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EC number: 207-803-7 | CAS number: 495-54-5
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the teratogenic potential of the Oxidative dyes 6-chloro-4-nitro-2-aminophenol And o-chloro-p-phenylenediamine
- Author:
- J. C. PICCIANO, W. E. MORRIS and B. A. WOLF
- Year:
- 1 984
- Bibliographic source:
- Fd. Chem. Toxic. Vol. 22, no. 2, pp. I47 149, 1984
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The present study was conducted to determine the reproductive toxicity potential of 2-chloro-p-phenylenediamine (o-chloro-p-PD) (CAS No.- 615-66 -7) when administered orally to rats.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-chloro-p-phenylenediamine
- EC Number:
- 210-441-2
- EC Name:
- 2-chloro-p-phenylenediamine
- Cas Number:
- 615-66-7
- Molecular formula:
- C6H7ClN2
- IUPAC Name:
- 2-chlorobenzene-1,4-diamine
- Details on test material:
- - Name of test material (as cited in study report): o-chloro-p-phenylenediamine (o-chloro-p-PD)
- Molecular formula (if other than submission substance): C6H7N2Cl
- Molecular weight (if other than submission substance): 142.59 g/mole
- Substance type: Organic
- Physical state: Solid
- Impurities (identity and concentrations): No data available
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 2-chloro-p-phenylenediamine (o-chloro-p-PD)
- Molecular formula: C6H7N2Cl
- Molecular weight:142.59 g/mole
- Substance type: Organic
- Physical state: Solid
- Impurities (identity and concentrations):No data available
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Breeding Laboratories, Wilmington,MA
- Age at study initiation: (P) x wks; (F1) x wks : No data available
- Weight at study initiation: P - 225-250 g
- Fasting period before study: No data available
- Housing: Individually housed
- Diet (e.g. ad libitum): Purina Laboratory Rodent Chow, ad libitum
- Water (e.g. ad libitum):Water, ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- propylene glycol
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: o-chloro-p-phenylenediamine was dissolved in propylene glycol before administration.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Propylene glycol
- Concentration in vehicle: 0, 100, 200 and 400 mg/kg/day
- Amount of vehicle (if gavage): 10 ml/kg
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- - M/F ratio per cage:1 : 2 ratio
- Length of cohabitation:No data available
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy: Sperm plug or the presence of sperm in a vaginal smear referred to as day 0 of pregnancy.
- After … days of unsuccessful pairing replacement of first male by another male with proven fertility. No data available
- Further matings after two unsuccessful attempts: [no / yes (explain)]: No data available
- After successful mating each pregnant female was caged (how): Caged separately
- Any other deviations from standard protocol: No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 days
- Frequency of treatment:
- Daily
- Details on study schedule:
- Details on study schedule
- F1 parental animals not mated until [...] weeks after selected from the F1 litters: No data available
- Selection of parents from F1 generation when pups were [...] days of age. No data available
- Age at mating of the mated animals in the study: [...] weeks
(Explain how study was performed on perents and offspring separately whatever information we have): No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0,100, 200 and 400 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Total : 53
10 ml/kg : 20 female
100 mg/kg/day : 11 female
200 mg/kg/day : 11 female
400 mg/kg/day : 11 female
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- Mortality , general health and condition and body weight were observed.
- Oestrous cyclicity (parental animals):
- Any irregularities in the estrous cycle were investigated.
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- Litter was observed for survival rate, body weight, number of litter, sex ratio and general appearance were examined.
- Postmortem examinations (parental animals):
- Gross abnormalities were examined.
Number of implantation sites and number of resorptions were also examined. - Postmortem examinations (offspring):
- Gross, visceral and skeletal anomalies in fetuses were observed.
- Statistics:
- Weight changes, the number of fetal implantations, fetal weights and the fetal sex ratio were analyzed by using Student's t test, The numbers of foetal resorptions and abnormal foetuses were compared by chi square analysis and vehicle control data were combined after an analysis of variance.
- Reproductive indices:
- Fertility index, gestation index, delivery index and implantation index were examined.
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No abmormalities were observed in treated female rats.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality were observed in treated female rats.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight and weight gain: Mean weight gain was decreased on 6-16 day in 200 mg/kg/day and on 6-20 day in 400 mg/kg/day treated female rats.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- No effect were observed on reproductive performance of treated animals as compare to control.
No change were observed in fertility index, gestation index and implantation index of treated female rat as compare to control. Statistically significant increase in the number of resorptions were observed in 400 mg/kg/day treated rats.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No effect on survival, clinical sign, body weight, Reproductive function and Reproductive performance
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (P1)
- Critical effects observed:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight: Weight of both male and female fetuses were significantly decreased as compare to control
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- No significant differences were observed in number of abnormal foetuses and the types of gross and skeletal anomalies as compare to contol.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- No visceral anomalies were ovbserved in fetuses of treated female rats.
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
No significant differences in the male:female sex ratio were observed as compare to control.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 200 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No effect on survival, body weight, Gross pathology and Histopathology
Target system / organ toxicity (F1)
- Critical effects observed:
- no
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 100 mg/kg/day for F0 generation and 200 mg/kg/day for F1 generation when female rat were exposed to 2-chloro-p -phenylenediamine (o-chloro-p-PD).
- Executive summary:
In a reproductive toxicity study, female Sprague-Dawley rat were exposed 2-chloro-p-phenylenediamine (o-chloro-p-PD) orally in the concentration 0, 100, 200 and 400 mg/kg/day. In the parental generation, decreased in mean body weight were obsrved in 200 and 400 mg/kg/day treated rat as compared to control . In addition,significant increase in the number of resorptions were observed in female rat. Effect on fetal weight was observed when treated with 400 mg/kg/day. Therefore, NOAEL is considered to be 100 mg/kg/day for F0 generation and 200 mg/kg/day for F1 generation when rats are exposed to 2-chloro-p-phenylene diamine (o-chloro-p-PD) orally for 10 days.
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