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EC number: 220-618-6 | CAS number: 2835-95-2
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 14 June 1983 to 16 February 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Treatment was performed during the day 5 to 16 instead of until the day scheduled for caeserian section. However, this old study had a method equivalent to the OECD guideline of 1981. This study was not up to modern standard but was still reliable.
- GLP compliance:
- no
- Remarks:
- Not GLP compliance but reviewed with a statement of quality assurance
- Limit test:
- no
Test material
- Reference substance name:
- 5-amino-o-cresol
- EC Number:
- 220-618-6
- EC Name:
- 5-amino-o-cresol
- Cas Number:
- 2835-95-2
- Molecular formula:
- C7H9NO
- IUPAC Name:
- 5-amino-2-methylphenol
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2155/19/11
- Expiration date of the lot/batch: not specified
- Purity test date:not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored at room temperature in a dark area away from heat
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was prepared as suspension. For preparation and during administration to the animals, each formulation mixed using a magnetic stirrer. Separate preparations were made for each dose level.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: not specified
- Weight at study initiation: 170 to 230g
- Fasting period before study: not specifed
- Housing: solid floor macrolone cages type II with stainless steel lids (dimensions 260 x 200 mm)
- Diet and water (e.g. ad libitum): Throughout the study the rats were allowed free access to food. The basic diet used was obtained in pelleted form, Ssniff R. Tap water was available ad libitum from plastic water bottles attached to each cage.
- Acclimation period: seven days prior the start of mating
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%): 40 to 70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light):12 hours / 12 hours
IN-LIFE DATES: From: 14 June 1983 To: 1 August 1983
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% CMC
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test article was prepared as suspension. For preparation and during administration to the animals, each formulation mixed using a magnetic stirrer. Separate preparations were made for each dose level.
VEHICLE
- Justification for use and choice of vehicle (if other than water): no specified
- Concentration in vehicle: 2, 6, 18 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1 Male for 4 females
- Length of cohabitation: overnight
- Further matings after two unsuccessful attempts: no
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- From the day 6 to 15
- Frequency of treatment:
- once daily
- Duration of test:
- until the day 20 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 20 mg/kg bw/day (nominal)
- Dose / conc.:
- 60 mg/kg bw/day (nominal)
- Dose / conc.:
- 180 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 25 animals were used per condition (expet for positive control : 23 animals)
- Control animals:
- yes
- yes, concurrent vehicle
- other: positive control
- Details on study design:
- - Dose selection rationale: not specified
- Rationale for animal assignment (if not random): randomly
Examinations
- Maternal examinations:
- APPEARANCE, BEHAVIOUR AND GENERAL OBSERVATIONS All animals were examined at least once daily for signs of ill-heath, toxicity and behavioural change. Daily mortality checks were also performed.
BODYWEIGHT: The bodyweight of each mated female rat was recorded on days 0, 6, 15 and 20 (respectively 19) of gestation. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No - Statistics:
- WHere appropriate the data were analysed using Kruskal Wallis test, Wilcoxin's test, Fisher's randomisation testn Analysis of Variance and the Chi-square method
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical changes during gestation were observed in all groups
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No difference was observed between tested and control group.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There was no treatment related changes in all groups. Dilatations of the renal pelvis were observed in all groups including control.
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- In treated groups, the mean number of corpora lutea and the mean number of implantations per dam were comparable with the control group. The incidence of intra-uterine deaths was not affected by treatment with the test substance.
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- Both litter was comparable to all groups including the control
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 180 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- clinical signs
- gross pathology
- maternal abnormalities
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- no difference between treated and control groups was observed.
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Visceral variations (dilatation of the renal pelvis) were observed in group II (five fetuses), group III (five fetuses) and group IV (two fetuses). The occurence of these visceral variations was considered to be unrelated to treatment with test substance, because dilatations of renal pelvis were also observed in the control group and in historical groups of similar studes with the same strain of rats.
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Positive Control : Vitamin A Acid was sued as positive control. Administration of 15 mg/kg produced a marked teratogenic effect. The majority of malformed foetuses showed exencephaly.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 180 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- external malformations
- skeletal malformations
- visceral malformations
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In this rat teratogenicity study, no treatment-related changes were noted in any of the dose groups of 20, 40 and 180 mg /kg bw/day administered from day 6 to day 15 post coitum. Consequently, a NOAEL of 180 mg/kg bw for maternal and embryo-foetal effects is determined for 4-amino-2-hydroxytoluene
- Executive summary:
The present study was performed in order to assess the potential teratogenicity effect when administered orally to female pregnant rats. The method was similar to OECD 414 guideline.
Mature male and female Sprague-Dawley rats were housed together, and day 0 of pregnancy was defined as the day on which vaginal sperm were detected. Females were then housed separately and dosed by gavage during the embryonic period GD 6 -15. Treated rats were observed daily and weighed on GD 0, 6, 15 and 20. On GD 20, dams were euthanized with CO2, the uterine horns were removed and numbers and conditions of foetuses recorded Half the foetuses were fixed in Bouin’s solution for examination of soft tissue, and the other half were fixed in ethanol and stained with Alizarin Red S for examination of skeletal effects.
In this rat teratogenicity study, no treatment-related changes were noted in any of the dose groups of 20, 40 and 180 mg /kg bw/day administered from day 6 to day 15 post coitum. Consequently, a NOAEL of 180 mg/kg bw for maternal and embryo-foetal effects is determined for 4-amino-2-hydroxytoluene
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