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EC number: 212-090-0 | CAS number: 761-65-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
According to REGULATION (EC) No. 1907/2006 (REACH), Annex VIII, section 8.7.1, column 2, a screening for reproductive/developmental toxicity can be omitted, as a prenatal developmental toxicity study (Annex IX, section 8.7.2) is available and relevant human exposure can be excluded in accordance with Annex XI, section 3; based on the exposure scenario(s) developed in the Chemical Safety Report.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because a pre-natal developmental toxicity study is available
- the study does not need to be conducted because relevant human exposure can be excluded as demonstrated in the relevant exposure assessment
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
According to REACH Annex VIII, section 8.7.1, column 2, a screening for reproductive/developmental toxicity can be omitted, as a prenatal developmental toxicity study (Annex IX, section 8.7.2) is available and relevant human exposure can be excluded in accordance with Annex XI, section 3:
Exposure based adaptation of information requirements:
Testing in accordance with sections 8.6 (repeated dose toxicity) and 8.7 (reproductive toxicity) of REACH Annex VIII may be omitted if relevant human exposure can be excluded in accordance with REACH Annex XI section 3. In accordance with section 3.2 (b) of Annex XI, testing can be omitted where the substance is not incorporated in an article and the manufacturer/importer can demonstrate and document for all relevant scenarios that throughout the life cycle strictly controlled as well as rigorously contained conditions as set out in Article 18(4)(a) to (f) (Regulation 1907/2006) apply.
The substance DBF is manufactured and used under strictly controlled conditions over the entire lifecycle. Possible exposure is limited to sampling and cleaning and maintenance work under strictly controlled conditions with limited exposure probability: Only a small, well-defined and trained group of workers is involved in these processes and the possible exposure occasionally to low levels of DBF is considered controlled using appropriate risk management measures to minimize exposure.
Therefore, on the basis of the described process conditions, testing of DBF for repeated dose toxicity and/or toxicity to reproduction should not be performed since the criteria of exposure-based adaptation of information requirements according to Annex XI section 3.2 (b) are clearly met.
An adequate justification and documentation for this adaptation is attached in the respective field in IUCLID section 7.8.1: "Attached justification". The relevant exposure scenarios are provided in the CSR, attached in IUCLID section 13.1.
Effects on developmental toxicity
Description of key information
Prenatal developmental toxicity, rabbits:
The NOAEL for maternal toxicity was determined to be 125 mg/kg bw/day, the NOAEL for prenatal developmental toxicity including teratogenicity was determined to be 250 mg/kg bw/day.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983-04-25 to 1983-10-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 82/330
- Purity test date: 1982-10-26 - Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr . K . THOMAE GmbH, Biberach, Germany
- Age at study initiation: 27-69 weeks
- Weight at study initiation: Mean body weight of the animals: 2.55 kg
- Housing: Singly housing in stainless steel cages (area: 2860 cm2).
- Diet: standardized animal laboratory diet (about 130 g/animal/day)
- Water: tap water (about 500 mL/animal/day).
ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes: air-conditioned rooms
- Photoperiod: 12 h light and 12 h darkness - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test substance was emulgated in CMC (basis: weight/volume). During the period of treatment the suspensions were prepared daily, shortly before the beginning of treatment.
The concentration of the suspensions was 3.1% for the 62 mg/kg bw/day dose, 6.25% for the 125 mg/kg bw/day dose and 12.5% for the 250 mg/kg bw/day dose. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration of the emulsion was tested twice.
- Details on mating procedure:
- - Impregnation procedure: artificial insemination
One hour prior to insemination 40 I.U. of Primogonyl R (= chorionic gonadotropin, trade product of SCHERING AG, Berlin/Bergkamen, FRG, dissolved in 1 mL of physiological saline solution) were injected intravenously (ear vein) into each animal. The day of insemination was designated day 0 of pregnancy, the following day the first day post insemination (p.i.). - Duration of treatment / exposure:
- 13 successive days (from the 6th -18th day post insemination)
- Frequency of treatment:
- daily at the same time of day (in the morning). The amount of test substance to be administered at each dose level per kg body weight was contained in a volume of 2 mL.
