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EC number: 240-357-1 | CAS number: 16245-77-5
- 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:
- reproductive toxicity, other
- Remarks:
- Teratogenicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- experimental data of read across substances
- Justification for type of information:
- Data for the target chemical is summarized based on the structurally similar read across chemicals
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Final Report on the Safety Assessment of Toluene=2,5Diamine, Toluene-2,5 -Diami ne Sulfate, and Toluene-3,4-Diamine
- Author:
- COSMETIC INGREDIENT REVIEW
- Year:
- 1 992
- Bibliographic source:
- Journal of the American College of Toxicology Volume 1 1, Number 4,1992
- Reference Type:
- secondary source
- Title:
- Opinion on: Toluene-2,5-diamine
- Author:
- European Commission (EC) - Scientific Committee on Consumer Products (SCCP)
- Year:
- 2 007
- Bibliographic source:
- the Scientific Committee on Consumer Products, SCCP/1084/07
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Reproductive and developmental toxicity study test chemical was performed on New Zealand White Rabbit
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- 2-methyl-p-phenylenediamine sulfate
- EC Number:
- 210-431-8
- EC Name:
- 2-methyl-p-phenylenediamine sulfate
- Cas Number:
- 615-50-9
- Molecular formula:
- C7H10N2.H2O4S
- IUPAC Name:
- 2-methyl-p-phenylenediamine sulfate
- Test material form:
- solid: particulate/powder
- Details on test material:
- -IUPAC name:2-methyl-p-phenylenediamine sulphate- Name of test material : Toluene-2,5-diamine sulphate- Molecular formula : C7H12N2O4S- Molecular weight : 220.2478 g/mol- Substance type: Organic- Physical state: Off-white powderInChI:1S/C7H10N2.H2O4S/c1-5-4-6(8)2-3-7(5)9;1-5(2,3)4/h2-4H,8-9H2,1H3;(H2,1,2,3,4)Smiles:Cc1cc(ccc1N)N.OS(=O)(=O)O
Constituent 1
- Specific details on test material used for the study:
- RA CAS no : 615-50-9Study reference: Title: Opinion on: Toluene-2,5-diamineFinal Report on the Safety Assessment of Toluene=2,5Diamine, Toluene-2,5 -Diami ne Sulfate, andToluene-3,4-DiamineAuthor: European Commission (EC) - Scientific Committee on Consumer Products (SCCP)COSMETIC INGREDIENT REVIEWBibliographic source: the Scientific Committee on Consumer Products, SCCP/1084/07Journal of the American College of ToxicologyVolume 1 1, Number 4,1992
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on species / strain selection:
- No data available
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on exposure:
- Details on exposurePREPARATION OF DOSING SOLUTIONS: test material dissolved in distilled water DIET PREPARATION- Rate of preparation of diet (frequency):No data available- Mixing appropriate amounts with (Type of food )- Storage temperature of food: No data availableVEHICLE- Justification for use and choice of vehicle (if other than water): - Concentration in vehicle: 0, 10, 25, 50 mg/kg bw/d, - Amount of vehicle (if gavage): No data available- Lot/batch no. (if required): No data available- Purity: No data available
- Details on mating procedure:
- - M/F ratio per cage:No data available - Length of cohabitation: No data available - Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancyNo data available - 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): No data available - Any other deviations from standard protocol:The females were fertilised by natural mating. After coitus HCG was given i.v. to ensure ovulation.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 12 days (from day 6 to 18 of gestation)
- Frequency of treatment:
- once daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- 0, 10, 25, 50 mg/kg bw/d,
- No. of animals per sex per dose:
- Total:820 mg/kg bw/day:1610mg/kg bw/day:1625mg/kg bw/day:1650 mg/kg bw/day:16Positive control group:18
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Parental animals observation and examinationsCAGE SIDE OBSERVATIONS: yes DETAILED CLINICAL OBSERVATIONS: Yes Time schedule: daily BODY WEIGHT: YesTime schedule for examinations: The body weights were determined on days 0, 6, 18 and 28 of gestation.FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data: No data availableWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data Time schedule for examinations: OTHER:
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- Postmortem examinations (Parent Animal)SACRIFICE :On day 28 of gestation the animals were sacrificed,Male animals: All surviving animals [describe when, e.g. as soon as possible after the last litters in each generation were produced.]: No dataMaternal animals: yes All surviving animals [describe when, e.g. after the last litter of each generation was weaned :GROSS NECROPSY: No data available HISTOPATHOLOGY / ORGAN WEIGHTSThe tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively.: macroscopic examination was performed
- Postmortem examinations (offspring):
- Postmortem examinations (offspring)SACRIFICE- The F1 offspring not selected as parental animals and all F2 offspring were sacrificed at [#?] days of age.- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows: the foetuses were dissected and examined for congenital abnormalities and macroscopic changes. The common section parameters were recorded. Half of the foetuses were examined for skeletal and the other half for visceral abnormalities.
- Statistics:
- No data available
- Reproductive indices:
- No data available
- 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 clinical signs were observed.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- 1 female at 10 and 1 female at 25 mg/kg bw/d died, at 50 mg/kg 3 females died presumably because of the intubation procedure.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weights of the females in the dose groups were similar to the controls.
- 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:
- no effects observed
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- Remarks on result:
- other: No effects on reproductive performance
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- The number of the foetuses were not influenced by substance treatment
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The foetal body weights were not influenced by substance treatment
- 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:
- no effects observed
- Description (incidence and severity):
- The frequencies of external abnormalities, visceral malformations and variations as well as skeletal defects exhibited no substance-related changes.
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: no effects on overall developmental parameters
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No Observed Adverse Effect Level (NOAEL) for maternal toxicity and embryotoxicity was considered to be 50 mg/kg/day. When female New Zealand White Rabbit were treated with test chemical orally from day 6 to 18 of gestation.
- Executive summary:
The reproductive and developmental toxicity study of test chemical was performed in female New Zealand White Rabbit. The test material dissolved in distilled water and administered in dose concentration 0, 10, 25, 50 mg/kg bw/d, by oral gavage route from day 6 to 18 of gestation while positive control Vitamin A in rape seed oil in dose concentration 6 mg/kg bw/d given by same route. The females were fertilised by natural mating. After coitus HCG was given i.v. to ensure ovulation. The animals were examined daily for mortality and clinical signs. The body weights were determined on days 0, 6, 18 and 28 of gestation. On day 28 of gestation the animals were sacrificed, the foetuses were dissected and examined for congenital abnormalities and macroscopic changes. The common section parameters were recorded. Half of the foetuses were examined for skeletal and the other half for visceral abnormalities. 1 female at 10 and 1 female at 25 mg/kg bw/d died, at 50 mg/kg 3 females died presumably because of the intubation procedure. No clinical signs were observed. Body weights of the females in the dose groups were similar to the controls. The changes in the incidences of intrauterine death observed were not dose-related. The number and sex of the foetuses as well as the foetal body weights were not influenced by substance treatment. The frequencies of external abnormalities, visceral malformations and variations as well as skeletal defects exhibited no substance-related changes. The positive control (Vitamin A) did not show teratogenicity and only slight embryotoxicity. Hence No Observed Adverse Effect Level (NOAEL) for maternal toxicity and embryotoxicity was considered to be 50 mg/kg/day. When female New Zealand White Rabbit were treated with test chemical orally from day 6 to 18 of gestation.
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