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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- 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, purity: 100%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- positve mating was confirmed by the presence of a copulatory plug
- Duration of treatment / exposure:
- GD 6 - 15
- Frequency of treatment:
- once daily
- Duration of test:
- study termination on gestation day 20
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sex: female
Duration of test: sacrifice on GD 20
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Mortality:
Survival was 100% in all study groups.
No abortions or premature deliveries occurred during the study period. The pregnancy rate was 80% in the control group and 92% in the other study groups.
Clinical signs:
Clinical signs which could be related to test article administration occurred during the treatment period in the mid and high dose groups. These observations consisted of salivation prior to dosing, soft stool, diarrhea, green fecal discoloration and green staining of the anogenital fur. The incidence of the findings was dose-related in the 100 and 250 mg/kg/day groups.
Soft stool, salivation prior to dosing and clear wet material around the mouth were each observed in one animal on one day during the treatment period in the low dose group. These clinical signs cannot be attributed to administration of the test compound in the 50 mg/kg/day group on the basis of this incidence.
BODY WEIGHTS
Maternal body weights and maternal body weight gain were comparable between the control, low and high dose groups.
In the 100 mg/kg/day group, mean body weights were slightly increased on gestation days 12, 16 and 20, and mean body weight gains were slightly to moderately increased during gestation days 9-12, 16-20, 6-16 and 0-20. The mean values were statistically significant when compared with the control group. These differences were probably due to an unusually large litter size in this group, a condition which was not related to SANTOFLEX 13 administration.
FOOD CONSUMPTION
Mean food consumption, evaluated as g/animal/day and g/kg/day, was comparable between the low dose group and the vehicle control group throughout the study.
In the mid dose group, food consumption was increased with statistical significance during gestation days 9-12 and 16-20 (g/animal/day). This effect corresponds to the body weight increase noted at this dose level and is considered due to an unusually large litter size.
In the 250 mg/kg/day group, mean food consumption was decreased during the first three days of treatment when compared to the vehicle control group; evaluated as g/kg/day this decrease was statistically significant. During the remainder of the treatment period (gestation days 9-12 and 12-16) food consumption was slightly increased when compared to the control group although none of the values were statistically significant during these intervals. After the treatment period (gestation days 16-20), food intake in the 250 mg/kg/day group was significantly increased when evaluated as g/animal/day and g/kg/day.
PATHOLOGY
No morphopathological changes which could be attributed to the administration of SANTOFLEX 13 were observed in any of the treated animals. Rough and firm spleen was noted in one animal in the 100 mg/kg/day group. This type of lesion is not unusual for rats of this strain and age.
GESTATION DAY 20 CESAREAN SECTION DATA
No differences which could be associated with the administration of SANTOFLEX 13 were observed between the control and the treated groups with respect to numbers of viable fetuses, early and late resorptions, fetal sex ratio and fetal weights. A significant increase (p < 0.05) in the mean numbers of viable fetuses, implantation sites and corpora lutea occurred in the 100 mg/kg/day group when compared with the control group. Since ovulation and implantation occur prior to treatment, these differences were not related to SANTOFLEX 13 administration.
FETAL MORPHOLOGICAL EVALUATION
The type of malformations occurring in this study and their frequency were not indicative of a teratogenic response. One fetus in the control group had a diaphragmatic hernia. Two fetuses from two litters in the 100 mg/kg/day group were malformed. The defects observed in this group included one instance of unilateral microphthalmia and one fetus with multiple anomalies. No fetal malformations were observed in the 250 mg/kg/day group.
Small numerical increases (non-statistically significant) in the incidence of a number of skeletal variations were noted in the treated groups. These included an increase in the percentage of fetuses with sternebrae no. 5 and/or 6 unossified and malaligned sternebrae (100 and 250 mg/kg/day groups), sternebrae no. 1, 2, 3 and/or 4 unossified and 27 presacral vertebrae (50, 100 and 250 mg/kg/day groups) and 7th cervical ribs (250 mg/kg/day group). These are common developmental variations in this species and all have been observed to occur with similar incidence in the historical data. The remaining developmental variations occurred with similar frequency between the control group and the treated groups.
Applicant's summary and conclusion
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