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EC number: 202-426-4 | CAS number: 95-51-2
- 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
- Study period:
- 191-04-23 to 1992-04-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- ; adopted 1981-05-12
- Deviations:
- yes
- Remarks:
- ; exposure to test item from day 6 to 15 of pregnancy
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- ; exposure to test item from day 6 to 15 of pregnancy
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-chloroaniline
- EC Number:
- 202-426-4
- EC Name:
- 2-chloroaniline
- Cas Number:
- 95-51-2
- Molecular formula:
- C6H6ClN
- IUPAC Name:
- 2-chloroaniline
- Details on test material:
- - Name of test material (as cited in study report): o-Chloraniline
- Physical state: yellow-orange, clear liquid
- Analytical purity: 99.6 % (IR spectroscopy)
- Impurities (identity and concentrations):
<0.01 % cyclohexylamine
<0.01 % N-isopropylaniline
<0.01 % 2-chloro-N-Isopropylaniline
0.08% aniline
<0.01% 2-Isopropylaniline
<0.01% o-nitrochlorobenzene
0.24% p-chloroaniline
<0.01% m-chloroaniline
<0.01% 2,4-dichloroaniline
<0.01% 2,5-dichloroaniline
<0.01% 2,3-dichloroaniline
<0.01% 2,3-dichloroaniline
<0.01% o-phenylendiamine
0.03 % unknown impurities
- Purity test date: 24 Apr 1991
- Lot/batch No.: Lagerkessel 15/ 594 488
- Stability under test conditions: stable and homogen throughout the test period
- Storage condition of test material: 3-7°C, dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Bor:WISW (SPF Cpb)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: 2-3 months
- Weight at study initiation: male >300 g; nulliparous female 186-245 g
- Fasting period before study:
- Housing: groups of females per macrolon III cage before pairing and individual housing in macrolon cages II from day 0 p.c. on, male rats were housed individually in macrolon II cages, cages were changed three times per week, animals and cages marked individually
- Bedding: wood chips, Ssniff
- Diet : ad libitum; Altromin 1324
- Water: ad libitum; tap water
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 33-90
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
0 mg/mL
2 mg/mL
10 mg/mL
50 mg/mL
Dosing solutions were tested for homgenicity and stability and kept in the dark at RT.
VEHICLE
- Justification for use and choice of vehicle (if other than water): polyethylene glycol enhances solubility and bioavailability of the test substance
- Amount of vehicle (if gavage): 5 mL/kg bw
- Source: BASF - Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/2 (not mor than 2 matings per male)
- Length of cohabitation: overnight
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 6 - 15 d
- Frequency of treatment:
- daily
- Duration of test:
- day 0 to day 20 of pregnancy
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10, 50, 250 mg/kg body weight (in 5 ml/kg Polyethylen glycol)
Basis:
actual ingested
- No. of animals per sex per dose:
- control group and dose groups 10 mg/kg and 50 mg/kg: 25 dams
250 mg/kg dose group: 28 dams - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sex: female
Duration of test: until 20 d
Examinations
- Maternal examinations:
- food consumption, body weight, spleen weight and histopathology, clinical signs of toxicity
- Ovaries and uterine content:
- number of corpora lutea, implantation sites, weight of uteri, weight and appearance of placenta, number of alive and dead fetuses, sex of alive fetuses
- Fetal examinations:
- visible morphological changes, visceral changes, (according to Wilson and Dawson)
- Statistics:
- rank sum test (Wilcoxon): body weight, number of fetuses with malformations per dam
Fisher-test: fertility and gravity rate
CHi square for: number of fetuses with different malformations, number of early and late resorptions, number of different sexes, preimplantation loss
F-test and t-test for the other parameters - Historical control data:
- yes
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
no mortality; at 250 mg/kg: tremor following application, body weight gain and food consumption reduced; at 50 and 250 mg/kg: absolute spleen weight increased, increased hyperaemia, iron content and extramedullary haematopoesis;
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
teratogenic effects:
at 10, 50 mg/kg: no significant effects;
at 250 mg/kg: significant increase of late resorptions, number of viable pups/litter significantly decreased;
embryotoxic effects:
at 50, 250 mg/kg: necrotic placenta lining;no effects on development of skeletal system;
at 250 mg/kg: increased number of spontaneous malformations.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- 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
Applicant's summary and conclusion
- Executive summary:
Bartmann, K and Holzum, B (1993)
2 -Chloroaniline was tested by oral gavage for developmental toxicity study in rats according to OECD 414. the dams were treated daily with either 0, 10, 50 or 250 mg 2-chloroaniline in polyethylene glycol / kg body weight from day 6 to 15 of pregnancy. One day prior to delivery the uteri were removed and the fetuses as well as the uteri examinated. No mortality was observed in the dams. the 250 mg/ kg dose group displayed signs of toxicity like tremor, reduced food intake and reduced body weight gain. In the 50 and 250 mg/kg dose group the spleen weights were increased, most probably due to increased hematopoesis induced by methemoglobin formation. Beginning necrosis was more evident in these dose groups as well, probably caused by reduced oxygen supply. In the highest dose group the number of late resorptions and the number of spontaneous malformations increased and the number of fetuses decreased. Evidence for a specific teratogenic effect of 2-chloroaniline is lacking. The observed embryotoxicity
is in line with the observed maternal toxcicity. The maternal NOAEL was 10 mg 2-chloroaniline per kg body weight per day the fetal NOAEL was 50 mg 2-chloroaniline per kg body weight per day.
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