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EC number: 210-441-2 | CAS number: 615-66-7
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Under the condition of the study, the 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).
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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
- 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
- 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 - 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 - 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 - 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
- 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
- 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: 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. - 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
- Critical effects observed:
- no
- Remarks on result:
- not measured/tested
- Critical effects observed:
- not specified
- 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
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- 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
- Critical effects observed:
- no
- Remarks on result:
- not measured/tested
- Critical effects observed:
- not specified
- Reproductive effects observed:
- no
- 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.
Reference
No significant differences in the male:female sex ratio were observed as compare to control.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The data is Klimicsh 2 and from peer-reviewed journal.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Various studies has been investigated for reproductive toxicity to a greater or lesser extent for the test chemical 2-chloro-p-phenylenediamine (CAS No.- 615-66-7) along with its structurally similar read across substances 2,4,6-trichloroaniline (CAS No.- 634-93-5) and 3,4-dichloroaniline (CAS No : 95-76-1). The studies are summarized as below:
The present study was undertaken by J. C. Picciano et al. (Food and Chemical Toxicology. Vol. 22, no. 2, pp. I47 149, 1984)to determine the reproductive toxicity potential of 2-chloro-p-phenylenediamine(CAS No.- 615-66-7), female Sprague-Dawley rat were exposed 2-chloro-p-phenyle nediamine (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-phenylenediamine (o-chloro-p-PD) orally for 10 days.
In addition, reproductive toxicity study published by SRC Inc (2010), male and female rats were exposed to 2,4,6-trichloroaniline (CAS No.- 634-93-5) in the concentrations of 0, 0.3, 3 and 29 mg/kg/day. The results showed that 2,4,6 trichloroaniline is toxic at higher doses. Toxic changes were observed as decreased in weight gain, increased numbers of hypochromic RBCs and doubled levels of methemoglobin, anisocytosis, poikilocytosis, reticulocytosis, hypochromia and presence of Heinz bodies in the RBCs and decreased in SDH and LDH activities in liver and the kidney of 29 mg/kg/day treated rat. Increased relative weights of brain and decreased liver weight. In addition, Degenerative changes and evidence of hemorrhage in the myocardium, kidneys, liver, spleen and brain in 29 mg/kg/day treated rats. Decreased numbers of fetuses/dam and massive hematomas were observed in abdominal cavities of 3 mg/kg/day treated rat of F1 generation. In F1 generation, Pre and post implantation fetal mortality were also observed in 3 mg/kg/day treated rat. Therefore, the NOAEL was considered to be 0.3 mg/kg/day for both F0 and F1 generation when rats were treated with 2, 4, 6 trichloroaniline orally for 6 months.
Moreover, the study was designed and published by U.S. Environmental Protection Agency (U.S. Environmental Protection Agency TSCA, NTIS Technical Report : OTS0600391, 2008) to investigate the reproductive effects of 3,4-Dichloroaniline in Charles River CrI:CD BR rats. The substance3,4-dichloroaniline (CAS No : 95-76-1) was administered orally by gavage at three doses 0, 5, 25 and 125 mg/kg - to groups of pregnant Charles River CrI:CD BR rats. No statistically significant or toxicologically relevant adverse effects on any of the maternal reproductive parameters studied were observed in the 5 mg/kg dose groups. The test article did, however, produce a slight increase in absorptions and consequently in post-implantation loss at 125 mg/kg. No effects observed on fetuses. Hence, NOAEL for maternal toxicity study was considered to be 5 mg/kg bw/day whereas NOAEL for fetotoxicity study was considered to be 25 mg/kg bw/day in Charles River CrI:CD BR rats when 3,4-dichloroaniline was administered orally by gavage.
Based on the above mentioned studies for target substance and to its read across substance and by comparing these with the CLP criteria, it can be concluded that no adverse effects was observed, therefore the substance 2-chloro-p-phenylenediamine (CAS No.- 615-66-7) cannot be classified as reproductive toxicant.
Effects on developmental toxicity
Description of key information
Under the condition of the study, the NOAEL was considered to be 100 mg/kg/day for maternal study and 200 mg/kg/day for teratogenicity study when female rat were exposed to 2-chloro-p-phenylenediamine (o-chloro-p-PD).
