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EC number: 217-886-1 | CAS number: 1999-85-5
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Study period:
- 04 August 2011 - 17 April 2012
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The study has many deviations and the information in the report is incomplete.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Principles of method if other than guideline:
- The study has many deviations and the information in the report is incomplete.
- evaluation of oestrus cycle and sperm parameters.
- organ weights
- chemical analysis of concentrations in feed (plus validation)
- Only summary tables provided. Tables with individual data should be included.
- (individual) tables on clinical observations
- No macroscopic post-mortem evaluations reported and no full histopathology report on observations per animal. Only acute testicular necrosis and 4 pelvic dilatations in P male of 2500ppm group is mentioned.
- No information reported on pup observations (anomalies), neuro-behavioural evaluations, and specifically sexual maturation (vaginal opening or balano-preputial separation)
- No specific litter and pup information reported (pups/dam, sex ratio). Table on pup survival table 16 and 18 are unclear as to how many pups died when.
- Information on implantation sites in uterus missing. Therefore information on post-implantation loss is missing.
- The laboratory has no GLP accreditation - GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
- EC Number:
- 217-886-1
- EC Name:
- α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
- Cas Number:
- 1999-85-5
- Molecular formula:
- C12H18O2
- IUPAC Name:
- 2-[3-(2-hydroxypropan-2-yl)phenyl]propan-2-ol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name: α,α,α',α'-tetramethyl-m-xylene-α,α'-diol
Lot No.: 101155
odourless white solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- corn oil
- Remarks:
- Test substance was milled by a mortar and sieved by 100 mesh for the test.
- Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: until proof of mating or up to 2 weeks
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy
- After ?? days of unsuccessful pairing replacement of first male by another male with proven fertility.
- Further matings after two unsuccessful attempts: no data
- After successful mating each pregnant female was caged (how): no data
- Any other deviations from standard protocol: see above - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- males: mating period
females: mating period, up to and including lactation - Frequency of treatment:
- daily via the diet
- Details on study schedule:
- F1: Four male and four female pups were randomly selected as representatives of each litter. After weaning, the breeding programme was repeated with the F1 parents to reduce the F2A litters after a 10 week pre-mating period.
F2: The pups were humanely killed and examined in 3 weeks age.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0,150, 600, 2500, 10000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- P0: 30
F1: 4 from each litter - Control animals:
- yes
Results and discussion
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Abstract from study report:
Results
There were reductions in bodyweight during pre-mating period in F0 and F1 animals receiving 10000 ppm combined by reduced bodyweight in F1 and F2 pups. There were no effects of α,α,α',α'-tetramethyl -m-xylene-α,α'-diol on reproductive parameters and dose levels up to and including 10000 ppm.
Conclusions
There were no effects of α,α,α',α'-tetramethyl-m-xylene-α,α'-diol on reproductive parameters at dose levels up to 10000 ppm.
There were signs of toxicity in parents and offspring receiving 10000 ppmα,α,α',α'-tetramethyl-m-xylene-α,α'-diol, seen as reduced bodyweight.
The NOAEL was 2500 mg/kg diet, equivalent to 168.0 mg/kg bw/d for males, 253.9 mg/kg bw/d for females.
Applicant's summary and conclusion
- Conclusions:
- There were no effects of α,α,α',α'-tetramethyl-m-xylene-α,α'-diol on reproductive parameters at dose levels up to 10000 ppm.
There were signs of toxicity in parents and offspring receiving 10000 ppmα,α,α',α'-tetramethyl-m-xylene-α,α'-diol, seen as reduced bodyweight.
The NOAEL was 2500 mg/kg diet, equivalent to 168.0 mg/kg bw/d for males, 253.9 mg/kg bw/d for females. - Executive summary:
Abstract from study report:
Study design
Groups of 30 male and female (F0 parents) Wistar rats were fed diet containing 0(control), 150, 600, 2500 or 10000 ppmα,α,α',α'-tetramethyl -m-xylene-α,α'-diol.After 10 weeks, the animals were mated and allowed to rear the F1A litters to weaning. The breeding programme was repeated with the F1 parents selected from the F1A offspring to produce the F2A litters after a 10 week pre-mating period. Test diets were fed continuously throughout the study.
Results
There were reductions in bodyweight during pre-mating period in F0 and F1 animals receiving 10000 ppm combined by reduced bodyweight in F1 and F2 pups. There were no effects of α,α,α',α'-tetramethyl -m-xylene-α,α'-diol on reproductive parameters and dose levels up to and including 10000 ppm.
Conclusions
There were no effects of α,α,α',α'-tetramethyl-m-xylene-α,α'-diol on reproductive parameters at dose levels up to 10000 ppm.
There were signs of toxicity in parents and offspring receiving 10000 ppmα,α,α',α'-tetramethyl-m-xylene-α,α'-diol, seen as reduced bodyweight.
The NOAEL was 2500 mg/kg diet, equivalent to 168.0 mg/kg bw/d for males, 253.9 mg/kg bw/d for females.
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