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EC number: 202-448-4 | CAS number: 95-76-1
- 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:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3,4-dichloroaniline
- EC Number:
- 202-448-4
- EC Name:
- 3,4-dichloroaniline
- Cas Number:
- 95-76-1
- Molecular formula:
- C6H5Cl2N
- IUPAC Name:
- 3,4-dichloroaniline
- Details on test material:
- - Name of test material (as cited in study report): 3,4-dichloroaniline
- Physical state: solid
- Analytical purity: 99.2 %
- Lot/batch No.: 597331
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River Crl:CD BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles river Breeding laboratories, portage, MI
- Age at study initiation: older than 10 weeks, younger than 18 weeks (females) or 1 year (males)
- Weight at study initiation: more than 180 g (females, 250 g (males)
- Housing: individually
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: minimum 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): climate control
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1989-10-03 To:1989-11-03
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
-
VEHICLE
- Justification for use and choice of vehicle (if other than water): insoluble in water
- Concentration in vehicle: 0.05, 0.25, 1,25 %
- Amount of vehicle (if gavage): 10 mL/ kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- HPLC
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/2
- Length of cohabitation: over night
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- from day 6 to day 15
- Frequency of treatment:
- daily
- Duration of test:
- day 0 to day 20 of gestation
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
5 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
25 mg/kg bw
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
125 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 28 dams/ dose
- Control animals:
- yes
- Details on study design:
- Sex: female
- Dose selection rationale: range finding test indicated severe maternal toxicity when dams were treated with 175, 250 or 325 mg/kg bw
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- 5 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- 25 mg/kg bw/day
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
In general, 3,4 -dichloroaniline was well tolerated and there were no overt adverse clinical signs of toxicity. However, body weight gains and food consumption were significantly reduced during treatment for both the 25 and 125 mg/kg groups. Dose levels of 5 and 25 mg/kg produced no statistically significant or toxicologically relevant adverse effects on any maternal reproductive or fetal parameter studied. There was no evidence of embryotoxicity (increased resorption), fetotoxicity (reduced growth/ delayed ossification), nor any increase in either the fetal or litter incidence of malformations for these groups. Although not statistically significant, there was a slight increase in resorption and consequently, post-implantation loss for the 125 mg/kg group which is considered treatment-related. The high-dose also promoted delayed ossification of several skeletal elements.
Applicant's summary and conclusion
- Executive summary:
Clemens and Hartnagel, 1990
In the teratogenicity study 3,4 -Dichloroaniline, administered to gravid rats at doses up to and including 25 mg/kg, is devoid of any toxicity, and/ or teratogenicity. Because of significantly reduced body weight gains and food consumption at dose levels of 25 and 125 mg/ kg a dose of 5 mg/kg is considered the maternal NOEL. As a result of a significant increase in delayed ossification of a few skeletal elements and an increase in the incidence of resorption and post-implantation loss at 125 mg/kg, a dose of 25 mg/kg is considered the NOEL for developmental toxicity.
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