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EC number: 221-374-3 | CAS number: 3081-01-4
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: subacute feeding study done under GLP, compared to guideline study with acceptable restrictions (e.g. no haematology, clinical biochemistry and histopathology conducted)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
- Principles of method if other than guideline:
- other: subacute feeding study
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- N-(1,4-dimethylpentyl)-N'-phenylbenzene-1,4-diamine
- EC Number:
- 221-374-3
- EC Name:
- N-(1,4-dimethylpentyl)-N'-phenylbenzene-1,4-diamine
- Cas Number:
- 3081-01-4
- Molecular formula:
- C19H26N2
- IUPAC Name:
- N1-(5-methylhexan-2-yl)-N4-phenylbenzene-1,4-diamine
- Reference substance name:
- 7PPD
- IUPAC Name:
- 7PPD
- Details on test material:
- Santoflex 14, purity: 96.2%
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: 7PPD contained in the diet
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- (ca. 0 for males and females); 5 per sex and dose group
- Dose / conc.:
- 500 ppm
- Remarks:
- (ca. 36.7 for males and 39.8 for females); 5 per sex and dose group
- Dose / conc.:
- 750 ppm
- Remarks:
- (ca. 51.8 for males and 58.2 for females); 5 per sex and dose group
- Dose / conc.:
- 1 500 ppm
- Remarks:
- (ca 101.2 for males and 134.3 for females), 5 per sex and dose group
- Dose / conc.:
- 3 000 ppm
- Remarks:
- (ca. 186.9 for males and 199.6 for females), 5 per sex and dose group
- No. of animals per sex per dose:
- 5 per sex and group
- Control animals:
- yes, plain diet
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 ppm
- Sex:
- male/female
- Basis for effect level:
- other: slight effects on body weights
- Dose descriptor:
- LOAEL
- Effect level:
- 3 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: effects on body weights and liver weights
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Analysis of Test Material and Diets
Results of analyses for test material stability conducted over a span of time approximately equal to the study length indicated the test material was stable. The homogeneity of the diet mixtures was determined to be adequate for study use. The stability of the test material/diet mixture was demonstrated for the low and high levels; stored in open containers at room temperature for 7 and 14 days. Weekly analyses of SANTOFLEX 14 antiozonant in the diet were performed on all levels for the first week of the study, and on at least one level per week thereafter.
The following table shows the overall averages (uncorrected for quality control results):
Test groups | ||||
T1 | T2 | T3 | T4 | |
Target exposure (ppm) | 500 | 750 | 1500 | 3000 |
Study mean (ppm) | 450 | 660 | 1300 | 2800 |
Standard deviation (ppm) | 20 | - | - | 71 |
Study average (% target) | 90 | 88 | 87 | 93 |
Mortality
There were no deaths during this study.
Clinical Signs
There were no adverse clinical observations seen during the study.
Body Weight
Males and females at the highest dietary level had a decrease in group mean body weight by the end of the first week of dosing. Additionally, reduced weight gains were observed in males and females at all but the lowest level for the remainder of the study. Females at the lowest dietary level were slightly (about 10 %) lighter in group mean body weight at the end of testing, while there were no significant differences in the lowest level males at any time during the study, when compared to controls. Group mean body weight data are shown in the following table:
Group | Study mean (g) | % difference from control (study mean) | % difference from control/final body weight) | Overall % gain from initial |
Males | ||||
Negative control | 335.3 | - | - | 63.6 |
T1 | 333.2 | -0.6 | -1.1 | 60.5 |
T2 | 317.0 | -5.4 | -7.8 | 48.3 |
T3 | 311.8 | -7.0 | -7.9 | 50.9 |
T4 | 289.2 | -13.7 | -15.9 | 36.7 |
Females | ||||
Negative control | 209.0 | 41.0 | ||
T1 | 195.8 | -6.3 | -9.9 | 28.7 |
T2 | 192.7 | -7.8 | -12.6 | 24.0 |
T3 | 197.6 | -5.5 | -10.2 | 27.2 |
T4 | 185.2 | -11.4 | -16.4 | 19.5 |
Food Consumption
Food consumption was reduced on a grams of food per day (GM/DAY) basis for males at all but the lowest level and females at all dietary levels, as compared to their respective controls the first week of testing and continued to be reduced for most groups during the remainder of the study. T. Overall group mean food consumption data are summarized in the following table:
Food consumption
g/day | g/kg/day | |||
Group | Study Mean | % Difference from control (study mean) | Study mean | % Difference from control(study mean) |
Males | ||||
Negative control | 76.3 | - | 27.0 | - |
T1 | 73.3 | -3.9 | 25.8 | -4.4 |
T2 | 69.0 | -9.6 | 22.9 | -15.2 |
T3 | 67.5 | -11.5 | 22.1 | -18.1 |
T4 | 62.3 | -18.3 | 18.9 | -30.0 |
Females | ||||
Negative control | 86.8 | - | 18.9 | - |
T1 | 79.5 | -8.4 | 16.0 | -15.3 |
T2 | 77.6 | -10.6 | 15.3 | -19.0 |
T3 | 87.3 | 0.6 | 17.8 | -5.8 |
T4 | 66.5 | -23.4 | 12.7 | -32.8 |
Overall study averages for consumption of test material (mg SANTOFLEX 14/kg body weight/day) were approximately 36.7, 51.8, 101.2 and 186.9 in males and 39.8, 58.2, 134.3 and 199.6 in females, respectively.
Gross Pathology
There were no gross lesions that were attributed to treatment
Slightly increased (not statistically significant) absolute liver weights occurred in the high level males (+6 %) and females (+10 %). Increased relative liver weights were seen at the same dietary level and also in the next two lower level male and female groups, but were attributed to decreases in body weights at those levels.
Liver weights absolute (after scheduled sacrifices)
Group | Liver weight (g) (mean ± S.E.) | % from control |
Males | ||
Negative control | 12.301 ± 0.528 | 100 % |
T1 | 12.545 ± 0.937 | 102 % |
T2 | 12.165 ± 0.574 | 99 % |
T3 | 11.756 ± 0.343 | 96 % |
T4 | 13.044 ± 0.665 | 106% |
Females | ||
Negative control | 7.405 ± 0.387 | 100 % |
T1 | 7.376 ± 0.395 | 99.7 % |
T2 | 7.473 ± 0.517 | 100.1% |
T3 | 7.593 ± 0.110 | 103 % |
T4 | 8.136 ± 0.170 | 110 % |
Liver weights relative to terminal body weight
Group | rel liver weight (%) (mean ± S.E.) |
Males | |
Negative control | 3.401 ± 0.132 |
T1 | 3.494 ± 0.126 |
T2 | 3.678 ± 0.115 |
T3 | 3.670 ± 0.109 |
T4 | 4.273 ± 0.106* |
Females | |
Negative control | 3.412 ± 0.119 |
T1 | 3.766 ± 0.150 |
T2 | 3.899 ± 0.178 |
T3 | 3.924 ± 0.060* |
T4 | 4.512 ± 0.089* |
*significant different from control (p<0.05)
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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