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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.
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The present study was conducted to determine the teratogenic potential of 2-chloro-p-phenylenediamine (o-chloro-p-PD) (CAS No.- 615-66 -7).
- GLP compliance:
- not specified
- 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 - Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Sex: Female
- 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 - Analytical verification of doses or concentrations:
- not specified
- 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 - Duration of treatment / exposure:
- 10 days
- Frequency of treatment:
- Daily
- Duration of test:
- 10 days
- 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
- Maternal examinations:
- Mortality , general health and condition and body weight and gross abnormalities were examined
- Ovaries and uterine content:
- Number of implantation sites and number of resorptions were also examined.
- Fetal examinations:
- Litter was observed for survival rate, body weight, number of litter, sex ratio, general appearance, 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.
- Indices:
- Fertility index, gestation index, delivery index and implantation index were examined.
- Historical control data:
- No data available
- 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):
- 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
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Reproductive function:
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
Reproductive performance:
No effect were observed on reproductive performance of treated animals as compare to control. - Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Mortality :
No mortality were observed in treated female rats
Clinical signs:
No abmormalities were observed in treated female rats
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.
Reproductive function:
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
Reproductive performance:
No effect were observed on reproductive performance of treated animals as compare to control. - Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: No adverse effect on survival, clinical sign, body weight, reproductive performance.
- Abnormalities:
- not specified
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Weight of both male and female fetuses were significantly decreased as compare to control
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- No significant differences in the male and female sex ratio of fetuses were observed as compare to control
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Description (incidence and severity):
- No significant differences were observed in number of abnormal foetuses and the types of gross anomalies in treated female rat as compare to contol.
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- No significant differences were observed in number of abnormal foetuses and the types of skeletal anomalies in treated female rat as compare to contol.
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- No significant differences were observed in number of abnormal foetuses and the types of visceral anomalies in treated female rat as compare to contol.
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects: no effects
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- no
- Conclusions:
- NOAEL was considered to be 100 mg/kg/day for maternal study and 200 mg/kg/day for teratogenicity study when female rat were exposed to 2-chloro-p-phenylenediamine (o-chloro-p-PD).
- Executive summary:
In a teratogenicity study, female Sprague-Dawley rat were exposed to 2-chloro-p-phenylenedia mine (o-chloro-p-PD) orally in the concentration of 0, 100, 200 and 400 mg/kg/day. In the parental generation, decreased in mean body weight were observed 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 male and female fetal weight was observed when treated with 400 mg/kg/day. Therefore, NOAEL was considered to be 100 mg/kg/day for maternal study and 200 mg/kg/day for teratogenicity study when rats are exposed to 2-chloro-p-phenylenediamine (o-chloro-p-PD) orally for 10 days.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The data is Klimicsh 2 and from peer-reviewed journal.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a teratogenicity study conducted by J. C. Picciano et al. (Food and Chemical Toxicology. Vol. 22, no. 2, pp. I47 149, 1984), female Sprague-Dawley rat were exposed to 2-chloro-p-phenylenediamine (o-chloro-p-PD) orally in the concentration of 0, 100, 200 and 400 mg/kg/day. In the parental generation, decreased in mean body weight were observed 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 male and female fetal weight was observed when treated with 400 mg/kg/day. Therefore, NOAEL was considered to be 100 mg/kg/day for maternal study and 200 mg/kg/day for teratogenicity study when rats are exposed to 2-chloro-p-phenylenediamine (o-chloro-p-PD) orally for 10 days.
Thus, on the basis of above available study and by comparing these with the CLP criteria, it can be concluded that no adverse effects on development of the offspring was observed. Therefore the substance 2-chloro-p-phenylenediamine(CAS No.- 615-66-7) can be regarded as not owing a significant potential for developmental toxicity.
Justification for classification or non-classification
Based on the available data for the assessment of reproductive toxicity and developmental toxicity and following CLP Regulation EC No. 1272/2008 no classifi cation of 2-chloro-p-phenylenediamine(CAS No.- 615-66-7) as reproductive toxicant is warranted.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.