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EC number: 201-842-3 | CAS number: 88-60-8
- 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: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study, carried out by Hatano Research Institute, Food and Drug Safety Center (JAPAN)
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity Testing Report of Environmental Chemicals 7, 179-181
- Author:
- MHW (Ministry of Health and Welfare), Japan .
- Year:
- 1 999
- Bibliographic source:
- cited: OECD SIDS Initial Assessment Report, Boston 20-25th Oct. 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 422
- Principles of method if other than guideline:
- Type: Toxicity to Reproduction
Method : OECD Preliminary Reproduction Toxicity Screening Test (TG 422) - GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- 6-tert-butyl-m-cresol
- EC Number:
- 201-842-3
- EC Name:
- 6-tert-butyl-m-cresol
- Cas Number:
- 88-60-8
- Molecular formula:
- C11H16O
- IUPAC Name:
- 2-tert-butyl-5-methylphenol
- Details on test material:
- Produced by Sumitomo Chemical, Lot No.1271012. Purity 99.23%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Male: for 42 days;
Female: for 40-48 days from 14 days prior to mating to the 3 day of lactation - Frequency of treatment:
- Daily
- Duration of test:
- Terminal killing: Male; day 43 Female; day 4 of lactation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2.5, 12.5, 60 mg/kg/day (in corn oil)
Basis:
nominal conc.
- No. of animals per sex per dose:
- No. of animals per sex per dose: 13 per sex per dose group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- [Study Design]
The animals were sacrificed on the day 4 of lactation for females. Females with no delivery were killed on the day 25 of pregnancy. *Satellite groups and reason they were added: none *Mating procedure: Male / female per cage; 1/1, length of cohabitation; at most 14 days, until proof of copulation (formation of vaginal plug or sperm detection in vagina) - Statistics:
- Statistical methods: Dunnett's or Scheffe's test for continuous data and Chisquare test for quantal data
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 12.5 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: for maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 12.5 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: for pups toxicity
Observed effects
*Body weight: suppression of body weight gain was observed on the day14 of pregnancy and the day 4 of lactation in the 60 mg/kg group.
*Food consumption: Decrease in food consumption was observed during lactation period in 60 mg/kg group.
*Pups data: Grossly visible abnormalities : no significant effect was observed.
Any other information on results incl. tables
NOAEL;
12.5 mg/kg/day for maternal toxicity
12.5 mg/kg/day for pups toxicity.
*Maternal data with dose level (with NOAEL value):
Decrease tendencies, not significant, in number of corpora lutea and number of implantation sites were observed in the 60 mg/kg group.
*Pups data with dose level (with NOAEL value): Decrease in number of live pups at the day 0 and 4 of lactation were observed at 60 mg/kg group. Decrease in body weights of both sexes on the day 0 and 4 of lactation were noted in the 60 mg/kg group.
Dose level (mg/kg/day) 0 2.5 12.5 60
No. of pairs mated 13 13 13 13
No. of pregnant females12 13 13 12
Corpora lutea 16.4±1.8 17.0±0.7 16.5±4.6 14.0±2.4
Implantation scars 14.8±3.2 16.2±1.5 15.0±4.6 12.8±3.2
Pups born 13.8±3.0 15.5±1.6 13.8±4.3 10.5±3.1
Delivery index(% ) 93.5±6.2 95.2±4.2 92.4±7.4 83.3±17.9
Live pups born 13.8±3.0 15.3±1.6 13.5±4.4 10.3±2.9*
Live birth index (% ) 100±0.0 99.0±3.5 91.0±27.898.1±3.5
Live pups on day 4 of lactation
13.5±2.8 14.1±4.5 14.4±1.7 8.8±3.7*
Body weight of live pups (g)
on day 0
Males 7.0±0.7 6.6±0.4 6.8±0.8 5.8±1.2**
Females 6.7±0.6 6.8±1.4 6.3±0.7 5.6±1.3**
on day 4
Males 11.3±1.5 10.9±1.0 10.2±1.5 9.6±2.5*
Females 11.0±1.6 10.4±1.0 9.5±1.2 8.8±2.9**
(*P<0.05, **P<0.01)
Applicant's summary and conclusion
- Executive summary:
- method: 2 -tert-buty-5 -methylphenol was administered to SD(Crj:CD) rats by gavage at doses of 0 (vehicle ; corn oil) 2.5, 12.5 and 60 mg/kg from 14 days before mating to 14 days after mating in males and from 14 days before mating to day 3 of lactation in females. result: Maternal body weight gain and food consumption were suppressed in the 60 mg/kg group. No adverse effects were observed on copulation, fertility, delivery and lactation in any group. Slight effects to the maternal reproductive index, such as a slight decrease in the number of corpora lutea, implants, number of live neonates at birth and a slight low value of delivery index were observed at 60 mg/kg. In this dose group, the body weight gain of pups was suppressed. Evidence of malformations was not observed grossly at any dose group. based on the above results, the NOAEL for reproductive toxicity is considered to be 12.5 mg/kg for both female parents and pups reference: MHW, Japan (1999)
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