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EC number: 939-071-6 | CAS number: -
- 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:
- toxicity to reproduction
- Remarks:
- other: 90 d repeated dose toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Follows GLP and OECD 408
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of 4-tert-butylphenol and 1,3- phenylenedimethanamine and 2-({[3-(aminomethyl) benzyl]amino}methyl)-4-tert-butylphenol
- EC Number:
- 939-071-6
- Molecular formula:
- (C10 H14 O . C8 H12 N2 . C H2 O)x
- IUPAC Name:
- Reaction mass of 4-tert-butylphenol and 1,3- phenylenedimethanamine and 2-({[3-(aminomethyl) benzyl]amino}methyl)-4-tert-butylphenol
- Details on test material:
- - Name of test material: Paraformaldehyde, oligomeric reaction products with 4-tert-butylphenol mphenylenebis(methylamine)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: F344/DUCrl
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (Kingston, New York)
- Age at study initiation: Approximately 7 weeks
- Housing: After assignment, animals were housed two per cage in stainless steel cages. Cages had solid floors with corncob bedding and shredded aspen for enrichment. Cages contained a feed crock and a pressure activated lixit valve-type watering system. The following environmental conditions were maintained in the animal room.
- Diet: Animals were provided LabDiet ad libitum.
- Water: ad libitum
- Acclimation period: Upon arrival, the animals were housed two to three per cage in stainless steel cages.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C with a range of 20°C-26°C
- Humidity (%): 50% with a range of 30-70%
- Air changes (per hr): 10-15 times/hour (average)
- Photoperiod (hrs dark / hrs light): 12-hour light/dark (on at 6:00 a.m. and off at 6:00 p.m.)
IN-LIFE DATES: From: November 5,2014 To: February 3 and 4,2015
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DOSE SOLUTION PREPARATION
All dosing solutions were prepared by mixing the test material in propylene glycol (PG) at concentrations of 1.67, 5, or 16.7 mg/ml, and administered at a dose volume of 6 ml/kg body weight to achieve the targeted dose levels.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Mannich base PTBP-MXDA was determined to be soluble in PG at a concentration of 250 mg/ml
- Concentration in vehicle: 1.67, 5, or 16.7 mg/ml
- Lot/batch no. (if required): MKBS5987V. - Details on mating procedure:
- animals were not mated
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 90 or 91 days
- Frequency of treatment:
- once daily seven days/week
- Details on study schedule:
- animals were not mated
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 30, 100 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: A cage-side examination was conducted at least once a day, approximately at the same time each day (usually in the morning).
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Detailed clinical observations (DCO) were conducted on all animals pre-exposure and once per week throughout the study. The DCO was conducted on all animals, at approximately the same time each day according to an established format.
BODY WEIGHT: Yes
- Time schedule for examinations: All rats were weighed pre-exposure, twice during the first week, and weekly thereafter during the dosing period. Body weight gains were calculated relative to day 1.
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
OTHER: more details in section "repeated dose toxicity" - Oestrous cyclicity (parental animals):
- not examined
- Sperm parameters (parental animals):
- not examined
- Litter observations:
- n.a.
- Postmortem examinations (offspring):
- n.a.
- Reproductive indices:
- n.a.
- Offspring viability indices:
- n.a.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Details on results (P0)
Males given 100 mg/kg/day had higher mean relative testes and epididymides weights, that were statistically significant and interpreted to be reflective of the lower body weights of males at this dose level.
Females given 100 mg/kg/day had treatment-related statistically significant lower mean absolute and relative uterus weights, which corresponded to the histopathologic observation of very slight or slight diffuse atrophy of the uterus in 9/10 females at this dose level. Females given 100 mg/kg/day had lower absolute ovaries weights that were statistically significant and interpreted to be reflective of the lower body weights of females at this dose level.
GROSS PATHOLOGY (PARENTAL ANIMALS)
There were no treatment-related gross pathologic observations. All gross pathologic observations were considered to be spontaneous alterations, unassociated with oral gavage administration of Mannich base PTBP-MXDA.
HISTOPATHOLOGY (PARENTAL ANIMALS)
Nine females given 100 mg/kg/day had treatment-related very slight or slight diffuse atrophy of the cervix, uterus, and vagina. The atrophy of the uterus was characterized by diffuse decreased thickness of the endometrial mucosa, endometrial stroma, and tunica muscularis, and corresponded to the lower mean absolute and relative uterine weights at this dose level. The atrophy of the cervix and vagina was characterized by diffuse decreased thickness of the mucosa and fibromuscular wall of these tissues.
More details are given in section "repeated dose toxicity"
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Remarks:
- fertility parameters
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In this 90 d repeated dose toxicity study the follwing effects on reproductive organs were noted:
Females given 100 mg/kg/day had treatment-related statistically significant lower mean absolute and relative uterus weights, which corresponded to the histopathologic observation of very slight or slight diffuse atrophy of the uterus in 9/10 females at this dose level. 9/10 females given 100 mg/kg/day had treatment-related very slight or slight diffuse atrophy of the cervix, uterus, and vagina.
The NOAEL for fertility parameters is 30 mg/kg bw/d.
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