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EC number: 204-442-7 | CAS number: 121-00-6
- 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:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of butylated hydroxyanisole on the development and functions of reproductive system in rats
- Author:
- Sang-Hee Jeong, Byung-Yong Kim, Hwan-Goo Kang,Hyun-Ok Ku, Joon-Hyoung Cho∗
- Year:
- 2 005
- Bibliographic source:
- Toxicology 208 (2005) 49–62
Materials and methods
- Principles of method if other than guideline:
- The above experiment was performed to assess and evaluate reproductive & developmental effects of the test chemical on Sprague–Dawley rats.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-tert-butyl-4-methoxyphenol
- EC Number:
- 204-442-7
- EC Name:
- 2-tert-butyl-4-methoxyphenol
- Cas Number:
- 121-00-6
- Molecular formula:
- C11H16O2
- IUPAC Name:
- 2-tert-butyl-4-methoxyphenol
- Test material form:
- solid: bulk
- Details on test material:
- - Name of test material: tert-butyl-4-methoxyphenol
- Common name: Phenol, (1,1-dimethylethyl)-4-methoxy-
- Molecular formula: C11H16O2
- Molecular weight: 180.2454 g/mol
- Smiles notation: COc1ccc(O)c(c1)C(C)(C)C
- InChI=1S/C11H16O2/c1-11(2,3)9-7-8(13-4)5-6-10(9)12/h5-7,12H,1-4H3
- Substance type: Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: (P) x wks; (F1) x wks: 7 weeks old
- Diet (e.g. ad libitum):Purina Laboratory Rat Chow ad libitum
- Water (e.g. ad libitum):UV-sterilized tap water, ad libitum
- Acclimation period:1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C):23–25 ◦C
-humidity: 40–60%
- Photoperiod (hrs dark / hrs light):12-h light/dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on mating procedure:
- - Proof of pregnancy: [ sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No Data Available
- Duration of treatment / exposure:
- Males: for a total of 7 weeks
Females: for a total of 10 weeks - Frequency of treatment:
- Once daily
- Details on study schedule:
- Parental generation:
Male rats were treated for total 7 weeks including further 3 weeks of post breeding and F0 female rats were treated for maximum 10 weeks including further 3 weeks of gestation and 3 weeks of lactation period. F0 rats were examined for clinical signs of toxicity, body weight changes and feed and water consumption throughout the dosing period. F0 male rats were sacrificed for the measurement of organ weights, analysis of hormones and cholesterol in serum and examination of sperm motility and morphology and necropsy findings. F0 female rats were sacrificed for the evaluation of necropsy finding, organ weights and hormones and cholesterol contents in serum after weaning.
F1 generation:
Following delivery of the entire litter (postnatal day 0, PND 0), all male and female pups were counted differentially, and examined for clinical signs of toxicity and mortality. During the lactation period, pups were examined for body weight gain and gross morphological abnormalities. Twelve offspring from each sex, litter and treatment group (by selection of 1–2 pups/sex/litter) were treated with each dose of the test chemical from PND 21 until 13 weeks old and another 12 offspring from each sex, litter and treatment group were sacrificed for the evaluation of anogenital distance, necropsy finding or organ weights on PND 21.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 100 or 500 mg/kg
Basis:
- No. of animals per sex per dose:
- Control: 12 males; 12 females
10 mg/kg/day: 12 males; 12 females
100 mg/kg/day: 12 males; 12 females
500 mg/kg/day: 12 males; 12 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No Data Available
Examinations
- Parental animals: Observations and examinations:
- No Data Available
- Oestrous cyclicity (parental animals):
- The estrous cycles were decided under microscope (×200) according to the component ratio of leucocytes, nucleated epithelia and cornified epithelia
- Sperm parameters (parental animals):
- Testes and epididymis were excised and weighed
from each animal. The right cauda epididymis was used for sperm count and left one for sperm motility and sperm head morphology analysis.
-Sperm number was counted using distal cauda of right epididymis, Sperms were immobilized in ice bath for 5 min and then counted under inverted microscope (×100) using hemocytometer - Litter observations:
- No Data Available
- Postmortem examinations (parental animals):
- On necropsy time, thyroid gland and other organs such as adrenal gland, liver, testes, ovary and etc.were taken out for examination
- Postmortem examinations (offspring):
- Thyroid follicular epithelial cells of F1 female and male rats exposed to BHA 100 and 500 mg/kg/day were enlarged in cell height, vacuolated and exfoliated and follicles were decreased in size with sparse colloidal fluid. Any significant histopathological findings were not observed in other organs as liver, testes, ovary and adrenal gland of F1 female and male rats
- Statistics:
- Data are expressed as mean±S.D. Statistical significance of differences was determined using Statistical software (version 5.5) by performing oneway analysis of variance with post hoc comparisons between the vehicle control group and each treatment group
- Reproductive indices:
- Different parameters like Body weight,organ weights, Hormonal changes were analysed
- Offspring viability indices:
- Body weight of F1 pups between control andtreatment groups were examined in both male and female pups on PND 21,
organ weights (liver,Spleens,Testes,adernal )were also examined in ofsprings .
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weights in treated rats were not different significantly from vehicle control group.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Body weights in treated rats were not different significantly from vehicle control group.
- 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:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- Motility, number and head morphology of sperm were not impaired by the test chemical.
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- The ratio of copulation per cohabited pairs was decreased and cohabitation day for copulation took approximately 2 times longer than that of control by the test chemical 500 mg/kg,
Effect levels (P0)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Changes in body and organ weights and in hormonal levels
- Dose descriptor:
- NOEL
- Effect level:
- 10 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects were observed.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- No change in Sperm motility was observed. But, length of sperm head affected by higher doses.
- 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 of F1 pups on PND 0 was not different between control and treatment groups but decreased in both male and female pups on PND 21 by the test chemical in 500 mg/kg/day dose group.
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- Changes were observed in higher dose groups of 100 and 500 mg/kg dose groups.
- Gross pathological findings:
- not specified
- Histopathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Changes in thyriod follicular cells at 500 mg/kg dose group.
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: effects were observed
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The low observed adversed effect level (LOAEL) of the test chemical was found at a dose level of 100 mg/kg bw/day and NOEL value was observed at dose level of 10 mg/kg bw/day in Sprague-Dawley Rats.
- Executive summary:
In a one-generation study, the effect of the test chemical on reproduction and development was investigated in male and female Sprague-Dawley rats. The rats were exposed daily to 0, 10, 100 or 500 mg/kg/day of the test chemical by oral administration. At dose 100 mg/kg/day changes in testosterone level in serum were observed, the weights of sex organs such as vagina, testes and ventral prostate were decreased while the weights of liver, adrenal gland and thyroid gland increased by 100 mg/kg/day of the test chemical. Organ weights of liver, adrenal gland and thyroid gland of F0 rats were increased by 500 mg/kg/day of the test chemical, body weight of F1 offspring was significantly decreased with change in relative weight of liver and brain also. Therefore, LOAEL was considered to be 100 mg/kg/day when male and female Sprague-Dawley rats were exposed to the test chemical at different concentrations.
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