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EC number: 212-344-0 | CAS number: 793-24-8
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- limited documented study report (e.g. no individual data availabe for organ weights), with methodological deficiencies (e.g. particle size distribution: only <2% of particle-size range within the recommended range of 1.5 to 3.0 µg and whole body exposure); thus the exposure of all relevant regions of the respiratory tract is questionable.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Reference Type:
- publication
- Title:
- Monsanto Chemical Co. (1976) unpublished study Project No. BT-76-142. Cited from BUA Report 208, 1996
- Author:
- BUA Report
- Year:
- 1 996
Materials and methods
- Principles of method if other than guideline:
- Method: other subacute dust inhalation toxicity study
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
- EC Number:
- 212-344-0
- EC Name:
- N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
- Cas Number:
- 793-24-8
- Molecular formula:
- C18H24N2
- IUPAC Name:
- N1-(4-methylpentan-2-yl)-N4-phenylbenzene-1,4-diamine
- Details on test material:
- Santoflex 13, Lot no. KD03-017
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- other: unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- 6 h/d and 5d/w
Doses / concentrations
- Remarks:
- Doses / Concentrations:
51, 247, 498 mg/m3
Basis:
- No. of animals per sex per dose:
- 5 per dose and sex
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Post-exposure period: no data
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 51 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: hypoactivity of treated animals at exposure day 8, decrease in hemoglobin value (13%) and hematocrit value (9 %) in females
- Dose descriptor:
- LOAEL
- Effect level:
- 247 mg/m³ air
- Sex:
- male/female
- Basis for effect level:
- other: hypoactivity, swollen snout, scratching, changes in hematology parameters, increased liver weights males
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Particle size distribution:
Sample of airborn dust was collected weekly from the test atmosphere for conducting microscopic determination of particle size distribution. Particles were counted with respect to four size ranges: 5 microns or smaller, 6 to 10 microns, 11 to 25 microns and larger than 25 microns.
Particle size distribution:
Particle size range µm | Percent of total counted week |
|||
low dose | 1 | 2 | 3 | 4 |
1 to 5 | 1.9 | 0.9 | 2.3 | 0.9 |
6 to 10 | 12.1 | 9.5 | 10.9 | 4.3 |
11 to 25 | 31.5 | 28.5 | 29.8 | 20.4 |
> 25 | 54.5 | 61.1 | 57.0 | 74.3 |
mid dose | ||||
1 to 5 | 1.8 | 1.1 | 1.0 | 1.3 |
6 to 10 | 12.3 | 10.0 | 7.5 | 8.9 |
11 to 25 | 36.2 | 25.0 | 20.0 | 37.8 |
high dose | 1.9 | 1.3 | 0.9 | 0.8 |
1 to 5 | 7.7 | 12.6 | 11.4 | 11.4 |
6 to 10 | 17.3 | 31.2 | 36.8 | 37.6 |
11 to 25 | 73.1 | 55.0 | 50.9 | 50.2 |
total number of particle count for week 1 through 4 were (low dose): 257, 221, 265 and 230, respectively.
Mortality: one male from the mid dose died during the investigation period
Clinical signs: hypoactivity was noted in all test groups. Animals from the mid and high dose groups exhibited swollen snouts and scratching. One male of the mid dose showed a cylindrical fleshy structure (approx. 1 mm in diameter and 3 mm in lengh) on the middorsal region.
Mean body weight gains: treated animals were comparable to control
Organ weights (no individual data available, no statistical summary tables were availabe for this data,data for organ weight ratios calculation are incomplete):
Kidney(no single organ weights availabe): low dose females exhibited significant (P<0.05) higher organ to brain weight ratio than control; mid dose females exhibited significantly (P<0.05) higher organ weights and organ to body weight ratios than control females
Liver (no single organ weights available): low and mid dose males exhibited significantly (P<0.01) higher organ weights than control males; high dose males exhibited significantly (P<0.05) higher organ weights than control males; mid dose males exhibited significantly (P<0.05) higher organ to body weight ratios than control males
Low dose females exhibited signifcantly (P<0.05) higher organ weights than controls; mid and high dose females exhibited significantly higher organ weights (P<0.01) as well as higher organ body and organ to brain ratios than control females.
Lung( no single organ weights availbale): High dose males exhibited signifcantly lower organ weights (P<0.01) as well as lower organ to body and organ to brain weight ratios (P<0.05)than control males; mid dose females exhibited significantly (p<0.05) lower organ weights and organ to brain weight ratios than control females.
Spleen(no single organ weights availabe): mid dose males exhibited significantly (P<0.05) higher organ weights
and organ to body weight ratios than control males
There were no signifcant differences between test and control animals with respect to brain, gonads and heart weight data.
Gross or histopathologic alterations:
No gross or histopathologic alterations attrinutable to the effects of the test material were observed in any of the treated rats examined. Cornealopacities were observed in one female rat in each of the mid and high dose treatment groups. histopathologic evaluation of the affected eye from the rat in the high dose group revealed it to be histologically normal.
Haematology:
Changes in haematology was noted in treated animals.
A dose-dependent decrease in hemoglobin and dose-dependent increase in leukocytes were noted in treated females. A decrease in the erythrocyte count and hematocrite value were noted in treated males and females (not dose dependent). A dose dependent decrease in MCV(Mean corpuscular volume)and MCH
(Mean corpuscular hemoglobin)was noted in treated males.
Clinical Chemistry:
BUN (Blood urea nitrogen):
Values for the mid dose males were significantly higher (P<0.05%) than control.
SGPT (Serum Glutamic pyruvic transaminase):
the values for the mid and high dose males were signifcantly lower (P<0.05) than control; in the absence of histopathologic alterations attributable to the test material the meaning of these changes are unclear.
Urinalysis:
Mean values for content of blood, ketones, glucose and protein of urine, for pH and for microscopic constituents of urinary sediments determined in samples obtained from treated rats were normal when compared to the values for control rats.
Applicant's summary and conclusion
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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