Registration Dossier
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EC number: 202-870-9 | CAS number: 100-61-8
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across.
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of 60 Chemicals in a Preliminary Developmental Toxicity Test
- Author:
- Hardin B.D., Schuler R.L., Burg J.R., Booth G.M., Hazelden K.P., MacKenzie K.M., Piccirillo V.J. and Smith K.N.
- Year:
- 1 987
- Bibliographic source:
- Teratogenesis, Carcinogenesis, and Mutagenesis 7 : 29-48
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Exposure of female pregnant mice for 8 days for gestation day (gd) 6 to 13. Dosages were based on range-finders with non-pregnant mice. Data colleced were limited to daily observations,
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Aniline
- EC Number:
- 200-539-3
- EC Name:
- Aniline
- Cas Number:
- 62-53-3
- Molecular formula:
- C6H7N
- IUPAC Name:
- aniline
- Reference substance name:
- 100-0 1-6
- IUPAC Name:
- 100-0 1-6
- Reference substance name:
- N,N-dimethylaniline
- EC Number:
- 204-493-5
- EC Name:
- N,N-dimethylaniline
- Cas Number:
- 121-69-7
- Molecular formula:
- C8H11N
- IUPAC Name:
- N,N-dimethylaniline
- Details on test material:
- Aniline
Aniline, p-nitro
Aniline, N,N-dimethyl
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- For dose-finding studies, in general virgin female mice were group housed (five per cage) throughout treatment, and observation periods.
An abbreviated quarantine of about 5 days was applied to approximate that in the reproductive studies. At the end of this quarantine, any animals judged unsuitable for the study were discarded. Remaining mice were weighed and randomly assigned to experimental groups with stratification by body weight.
In the reproductive phases, time-mated (primigravida) mice were received from the vendor on dg 1-3 (vaginal plug = day 0). On gd 6, mice judged unsuitable for the study were discarded. Remaining mice were weighed and randomly assigned to control and experimental groups with stratification by body weight. Mice were singly housed in solid-bottom boxes. Nesting material (Bed-0-Cobs, Sani-chip, San-i-cel, or sterilized white wood shavings) was changed once weekly, but no bedding change was made later than gd 17 to avoid disturbing mice near parturition.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Treatments were administered by gavage using a standard dosing volume of 10 ml/kg body weight. For the reproductive phase, the LD10 predicted on the basis of dose-finding results was the single dose used.
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- No details, mice were already pregnant at arrival (gd: 0-2).
- Duration of treatment / exposure:
- 8 days of treatment (gd 6-13)
- Frequency of treatment:
- Once daily.
- Duration of test:
- Total duration of the experiment: 17 days (until gd 22)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
Aniline
Basis:
actual ingested
560 mg/kg/d
- Remarks:
- Doses / Concentrations:
Aniline, p-nitro
Basis:
actual ingested
1200 mg/kg/d
- Remarks:
- Doses / Concentrations:
Aniline, N,N-dimethyl
Basis:
actual ingested
365 mg/kg/d
- No. of animals per sex per dose:
- Females: 50
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOEL
- Effect level:
- 560 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- Aniline
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOEL
- Effect level:
- 1 200 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- p-nirtoaniline
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOEL
- Effect level:
- 365 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- N,N-dimethylaniline
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOEL
- Effect level:
- 560 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- Aniline
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- LOEL
- Effect level:
- 1 200 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- p-nitroaniline
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOEL
- Effect level:
- 365 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- N,N-dimethylaniline
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes. Remark: See Table 1
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1: Test results
Maternal | Pups | ||||||||
Substance | Dose | dead/N | B.W. change | Viable litters | Liveborn | % survival | Birth | Weight | |
(mg/kg/d) | (g) | per litter | weight (g) | gain (g) | |||||
Aniline | 560 | 6/50 | 6.7 | 25/25 | 10.3 | 94 | 1.5 | 0.9 | |
p-Nitroaniline | 1200 | 21/50 | 3.6 | 11/16 | 5.0 | 78 | 1.5 | 0.8 | |
N,N-dimethylaniline | 365 | 3/50 | 8.2 | 36/37 | 8.6 | 98 | 1.7 | 1.1 | |
Control | (corn-oil) | 0/50 | 9.0 | 41/41 | 9.5 | 99 | 1.6 | 1.1 | |
See the original publication for the standard deviations. | |||||||||
Figures in red are significantly different from the respective control values. |
The concentrations tested for Aniline and p-Nitroaniline induced significant effects on maternal body weight, while the concentration tested for p-Nitroaniline induced significant mortality of pups.
Applicant's summary and conclusion
- Conclusions:
- The no effect levels for embryonal and fetal development of rats exposed in utero to aniline and p-nitroaniline are below concentrations of 560 and 1200 mg/kg bw/d, respectively. The NOEL of N,N-dimethylaniline for teratogenic effects in rats was at 365 mg/kg bw/d.
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