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EC number: 251-073-2 | CAS number: 32509-66-3
- 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 generations indicated in Effect levels (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug - Dec 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well performed and reported non-guideline study with scientific sound design and sufficient reporting.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rats were fed diets containing the test item at different levels and mated. The litters were reared and observations were made on fertility of females, number of young born per litter, sex ratio, grossly visible abnormalities, mortality, body weights and resorption percentage.
- GLP compliance:
- no
- Remarks:
- performed before GLP guidelines
- Limit test:
- no
Test material
- Reference substance name:
- DTB-glycolester
- IUPAC Name:
- DTB-glycolester
- Reference substance name:
- Bis-(3,3-di(4-oxy-3 tert. butyl-phenyl)butane acid)-glycolester
- IUPAC Name:
- Bis-(3,3-di(4-oxy-3 tert. butyl-phenyl)butane acid)-glycolester
- Reference substance name:
- Hostanox O 3
- IUPAC Name:
- Hostanox O 3
- Test material form:
- solid: crystalline
- Details on test material:
- white crystalline material
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands
- Age at study initiation: 11 weeks
- Weight at study initiation: (P) Males: 268 g; Females: 179 g
- Housing: in groups of five in screen-bottomed, stainless steel cages
- Diet (e.g. ad libitum): CIVO basal diet (containing 29.7% yellow maize, 36% whole wheat, 11% defatted soy-bean mael, 4% meat scraps, 7% fish meal, dried whey, brewer's yeat, grass meal, soy-bean oil, vitamin preparations, trace mineralized salt, steamed bone meal), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 2 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-25°C
- Humidity (%): 50%
- lighting 12 h daily
3 weeks acclimatisation
IN-LIFE DATES: From: Aug. 1978 To: May 1981 (end of subsequent chronic toxicity study)
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: CIVO basal diet
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency):
The test diets were normally prepared in batches once every 3 to 4 weeks.
The test material was thoroughly mixed into CIVO basal diet by means of a mechanical blender at levels of 0 (control), 0.16, 0.4 or 1.0%. The diets were stored in an unheated room at ambient temperatur - Details on mating procedure:
- After the pre-mating period (30 days) the rats were mated within their diet group. Each male was housed with two females in a cage for one week. At week 2 and 3 of the mating period each male rat was transferred to another "mating" cage within the same diet group. So, three different males were available for each dam. After a mating period of three weeks, the females were caged individually, until their litters had been weaned.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- Males: 7 weeks (4 weeks pre-mating, 3 weeks mating)
Females: 13 weeks (4 weeks pre-mating, 3 weeks mating, 3 weeks gestation, 3 weeks lactation) - Frequency of treatment:
- continuously
- Details on study schedule:
- - Age at mating of the mated animals in the study: 15 weeks
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.16%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0.4%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
1.0%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15 males/dose
30 females/dose - Control animals:
- yes, plain diet
- Details on study design:
- no data
- Positive control:
- No
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
In the pre-mating period of 30 days food intake was recorded at weekly interval. - Oestrous cyclicity (parental animals):
- no data
- Sperm parameters (parental animals):
- no data
- Litter observations:
- Records were made of the number of pups in each litter, sex ratio at birth and the weight of the litter at day 1,4, 14 and 21 of lactation. Litters containing more than 8 siblings were randomly reduced to 8 on day 1 of lactation, in order to equalize the stress of lactation among the dams.
- Postmortem examinations (parental animals):
- After weaning their young, the mothers were sacrificed and the implantation sites in the uterus were counted after staining with ammonium sulfide solution. The males were discarded.
- Postmortem examinations (offspring):
- n.a., since the offspring was used a subsequent combined chronic toxcity/carcinogenicity study (please refer to study report no. R 6693; IUCLID Chapter 7.5.1; WoE_130 week oral toxicity (diet)_rat_TNO_1982)
- Statistics:
- All data were evaluated by means of the Student t-test.
- Reproductive indices:
- - female fertility index = (number of pregnant females/number of females placed with males) x 100
- gestation index = (number of females with live pups/number of females pregnant) x 100
- post-implantation loss = [(number of implantation sites - number of pups born alive)/number of implantation sites] x 100 - Offspring viability indices:
- - Sex ratio at birth = no. of males alive/no. of females alive
- Viability Index at day 1 = (No. of pups born alive/total no. of pups born) x 100
- Viability Index at day 4 = (No. of pups alive days 4/total no. of pups alive day 1) x 100
- Lactation Index = (No. of pups alive day 21/no. of pups alive on dy 4) x 100
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- slightly reduced in males at mid- and high dose
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- slightly reduced in males at mid- and high dose
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Test substance intake: slightly reduced in males at mid- and high dose
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
Details on results (P0)
No abnormalities of condition or behaviour were observed in any of the groups during the pre-mating, mating or lactation period. At 0.4 and 1% dose level body weights were relatively low in males, while in females the figures of the various groups were very similar. Food intake tended to be decreased in all test groups, but the differencs with the control group were very small.
- Fertility:
All females of the control group and of the 0.16 and 0.4% dose group casted a litter while in the 1.0% dose group only 1 out of 30 females was not fertile. The mean litter size at birth showed some variation amongst the groups, but there were no indications of an adverse effect of the test substance. The resorption quotient of the various groups did not reveal any embryo-toxic properties of the test substance. None of the other parameters examined was affected by the feeding of the test item.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 other: % in diet
- Sex:
- male/female
- Basis for effect level:
- other: only slightly reduced body weight in males of high dose group observed
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced in high dose group
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 other: % in diet
- Sex:
- male/female
- Basis for effect level:
- other: reduced body weight in high dose group
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- HostanoxO 3 was studied for its reprodcutive toxic/teratogenic properties in a one-generation combined chronic toxicity study in male and female Wistar rats. The NOAEL was considered to be 1% (corresponding to 500 mg/kg bw/d; highest dose tested) in diet. None of the fertility/viability parameters examined was adversely affected by the feeding of the test substance. Slightly reduced body weight was observed in males and pups of the high dose group.
- Executive summary:
The feeding of DTB-glycolester at dietary levels of 0, 0.16, 0.4 or 1% (corresponding to 0, 70, 200 and 500 mg/kg bw/d considering a diet conversion factor (ppm to mg/kg bw/d) of 20) to rats resulted in slight growth depression and relatively low food intake in male parent rats of the mid and high dose group. The only change observed in the litters consisted of slight growth retardation of the pups in the top dose group during the final stage of the lactation period. The other data on fertility, lactation performance and survival did not reveal any abnormalities.
From the present reproduction study it is therefore concluded that the feeding of the test substance at dietary levels up to 1.0% failed to induce any deleterious effects, other than slight growth depression in parent males at 0.4 and 1.0% and in pups at 1.0%.
The F1 -generation was used for a subsequent chronic toxicity study (130 weeks duration, please refer to IUCLID Chapter 7.5.1). No visceral malformations could be found at the termination of this chronic study and therefore, no teratogenic effects were recorded. Furthermore, the rate of mortality was not affected, the body weight differences of rats of the dose groups with the control animals were smaller than 10% and there were no outstanding differences in food intake observed during the chronic toxicity study performed in the F1 -generation.
The NOAEL was considered to be 1% (corresponding to 500 mg/kg bw/d; highest dose tested) in diet. None of the fertility/viability parameters examined was adversely affected by the feeding of the test substance. Slightly reduced body weight was observed in males and pups of the high dose group.
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