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EC number: 605-029-8 | CAS number: 155852-41-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 05 February 2002 to 08 March 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study without detailed documentations. Clinical observations were limited to 1, 3, 5, 24 and 48 hours after administration of the test material.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- dated February 24th, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- dated December 29th, 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- ADHBFA-Me
- IUPAC Name:
- ADHBFA-Me
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA CREDO (69210 L'Arbresle - France)
- Age at study initiation: no data
- Weight at study initiation: 166-189 g for males and 150-168 g for females
- Fasting period before study: no data
- Housing: no data
- Diet: Certified A04 Rats/Mice Maintenance Diet (document from supplier attached to the Study Report without further details)
- Water: no data
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-33
- Humidity (%): 33-49
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: no data
MAXIMUM DOSE VOLUME APPLIED: 1.7 ml/kg body weight - Doses:
- 2000 mg/ kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations: 1 hour, 3, 5, 24 and 48 hours after administration of the test material.
- Clinical observations: spontaneous activity, preyer's reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, turning reflex, back hair appearance
- Frequency of weighing: the day of administration of the test material (Day 0), and then at Days 2, 7 and 14.
- Necropsy of survivors performed: yes/ Observed organs: Oesophagus, Stomach, Duodenum, Jejunum, Ileon, Caecum, Colon, Rectum, Spleen, Liver, Thysmus, Trachea, Lungs, Heart, Kidneys, Urinary bladder, testis, ovaries, uterus, Adrenals and Pancreas
- Other examinations performed: clinical signs, body weight. - Statistics:
- Not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality and no clinical signs
- Mortality:
- No mortality occured during the study.
- Clinical signs:
- other: 3 hours after the administration of the test material, there was a decrease in the spontaneous activity in all the treated rats. Afterwards, rats recovered a normal activity, and 24 hours after the administration of the test material, no treatment related
- Gross pathology:
- The macroscopical examination of the animals at the end of the study did not reveal any treatment-related change.
- Other findings:
- No further findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, the oral LD50 of the test material is higher than 2000 mg/kg body weight without mortality or clinical signs. Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Dangerous Substances Directive 67/548/EEC (DSD) criteria.
- Executive summary:
This GLP-compliant study was performed to assess the acute oral toxicity of the test material, according to OECD Guideline 401 (dated February 24th, 1987) and EU method B.1 of the E.E.C. directive n° 92/69 (dated December 29th, 1992).
Material and methods
The test material -diluted in distilled water- was administered by gavage to a group of 10 Sprague Dawley rats (5 males and 5 females) at a single dose of 2000 mg/kg body weight. A concurrent control group was treated in the same conditions with the vehicle alone.
Animals were monitored 1 hour, 3, 5, 24 and 48 hours after administration of the test material, and were weighed on days D0, D 2, 7 and 14.
Results
No mortality occurred during the study.
Three hours after the administration of the test material, there was a decrease in the spontaneous activity in all the treated rats. Then, rats recovered a normal activity, and 24 hours after the administration of the test material, no treatment related clinical signs were observed.
The body weight evolution of rats showed a decrease of the weight gain at Day 2 in the group of treated rats as compared to the control group (- 47% to male rats and - 86% to female's rats). Then, the weight evolution remained normal and at the end of the study, the weight was similar between treated and control animals.
The macroscopical examination of the animals at the end of the study did not reveal any treatment-related change.
Conclusion
Under the experimental conditions of this study, the oral LD50 of the test material is higher than 2000 mg/kg body weight without mortality or clinical signs. Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Dangerous Substances Directive 67/548/EEC (DSD) criteria.
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