Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 268-329-4 | CAS number: 68052-51-7
- 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
Description of key information
Acute oral and dermal studies with TBEAES performed in accordance with current OECD/EC test guidelines and GLP principles, showed LD50 values >2000 mg/kg bw for acute oral and dermal toxicity in rats.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1999 - January 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crl:(WI) BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 7 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean (males 260 - 277 grams, females 172-188 grams).
- Fasting period before study: Food was witheld overnight (for maximum of 20 hours) prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Group housing of 3 animals per cage in labeled polycarbonate cages containing purified sawdust as bedding material.
- Diet: Free access to pelleted rodent diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
set to maintain:
- Temperature (°C): 21
- Humidity (%): 30 - 70
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12
Deviations from these optimal conditions were noted, but were considered not to have affected study integrity.
IN-LIFE DATES: From: 28 December 1999 tot 13 January 2000 - Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- GAVAGE METHOD: stainless steel stomach tubes.
Frequency: single dosage, on Day 1.
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg (10 mL/kg) body weight.
DOSAGE PREPARATION: The formulations (w/w) were prepared within 4 hours prior to dosing. The test substance was heated up to 70°C immediately prior to formulation. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of vehicle. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females and 3 males in a stepwise manner
- Control animals:
- no
- Details on study design:
- Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance. Water was available ad libitum.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Twice daily
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: At the end of the observation period. Descriptions of all internal macroscopic abnormalities were recorded
- Other examinations performed: none. - Statistics:
- No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured
- Clinical signs:
- other: In one female, uncoordinated movements were noted on day 1. No clinical signs were noted in the remaining two females. Among males, tremors and/or uncoordinated movements were noted on day 1.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study with rats, performed according to OECD/EC test guidelines, an LD50 >2000 mg/kg bw was determined.
- Executive summary:
Assessment of acute oral toxicity of TBEAES was performed in Wistar rats according to OECD/EC guidelines and GLP principles. TBEAES was administired in a single dose to rats of both sexes at 2000 mg/kg body weight. No mortality occured. In one female, uncoordinated movements were noted on day 1. No clinical signs were noted in the remaining two females. Among males, tremors and/or uncoordinated movements were noted on day 1. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. the oral LD50 value of TBEAES in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results TBEAES does not have to be classified and has no obligatory labelling requirements for oral toxicity according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The study has been performed according to OECD and/or EC guidelines and according to GLP principles (Klimisch 1).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August to October 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar strain, Crl:(WI) BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charkes River Deutschland, Sulzfeld, Germany.
- Age at study initiation: Young adult animals (approx. 8 weeks old)
- Weight at study initiation: Body weight variation was within +/- 20% of the sex mean (males 315-370 grams and females 202-233 grams).
- Housing: Individually housed in polycarbonate cages.
- Diet: Free access to pelleted rodent diet (Carfil Quality BVBA, Oud-Turnhout, Belgium).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
set to maintain:
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12
Deviations from these optimal conditions were noted, but were considered not to have affected study integrity.
IN-LIFE DATES: From 9 August 2000 to 23 August 2000 - Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- VEHICLE
- Justification for choice of vehicle: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor.
Dose volume: 10 mL/kg body weight.
DOSAGE PREPARATION
To facilitate preparation, the test substance and test substance formulation (w/w) were heated up to 70°C within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of vehicle. The temperature of the formulation at time of dosing was 30-40°C.
One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.
The formulation was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The formulation was held in contact with the skin with a dressing. A piece of Micropore tape was additionally used for fixation of the bandage in females only.
Frequency: Single dosage, on Day 1.
Washing: tap water. - Duration of exposure:
- 24 hours.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
Frequency of observations and weighing:
- Mortality/Viability: Twice daily
- Body weights: Days 1 (pre-administration), 8 and 15
- Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: At end of the observation period. Descriptions of all internal macroscopic abnormalities were recorded.
- Other examinations performed: none. - Statistics:
- None.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured
- Clinical signs:
- other: Chromodacryorrhoea was noted in two males and one female on days 1 and/or 2. Focal erythema was seen in the treated skin-aera of two males and two females during the observation period.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examinations of animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicity study with rats, performed according to OECD/EC test guidelines, an LD50 >2000 mg/kg bw was determined.
- Executive summary:
Assessment of acute dermal toxicity with TBEAES in the rat was performed according to OECD/ EC guidelines and according to GLP principles. TBEAES was administired to five Wistar rats of each sex by dermal application at 2000 mg/kg bw for 24 hours. No mortality occured. Chromodacryorrhoea was noted in two males and one female on days 1 and/or 2. Focal erythema was seen in the treated skin-area of two males and two females during the observation period. The changes noted in body weight gain in males and females were considered not indicative of toxicity. No abnormalities were found at macroscopic post mortem examination of the animals.The dermal LD50 value of TBEAES in Wistar rats was established to exceed 2000 mg/kg bw. Based on these results, TBEAES does not have to be classified and has no obligatory labelling requirement for dermal toxicity according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The study has been performed according to OECD and/or EC guidelines and according to GLP principles (Klimisch 1).
Additional information
Oral
Assessment of acute oral toxicity of TBEAES was performed in Wistar rats according to OECD/EC guidelines and GLP principles. TBEAES was administered in a single dose to rats of both sexes at 2000 mg/kg body weight. No mortality occurred. In one female, uncoordinated movements were noted on day 1. No clinical signs were noted in the remaining two females. Among males, tremors and/or uncoordinated movements were noted on day 1. The body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of TBEAES in Wistar rats was established to exceed 2000 mg/kg body weight.
Dermal
Assessment of acute dermal toxicity with TBEAES in the rat was performed according to OECD/ EC guidelines and according to GLP principles. TBEAES was administered to five Wistar rats of each sex by dermal application at 2000 mg/kg bw for 24 hours. No mortality occurred. Chromodacryorrhoea was noted in two males and one female on days 1 and/or 2. Focal erythema was seen in the treated skin-area of two males and two females during the observation period. The changes noted in body weight gain in males and females were considered not indicative of toxicity. No abnormalities were found at macroscopic post mortem examination of the animals.The dermal LD50 value of TBEAES in Wistar rats was established to exceed 2000 mg/kg bw.
Justification for classification or non-classification
Based on the available studies, TBEAES does not have to be classified for acute toxicity according to CLP Regulation EC (No.) 1272/2008.
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.