Number of animals: 5; Number of deaths: 3
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 4 - Clinical signs:
- other: Rats of both sexes at all dose levels had soiled hair around the anus, soft feces and diarrhea between 30 minutes and the second day after administration. One male rat of the 1400 mg/kg dose group had reduced spontaneous movement on the next day after adm
- Gross pathology:
- -Autopsy at the end of the observation period revealed thickening of the stomach internal wall in all rats
-Greyish changes at the stomach wall and yellow contents in the small intestines (females: 1400 and 2000 mg/kg; males: 2000 mg/kg bw only)
-Testes atrophy at the highest dose in males - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 oral was 1842 mg/kg for male rats (95% confidence limits: 1387 to 2446 mg/kg) and 1201 mg/kg for female rats (95% confidence limits: 826 to 1744 mg/kg).
- Executive summary:
The substance was administered orally to SD strain rats (SPF) of both sexes and its acute toxicity was determined. The dosage levels were 700, 1000, 1400 and 2000 mg/kg for rats of both sexes. Each dose group consisted of 5 rats.
The LD50 oral was 1842 mg/kg for male rats (95% confidence limits: 1387 to 2446 mg/kg) and 1201 mg/kg for female rats (95% confidence limits: 826 to 1744 mg/kg).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 201 mg/kg bw
- Quality of whole database:
- A reliable study is used.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 8, 1992 - Novemver 16, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted equivalent to OECD 403 and GLP principles.
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA Guideline for Toxicity of Chemicals (1989)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River's Laboratory
- Age at study initiation: 6 to 8 weeks
- Housing: individually in stainless steel, wire bottom cages
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 degrees Celsius
- Humidity (%): 55 +/- 15%
- Air changes (per hr):10 changes/hour
- Photoperiod (hrs dark / hrs light): 12/12 hrs
IN-LIFE DATES: From: November 2, 1992 To: November 16, 1992 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- Similar to the design described by Cannon et al, 1983
(W.C. Cannon et al, The flow-past chamber: an improved nose-only exposure system for rodents, Amer. Ind. Hyg. Assoc., 44(12), p. 923-928, 1983) - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Nominal concentrations:
0.015 mg/L (measured: 0.016 mg/L)
0.05 mg/L (measured: 0.053 mg/L)
0.1 mg/L (measured: 0.12 mg/L)
0.25 mg/L (measured: 0.24 mg/L)
0.5 mg/L (measured: 0.65 mg/L)
5 mg/L (measured: 4.65 mg/L) - No. of animals per sex per dose:
- 5 male and 5 female rats per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations: twice daily
Body weights: day 1, 8 and at necropsy
- Necropsy of survivors performed: yes;
Each necropsy included examination of the external surface of the body; all body orifices; the cranial, thoracic, abdominal and pelvic cavities and their contents; special attention was given to the lungs and upper respiratory tract.
- Other examinations performed: no - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 54 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- other: NOAEC (local effects)
- Effect level:
- 16 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- other: LOAEC (local effects)
- Effect level:
- 53 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: Based on labored respiration, rales and nasal discharge
- Sex:
- male/female
- Dose descriptor:
- other: NOAEC (systemic effects)
- Effect level:
- 16 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: Based on mortality at next dose level
- Mortality:
- Male: 0.50 mg/L; Number of animals: 5; Number of deaths: 5 Male: 0.25 mg/L; Number of animals: 5; Number of deaths: 5 Male: 0.10 mg/L; Number of animals: 5; Number of deaths: 5 Male: 0.05 mg/L; Number of animals: 5; Number of deaths: 2 Male: 0.015 mg/L; Number of animals: 5; Number of deaths: 0 Female: 0.50 mg/L; Number of animals: 5; Number of deaths: 5 Female: 0.25 mg/L; Number of animals: 5; Number of deaths: 5 Female: 0.10 mg/L; Number of animals: 5; Number of deaths: 5 Female: 0.05 mg/L; Number of animals: 5; Number of deaths: 1 Female: 0.015 mg/L; Number of animals: 5; Number of deaths: 0
- Clinical signs:
- other: Signs of toxicity related to dose levels: - The surviving animals in the 0.05 mg/l dose group were thin in appearance and had a rough coat. - In the higher dose groups all animals had a laboured respiration and red nasal discharge - The animals in the l
- Body weight:
- The body weights of rats exposed to the lowest dose increased throughout the entire study. Effects on the body weight gain were observed at the next dose: body weights were decreased by 8% on day 8 compared to day 1 in male and female rats.
- Gross pathology:
- Effects on organs: The animals in the dose groups with 0.5 and 0.25 mg/l had a
pale discoloration of the lungs.
One animal of the highest dose group had white contents in the left lung. - Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- The 4h-LC50: 0.054 mg/L
NOAEC (local effects): 16 mg/m3
LOAEC (local effects): 53 mg/m3 based on labored respiration, rales and nasal discharge
NOAEC (systemic effects): 16 mg/m3
LOAEC (systemic effects): 53 mg/m3 based on a 8% bodyweight reduction between day 1 and day 8 of exposure in the group of males as well as in the group of females (based on the means)
Reference
Treatment-related abnormal clinical signs were observed in all exposure groups, except the lowest dose group. All animals exposed to the lowest dose were clinically normal throughout the entire study period. These signs were thin appearance, rough coat, labored respiration, rales and red nasal discharge.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 54 mg/m³ air
- Quality of whole database:
- A reliable study is used.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the acute oral toxicity study in rats the substance is classified for Acute Toxicity in Category 4, harmful if swallowed (LD50 oral: 1201 mg/kg for female rats). Based on the acute inhalation toxicity study in rats the substance is classified for Acute Toxicity in Category 2, fatal if inhaled (4h-LC50: 0.054 mg/L, mist).
Note: harmonized classification and labelling (see Annex VI Table 3.1 of EC Regulation No 1272/2008). Catalogus number: 615-029-00-X.
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