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Diss Factsheets
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EC number: 201-696-0 | CAS number: 86-74-8
- 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:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Screening test, limited documentation, limited number of toxicological endpoints, low number of dams
Data source
Reference
- Reference Type:
- publication
- Title:
- Comparative Developmental Dermal Toxicity and Mutagenicity of Carbazole and Benzo[a]carbazole
- Author:
- Dutson SM, Booth GM, Schaalje GB, Castle RN, and Seegmiller RE
- Year:
- 1 997
- Bibliographic source:
- Environ Toxicol Chem 16 (10), 2113-2117
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA (Prenatal developmental toxicity)
- Principles of method if other than guideline:
- Embryonal/foetal screening during and after intrauterine exposure including perinatal development: Carbazole was dermally administered to pregnant rats from day 0 through day 20 of gestation. Dams were allowed to deliver and all animals including pups were sacrificed at lactation day 4. Dams were examined for signs of toxicity throughout gestation. After sacrifice, uterine content was examined. Pups were weighed after birth and at day 4 of lactation. They were examined externally for gross abnormalities and mortality for each litter was determined on day 1 and 3 of lactation.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Carbazole
- EC Number:
- 201-696-0
- EC Name:
- Carbazole
- Cas Number:
- 86-74-8
- Molecular formula:
- C12H9N
- IUPAC Name:
- 9H-carbazole
- Details on test material:
- - Name of test material (as cited in study report): carbazole (purchased from Sigma Chemical, St. Louis, MO, USA)
- No further information on test substance
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wilmington/MA
- Age at study initiation: 12 - 13 weeks
- Weight at study initiation: 225 - 311 g (females)
ENVIRONMENTAL CONDITIONS
- Temperature_ 64 - 69 °F
- Humidity (%): 40 - 70
- Air changes (per hr): 10 x
- Photoperiod (hrs dark / hrs light):
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- DMSO
- Details on exposure:
- TEST SITE
- Area of exposure: back of animals
REMOVAL OF TEST SUBSTANCE
- Washing (if done): application site was wiped clean with Webril pads
- Time after start of exposure: 6 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5, 25.0, and 250 mg/kg bw each in 1 mL/kg bw DMSO
- Constant volume used: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 1 mL/kg bw
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes, Elizabethan collars for 6 h after administration - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1
- Length of cohabitation: nightly until positive evidence of mating
- Further matings after two unsuccessful attempts: no data
- Verification of same strain and source of both sexes: no data
- Proof of pregnancy: vaginal plug or sperm in vaginal smear; referred to as day 0 of pregnanc - Duration of treatment / exposure:
- From day 0 through day 20 of gestation
- Frequency of treatment:
- daily with exposure time of 6 h
- Duration of test:
- Until lactation day 4 (ca. 26 d)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2.5, 25.0, and 250 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 250 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Dermal irritation (erythema, edema, eschar, and/or dry skin) ranging from slight to moderate was observed at the treatment site of animals in all groups, including the DMSO control group. Severity and frequency were similar in treatment and control group animals. Dermal irritation is not considered to be related with carbazole treatment but to be a result of hygroscopic properties of DMSO.
Applicant's summary and conclusion
- Conclusions:
- In this dermal developmental toxicity study, carbazole did not induce any maternal or developmental toxic effects up to the highest concentration tested (250 mg/kg bw).
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