- Duration of test:
- from the 6th -18th day post insemination
- Dose / conc.:
- 62 mg/kg bw/day
- Dose / conc.:
- 125 mg/kg bw/day
- Dose / conc.:
- 250 mg/kg bw/day
- No. of animals per sex per dose:
- 62 mg/kg bw/day; 22
125 mg/kg bw/day: 14
250 mg/kg bw/day: 22 - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: In a preliminary study (doses: 31, 62, 125 and 250 mg/kg bw/day), rabbits were orally administered from day 6 - 18 p.i. Only at a dose of 250 mg/kg bw/day a slight till questionable embryolethality was demonstrated. Thus, 250 mg/kg was selected as the high dose for the main study. Supportingly, the acute oral LD50 in rats is about 1050 mg/kg bw/d (BASF SE, 1979), and mortality of pregnant rats is described after single dermal appllication of 1200 mg/kg DBF at GD10 (Stula et al., 1977). Therefore, the MTD after repeated exposure for rats is expected to be well below 500 mg/kg.
- Details on control animals: A further group of animals was treated with a 0.5% aqueous CMC formulation and treated and investigated in the same way - Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Three times in the week
FOOD CONSUMPTION AND COMPOUND INTAKE : Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Organs examined: Ovaries and uterine
Animals were sacrificed by rapid intravenous administration (ear vein) of 1 mL/kg + 1 mL Nembutal R (= pentobarbital sodium, 60 mg/mL, trade product of ABBOTT GmbH). - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes, on day 29
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
The length and weight of the fetuses as well as the weight of the placentas were determined.
All fetuses were eviscerated, their sex was determined, and the organs were examined macroscopically. Subsequently the fetuses were X-rayed for the evaluation of the skeletons. After being X-rayed, the heads were fixed in BOUIN's solution, and after fixation they were processed and evaluated according to the method of WILSON. - Statistics:
- method of WILSON
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 62 and 125 mg/kg bw /day: non-treatment related diarrhoe and conjunctivitis
The dose of 250 mg/kg bw/day showed symptoms, which were related to the test substance administration. Following symptoms were oberseved: Mydriasis, tachycardia, uncertain gait, apathy. - Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- From days 5 to 6 post insemination a significant increase in food consumption was observed for the highest dose group compared to the control group.
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- no significant differences in weight of uteri
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- control: one animal with changes in liver morphology, 4 animals with cysts in uterine horns
62 mg/kg bw/day: 5 animals with cysts in uterine horns
125 mg/kg bw/day: 2 animals with cysts in uterine horns
250 mg/kg bw/day: 4 animals with cysts in uterine horns - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Other effects:
- no effects observed
- Description (incidence and severity):
- No changes in numbers of corpora lutea, dead or alive implants, preimplantative lost of eggs was observed. The conception rate was between 77.78 and 92.86 %.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Abnormalities:
- not examined
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - 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:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: prenatal developmental toxicity including teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rabbit
- Quality of whole database:
- GLP compliant guideline study with acceptable restrictions
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no adverse effect observed
- Species:
- rat
- Quality of whole database:
- peer reviewed literature
Additional information
In the OECD 414 guideline prenatal developmental toxicity study, the test substance was administrated daily orally to Himalayan rabbits over an exposure time of 13 days from day 6 through day 18 post insemination. Doses of 62, 125, 250 mg/kg bw/day were used. Maternal toxic effects were not recorded in animals at 62 and 125 mg/kg bw/day. At 250 mg/kg bw/day slight maternal toxicity occurred in the form of substance-related adverse clinical findings. However, substance-related embryo- or fetotoxicity was not seen at all three dose levels. The NOAEL for maternal toxicity was determined to be 125 mg/kg bw/day; the NOAEL for prenatal developmental toxicity including teratogenicity was determined to be 250 mg/kg bw/day, the highest dose level investigated (1984, reliability score: 2).
Supportingly, after DBF exposure once or twice on the skin of pregnant rats during the period of fetal organogenesis, no teratogenic effects were detected. In this study, secondary embryo-mortality was found at the dose level 1200 mg/kg bw, where mortality of the dams occured (Stula and Krauss, 1977).
Mode of Action Analysis / Human Relevance Framework
No data available.
Justification for classification or non-classification
Due to the exposure based adaptation of information requirements, no data on fertility effects are available for DBF. Thus, no classification is warranted acccording to REACH Regulation (EC) No 1907/2006.
For developmental toxicity, the available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for developmental toxicity, as amended for the tenth time in Regulation (EU) No 2017/776.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.