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EC number: 217-752-2 | CAS number: 1948-33-0
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from a publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the Teratogenic Potential of Tertiary Butylhydroquinone (TBHQ) in the Rat
- Author:
- Walter J. Krasavage
- Year:
- 1 977
- Bibliographic source:
- TERATOLOGY Volume 16, Issue 1, pages 31–33, August 1977.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- The experimental diets containing 0, 0.125, 0.25 or 0.50% test chemical were fed from day 6 to day 16 of gestation to Sprague-Dawley rats. On day 20 of gestation, the teratologic effects were examined.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-tert-butylhydroquinone
- EC Number:
- 217-752-2
- EC Name:
- 2-tert-butylhydroquinone
- Cas Number:
- 1948-33-0
- Molecular formula:
- C10-H14-O2
- IUPAC Name:
- 2-tert-butylbenzene-1,4-diol
- Details on test material:
- - Name of test material (as cited in study report):2-tert-butylhydroquinone (TBHQ)
- Molecular formula (if other than submission substance):C10H14O2
- Molecular weight (if other than submission substance):166.22 g/mol
- Substance type:Organic
- Physical state:solid
Constituent 1
- Specific details on test material used for the study:
- - Molecular weight (if other than submission substance):166.22 g/mol
- Substance type:Organic
- Physical state:solid
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Sexually mature Sprague-Dawley rats were used
- Diet (e.g. ad libitum): PURINA Laboratory Chow supplemented with 5.0% Mazola brand corn oil, ad libitum
- Water (e.g. ad libitum): Ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: PURINA Laboratory Chow supple-mented with 5.0% Mazola brand corn oil
- Details on exposure:
- DIET PREPARATION
- Mixing appropriate amounts with (Type of food): Test chemical was added to ground PURINA Laboratory Chow supplemented with 5.0% Mazola brand corn oil in concentrations of 0, 0.125, 0.25 or 0.5% - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No Data Available
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1:2
- Proof of pregnancy: Inseminations were verified by daily vaginal smears
- After successful mating each pregnant female was housed individually - Duration of treatment / exposure:
- Day 6 to 16 of gestation period
- Frequency of treatment:
- daily
- Duration of test:
- Upto day 20 of gestation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, About 125, 250 or 500 mg/kg
Basis:
nominal in diet
0, 0.125, 0.25 or 0.50%
- No. of animals per sex per dose:
- Control: 20 females
125 mg/kg: 20 females
250 mg/kg: 20 females
500 mg/kg: 20 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The selected doses were 62.5, 125 and 250 times the approved use level for humans
- Rationale for animal assignment: Inseminated females were randomly assigned to one of four groups (20 rats/group)
Examinations
- Maternal examinations:
- Individual body weights were recorded on the day of insemination and daily throughout the period of gestation. Food consumption was monitored from day 0 to 20 of gestation. The mean body weight of the fetuses was calculated by averaging the body weight per litter within each group and calculating the mean of these values to obtain the group mean.
- Ovaries and uterine content:
- On day 20 of gestation, the females were killed by ether inhalation and the uteri were exposed by laparotomy. Total implantation sites were counted and categorized as consisting of live fetuses, dead fetuses or resorptions.
The ovaries of all females were removed and the total number of corpora lutea was recorded - Fetal examinations:
- The fetuses were removed from the placentae, blotted dry, carefully examined for gross anomalies, sexed and weighed. Half of the fetuses were fixed in Bouin's fixative and examined for internal soft tissue anomalies according to the free-hand razor blade technique. The other half were fixed in 95% ethanol, eviscerated, macerated in KOH and stained with alizarin red for skeletal examination.
- Statistics:
- No Data Available
- Historical control data:
- No Data Available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- 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:
- not specified
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- No Data Available
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- not specified
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No effect on the mean body weight gain or food consumption of the dams
Average number of corpora lutea, implantation sites, viable fetuses, resorptions and body weight of the fetuses per litter, fetal mortality and sex ratio were unaffected at 125, 250 or 500 mg/kg levels of treatment.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- dead fetuses
- early or late resorptions
- food consumption and compound intake
- gross pathology
- histopathology: non-neoplastic
- maternal abnormalities
- number of abortions
- pre and post implantation loss
- total litter losses by resorption
- Remarks on result:
- other: teratogenicity was measured
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Some sporadic cases were observed wherein the animals in 500 mg/kg were found to be of lesser weight whn compared to control.
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
A significant number of rudimentary ribs were seen in all groups. However, the incidence of this variation was two times greater in the control group than in any treatment group (125, 250 or 500 mg/kg)
The ingestion of test chemical did not cause any gross external or internal tissue anomalies.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL value for the test chemical to Sprague-Dawley rats was determined to be about 500 mg/kg bw in diet. The substance did not produce any teratogenic effects at this dose level.
- Executive summary:
The test chemical is an approved antioxidant used alone or in combination with other antioxidants in food. The teratogenic potential of test chemical is examined in this study. Test chemical was administered via the diet to pregnant Sprague-Dawley rats at concentrations of 0,0.125, 0.25or0.50% (about 0,125, 250 or 500 mg/kg bw) during the sensitive period of gestation. The experimental diets were fed from day 6 to day 16 of gestation. On day 20 of gestation, the females were killed by ether inhalation and examined for teratologic effects. The results of the present study revealled, the mean body weight and feed consumption of the dams were unaffected. The average number of corpora lutea, implantation sites, viable fetuses, resorptions and fetal body weights and mortality did not differ between the control and treated groups. Skeletal examinations revealed a significant number of fetuses with rudimentary ribs; however, the control group showed twice as many animals with this anomaly. Test chemical also did not result in any gross external or internal tissue anomalies in the fetuses. Therefore, it is concluded that test chemical fed to pregnant rats at doses up to 250 times the approved use level for humans caused no abnormalities in rat fetuses. The substance was considered to be non-teratogenic at all dose levels and the NOAEL is determined to be about 500 mg/kg bw in diet.
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