Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-405-7 | 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:
- reproductive toxicity, other
- Remarks:
- Carcinogenic effect
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Study report from National Cancer Institute
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Evaluation of Carcinogenicity, Teratogenecity &Mutagenic Activities of Selected Pesticides and Industrial Chemicals. Volume I: Carcinogenic Study
- Author:
- Kotin et al
- Year:
- 1 968
- Bibliographic source:
- National Cancer Institute Division of Cancer Cause &Prevention Carcinogenesis Program Bethesda,1968
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Long term toxicity and carcinogenicity study of test material was performed in mice.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- 4-methoxyphenylacetic acid
- EC Number:
- 203-166-4
- EC Name:
- 4-methoxyphenylacetic acid
- Cas Number:
- 104-01-8
- Molecular formula:
- C9H10O3
- IUPAC Name:
- (4-methoxyphenyl)acetic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): P-methoxy phenyl acetic acid- Molecular formula (if other than submission substance): C9H10O3- Molecular weight (if other than submission substance): 166.175 g/mole - Smiles notation (if other than submission substance): c1(ccc(OC)cc1)CC(O)=O- InChl (if other than submission substance): 1S/C9H10O3/c1-12-8-4-2-7(3-5-8)6-9(10)11/h2-5H, 6H2, 1H3, (H,10,11)- Substance type: Organic- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- No data available
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Details on species / strain selection:
- No data available
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- - Source:Cumberland View Farms- Age at study initiation: 7 dyas - Weight at study initiation: 10-19 gms Fasting period before study:- Housing: Animals were 6 mice to a cage. 2160 mice couli be housed in each room.- Diet (e.g. ad libitum): food , ad libitum- Water (e.g. ad libitum): water, ad libitum - Acclimation period:ENVIRONMENTAL CONDITIONS- Temperature (°C):- Humidity (%):- Air changes (per hr): A dual duct high velocity sy~tem was used for heating, ventilation and air conditioning.Unidirectional air-flow minimized room to room contamination with absolute filtration of all incoming air to remove particulate matter of 0.3 micron diameter or greater.- Photoperiod (hrs dark / hrs light):
Administration / exposure
- Route of administration:
- other: oral administration by stomach tube and after dose is administer through diet.
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Diet(ground feed) and 0.5% gelatin
- Details on exposure:
- oral administration by stomach tube from day 7 to 28 and after dose is administered through diet for 18 months
- Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 18 months
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- 0 and 215 mg/kg bw/day
- No. of animals per sex per dose:
- Total: 1500 mg/kg bw :18 Females0 mg/kg bw :18 Females215 mg/kg bw :18 FemalesPositive controlEthyl carbamate: 24 FemalesAmitrol: 18 FemalesE:thylene imine: 18 FemalesAramite: 18 FemalesDihydrosafrole: 18 FemalesSafrole: 18 Females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The basic concept of the dosage choice was the use of a maximum tolerated dose. The calculated dose was not adjusted to the changing body weight during the three weeks of stomach tubing but a single adjustment was made at the time of conversion from stomach tube to mixture in the feed.- Rationale for animal assignment (if not random): Dosing of individual mice was based on the average weight within a single group and, in the case of repetitive administration, was based on starting weights and not adjusted as the study continued.( An exception to this was the recalculation in the definitive study, at the time of weaning when administration was converted from daily stomach tubing to incorporation in the diet.)
- Positive control:
- Ethyl carbamate, Amitrol, E:thylene imine, Aramite, Dihydrosafrole and Safrole were used as positive control.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes - Time schedule:Daily - Cage side observations checked in table [No.?] were included: Mortality and morbidity were observed. DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: palpated weekly at time of weighing for enlargement of liv,~r and spleen, or any subcutaneous tumor. BODY WEIGHT: Yes - Time schedule for examinations: six animals in each cage were weighed once a week.
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- Gross pathology and histopathology were examined.
- Postmortem examinations (offspring):
- No data available
- Statistics:
- Chi square test &Yates Correction were used
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- No effect on survival of treated female mice were observed as compared to control.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight gain was observed with the increase in duration of 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
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Details on results (P0)
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 215 other: mg/kg
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- mortality
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: No effects on reproductive parameters
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:
- not specified
- Body weight and weight changes:
- not specified
- 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:
- not specified
- 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:
- other: not specified
- Generation:
- other: not specified
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- not measured/tested
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:
- NOAEL was considered to be > 215 mg/kg bw when B6C3F1 female mice by using test material for 18 months.
- Executive summary:
In a reproductive toxicity study, B6C3F1 female mice were treated with test material in the concentration of 0 and 215 mg/kg bw/day in 0.5% gelatin for 7 to 28 day and after dose is administer through diet at 560 ppm for 18 months. Body weight gain was observed with the increase in duration of treatment. No gross pathological changes were observed in treated female mice. In addition, no fibroadenoma and carcinoma mammary gland were observed in treated female mice as compared to control. Therefore, NOAEL was considered to be > 215 mg/kg bw when B6C3F1 female mice by using test material for 18 months.
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.