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EC number: 201-933-8 | CAS number: 89-72-5
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- ≥ 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 422) but study period and year of publication not clear (≥ 1997) and only summary available in English.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-sec-butylphenol
- EC Number:
- 201-933-8
- EC Name:
- 2-sec-butylphenol
- Cas Number:
- 89-72-5
- Molecular formula:
- C10H14O
- IUPAC Name:
- 2-(butan-2-yl)phenol
- Details on test material:
- - Name of test material (as cited in study report): o-sec-butylphenol
- Substance type: Mono-alkylphenol
- Analytical purity: 99.15%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crj:CD(IGS)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- Males, 42 days
Females, from 14 days prior to mating to day 3 of lactation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 12, 60, 300 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 13
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Reproductive performance and development of pups studies
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY: no animals died in any group. Salivation after dosing, decrease in activity and incomplete eyelid opening were observed in males and females of the 300 mg/kg group. In addition an ataxic gait was observed in females of the same group. In the 60 mg/kg group, decrease in locomotor activity was observed in a few males early in the administration period.
BODY WEIGHT AND WEIGHT GAIN: no adverse effects were detected in males and females of the 300 mg/kg group.
FOOD CONSUMPTION: no adverse effects were detected in males and females of the 300 mg/kg group.
HAEMATOLOGY: hematological examination of males revealed no adverse effects.
CLINICAL CHEMISTRY: Concentration of total cholesterol was also increased in males given 300 mg/kg.
ORGAN WEIGHTS: an increase in relative liver weight was observed in males and females
GROSS PATHOLOGY
HISTOPATHOLOGY: NON-NEOPLASTIC: hypertrophy of the centrilobular hepatocytes in males of the 300 mg/kg group.
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
HISTORICAL CONTROL DATA (if applicable)
OTHER FINDINGS
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- repeated dose toxicity
- Effect level:
- 12 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- behaviour (functional findings)
- Dose descriptor:
- NOEL
- Remarks:
- repeated dose toxicity
- Effect level:
- 60 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- behaviour (functional findings)
- Dose descriptor:
- NOEL
- Remarks:
- reproductive and developmental toxicity
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: absence of reproductive toxicity
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Repeated dose toxicity
No animals died in any groups. Salivation after dosing, decrease in activity (decreased locomotor activity, adoption of a prone or lateral position, leaning) and incomplete eyelid opening were observed in males and females of the 300 mg/kg group. In addition, ataxic gait was observed in females of the same group. An increase in relative liver weight was observed in males and females of the 300 mg/kg group. On histopathological examination of the liver, hypertrophy of the centrilobular hepatocytes was observed in males of the 300 mg/kg group, whereas this change was not observed in females of the same group. The total cholesterol concentration was increased in the males of the 300 mg/kg group. No adverse effects were detected in terms of food consumption and body weight change in males and females of the 300 mg/kg group. The hematological examination of males revealed no adverse effects of o-sec-butylphenol. In the 60 mg/kg group, decrease in locomotor activity was observed in few males in the early administration period, but not in females. No adverse effects of o-sec-butylphenol at the dose level of 12 mg/kg were found.
The no observed effect dose levels (NOELs) for repeat dose toxicity are considered to be 12 mg/kg/day in males and 60 mg/kg/day in females.
Reproductive and developmental toxicity
No adverse effects were observed on copulation, fertility, maintenance of pregnancy, delivery, and lactation. In addition, o-sec-butylphenol did not affect the viability of neonates, sex ratio, body weight changes, and morphological appearance of pups.
The NOEL for reproductive and developmental toxicity is considered to be 300 mg/kg/day in males, females and offspring.
Applicant's summary and conclusion
- Conclusions:
- Regarding reepated dose toxicity, no adverse effects of o-sec-butylphenol at the dose level of 12 mg/kg in males and 60 mg/kg/day in females were found. Regarding reproductive and developmental toxicity, no adverse effects were observed on copulation, fertility, maintenance of pregnancy, delivery, and lactation. In addition, o-sec-butylphenol did not affect the viability of neonates, sex ratio, body weight changes, and morphological appearance of pups.
- Executive summary:
An OECD 422 combined repeat dose and reproductive/developmental toxicity screening test was performed in rats for o-sec-butylphenol ( Japan Existing Chemical Data Base: study report period not clear, only abstract available in English). With regard to repeat dose toxicity, no animals died in any groups. Salivation after dosing, decrease in activity and incomplete eyelid opening were observed in males and females of the 300 mg/kg group. In addition, an ataxic gait was observed in females of the same group. An increase in relative liver weight was observed in males and females, and hypertrophy of the centrilobular hepatocytes in males of the 300 mg/kg group. Concentration of total cholesterol was also increased in males given 300 mg/kg. No adverse effects were detected on food consumption and body weight change in males and females of the 300 mg/kg group. In the 60 mg/kg group, decrease in locomotor activity was observed in a few males early in the administration period. The NOELs for repeat dose toxicity are considered to be 12 mg/kg/day in males and 60 mg/kg/day in females.
Regarding reproductive and developmental toxicity, no adverse effects were observed on copulation, fertility, maintenance of pregnancy, delivery, and lactation. In addition, o-sec-butylphenol did not affect the viability of neonates, sex ratio, body weight changes, and morphological appearance of pups. NOELs for reproductive and developmental toxicity are considered to be 300 mg/kg/day in males, females and pups.
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