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EC number: 419-240-6 | CAS number: 171054-89-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.04.1995 - 15.05.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 419-240-6
- EC Name:
- -
- Cas Number:
- 171054-89-0
- Molecular formula:
- Hill formula: C28H37NO7 CAS formula: (C11H12O3)2.C6H13NO
- IUPAC Name:
- bis(4-(4-methylphenyl)-4-oxobutanoic acid); 4-ethylmorpholine
- Test material form:
- solid: crystalline
- Details on test material:
- Sponsor's identification: TKA 40074 (CGCI 1405)
cream coloured
2:1 adduct of Benzenebutanoic acid, 4-methyl-gamma-oxo and 4-ethylmorpholine
batch No.: 1/94
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male and female Sprague-Dawley CD strain rats supplied by Charles River (UK) Ltd., Margate, Kent, UK were used. At the start of the main study the males weighed 140 to 150 g, and the females 128 to 136 g, and were five to eight weeks of age. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card.
The animals were housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
The animal room was maintained at a temperature of 19 to 23 °C and relative humidity of 45 to 55%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- For the purpose of the study the test material was freshly prepared, as required, as a suspension at the appropriate concentration in arachis oil B. P.. Determination by analysis of the concentration, homogeneity and stability of the test material preparations was not appropriate because it was not specified in the Study Plan and is not a requirement of the Test Guideline.
All animals were dosed once only by gavage using a metal cnnula attached to a graduate syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing. - Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days.
Individual bodyweights were recorded prior to dosing on Day 0 and on Day 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Results and discussion
- Preliminary study:
- A range-finding study was performed to establish a dosing regime as follows:
Dose level: 2000 mg/kg bw; concentration: 200 mg/ml; 1 male and 1 female rat
The animals were observed for deaths or overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 5 days.
Individual bodyweights were recorded on the day of dosing to allow calculation of individual treatment volumes. No necropsies were performed.
There were no deaths. Clinical signs of toxicity noted were hunched posture, lethargy, decreased respiratory rate and laboured and noisy respiration up to three days after dosing.
Based on this information, a dose level of 2000 mg/kg bodyweight was selected for the main study.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels:
No death occured. Hunched posture, lethargy and decreased respiratory rate were observed up to two days after dosing. - Body weight:
- 3-0 Male: Day 0 (141 g); Day 7 (196 g); Day 14 (239 g)
3-1 Male: Day 0 (148 g); Day 7 (212 g); Day 14 (271 g)
3-2 Male: Day 0 (150 g); Day 7 (228 g); Day 14 (285 g)
3-3 Male: Day 0 (145 g); Day 7 (206 g); Day 14 (264 g)
3-4 Male: Day 0 (140 g); Day 7 (199 g); Day 14 (254 g)
4-0 Female: Day 0 (128 g); Day 7 (170 g); Day 14 (190 g)
4-1 Female: Day 0 (136 g); Day 7 (189 g); Day 14 (216 g)
4-2 Female: Day 0 (135 g); Day 7 (196 g); Day 14 (230 g)
4-3 Female: Day 0 (130 g); Day 7 (178 g); Day 14 (196 g)
4-4 Female: Day 0 (128 g); Day 7 (178 g); Day 14 (191 g) - Gross pathology:
- Effects on organs:
No treatment-related macroscopic findings were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method followed that in the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" (adopted 24 February 1987) and Method B1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.
Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material as a suspension in arachis oil B.P. at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.
There were no deaths. Hunched posture, lethargy and decreased respiratory rate were noted during the study.
All animals showed an expected increase in bodyweight during the study.
No abnormalities were noted at necropsy.
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