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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-075-4 | CAS number: 78-00-2
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
The LD50 values for this material have been repeatedly tested orally, dermally and by inhalation. All study groups show simliar values for each exposure type, therefore there is much supporting evidence to back up the key value studies used to classify the substance as very toxic even though in many cases full details of test methods are not available
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. Reliability assessment as per that quoted in IUCLID 4 (2000) data review
- Principles of method if other than guideline:
- 16 animals assigned to 4 groups were dosed via intragastric intubation with with different levels of TEL dissolved in peanut oil. Mortality data was collected over a period of 14 days and the LC50 value determined by producing a response curve
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 8 males (350 - 425 grams in weight) and 8 female (150 - 250 grams in weight)
Temperature and light controlled confined room with 12 hour light cycles with no contact to sunlight or UV light - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- TEL at 7.32 mg/ml of pure peanut oil
2 ml of oil administered per animal
Single dose then observation for 14 days to collect mortality data - Doses:
- 4 groups dosed at 10/13/16.9/21.97 mg TEL/kg bw
- No. of animals per sex per dose:
- Equal number of males and females per group
- Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 14.18 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 12.62 - < 15.93
- Mortality:
- Mortalities after 14 days observed were:
1 of 4 @ 10 mg/kg
0 of 4 @ 13 mg/kg
4 of 4 @ 16.9 mg/kg
4 of 4 @ 21.97 mg/kg - Interpretation of results:
- very toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- An LD50 value of 14.18 mg/kg is reported in rats
- Executive summary:
Schroeder (1972) showed the oral LD50 of TEL to be 14.18mg/kg bw. The research was based on a sample group of 16 rats in four groups or four with each group receiving a different dose level of TEL. All animals displayed neurological signs including lethargy, irritability, ataxia, violent trembling and aggressiveness. In animals dosed at the higher two dose levels death followed from day 6 and all 8 animals died by the end of the study on day 14. The LD100 was 16.9mg/kg bw
Reference
All animals displayed neurological signs including lethargy, irritability and ataxia from day 2. Violent trembling and aggressiveness then followed from day 5 with convulsions and death from day 6. These signs appeared sooner in those animals receiving the higher doses
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 14.18 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. Reliability assessment as per that quoted in IUCLID 4 (2000) data review
- Principles of method if other than guideline:
- Inhalation exposures were carried out in a glass chamber. Groups of 4 rats were exposed to TEL vapour with only their heads in contact with the vapour. Pure solutions of TEL were injected into the chamber with the air flow maintained at 50 litres per minute. Samples of air were taken at intervals during the 60 minute exposure period and analysed for TEL content. Lethal doses and their 95% confidence limits were calculated by reported method
- GLP compliance:
- no
- Remarks:
- Test completed before GLP implemented
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- 175-230 g in weight
- Route of administration:
- inhalation
- Type of inhalation exposure:
- head only
- Vehicle:
- air
- Details on inhalation exposure:
- Pure TEL in 50 l / min air flow
7 sample groups of 12 -20 rats with each group receiving a different dose level of TEL - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Polargraphical measurement of TEL content after conversion to lead chloride
- Duration of exposure:
- 60 min
- Concentrations:
- 0.095 mg/l, 0.19 mg/l, 0.37 mg/l, 0.77 mg/l, 1.58 mg/l, 2.77 mg/l and 4.84 mg/l
- No. of animals per sex per dose:
- 0.095 mg/l: 16
0.19 mg/l: 16
0.37 mg/l: 20
0.77 mg/l: 16
1.58 mg/l: 16
2.77 mg/l: 20
4.84 mg/l: 12 - Control animals:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- ca. 0.85 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Dose descriptor:
- LC100
- Effect level:
- < 1.58 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Mortality:
- 0.095 mg/l: 0/16
0.19 mg/l: 0/16
0.37 mg/l: 0/20
0.77 mg/l: 3/16
1.58 mg/l: 16/16
2.77 mg/l: 20/20
4.84 mg/l: 12/12 - Clinical signs:
- other: Signs of mild poisoning with slow recovery at low doses
- Interpretation of results:
- very toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- An LC50 value of 0.85 mg/l was determined. An LC100 value of <1.58 mg/l is also reported
- Executive summary:
The research was based on 7 sample groups of 12 -20 rats with each group receiving a different dose level of TEL. All animals displayed behaviour changes, signs of mild posioning and some had cyanosis at lower dose rates. All animals dosed at 0.37 mg/l and below survived.
Deaths started to be observed at the 0.77 mg/l dose rate with an LC50 value of 0.85 mg/l determined. Animals dosed at the higher three dose levels all died. The LC100 was reported as 1.58 mg/l.
Reference
The development of signs of toxicity from inhalation were the same as similar studies with intraveneous dosing. Hyperexcitability and continuous body tremours were observed at doses below the lethal dose.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 850 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Principles of method if other than guideline:
- Method: other (not published)
- GLP compliance:
- not specified
- Species:
- dog
- Strain:
- not specified
- Sex:
- not specified
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LDLo
- Effect level:
- ca. 547 mg/kg bw
- Interpretation of results:
- Category 1 based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 547 mg/kg bw
Additional information
The LD50 values for this material has been assessed in a number of laboratory animal studies involving oral, dermal, and injection administration, and the LC50 assessed following inhalation exposure. All study groups show similar values for each exposure type, therefore there is much supporting evidence to back up the key values used to classify the substance as very toxic even though in many cases full details of test methods are not available.
Schroeder et al. (1972) showed the oral LD50 of TEL to be 14.18 mg/kg bw in rats. The research was based on a sample group of 16 rats in four groups or four with each group receiving a different dose level of TEL by gavage. All animals displayed neurological signs including lethargy, irritability, ataxia, violent trembling and aggressiveness. In animals dosed at the higher dose levels death followed from day 6 and all animals died by the end of the study on day 14. The LD100 was 16.9 mg/kg bw.
Cremer and Callaway (1961) completed the research on the inhalation toxicity of TEL. The research was based on 7 sample groups of 12-20 rats with each group receiving a different dose level of TEL for 1 h. All animals displayed behaviour changes, signs of mild poisoning and some had cyanosis at lower dose rates. All animals dosed at 0.37 mg/L and below survived. Deaths started to be observed at the 0.77 mg/L dose rate with an LC50 value of 0.85 mg/L (equivalent to about 850 mg/m³ air) determined. Animals dosed at the higher three dose levels all died. The LC100 was reported as 1.58 mg/L.
Dermal toxicity studies by Akatsuka (1973a) in various animals gave a range of LDLo values of 547-995 mg/kg bw. Little detail can be found of the methods used. The lowest value (547 mg/kg bw) in dogs has been selected for CSA purposes. Overall, it can be concluded that shortly after acute administration, animals appear lethargic, followed by a longer period of hyperexcitability, aggressiveness and tremors. There then follows a period of hypothermia, uncoordinated behaviour, convulsions, ataxia and/or paralysis. At higher doses death occurs. Central nervous symptom effects, diarrhea, loss of body weight and reduced food intake are also reported.
At least one supporting study also notes that at higher doses, irritability, hyper-mobility, tremours, spasticity and weight loss are likely. Pathological and histopathological changes in the form of damage in the cerebral cortex, the spinal cord, the medulla oblongata, pons and hippocampus are also observed.
Justification for classification or non-classification
TEL is classified in Annex I of the DSD as R26, R27 and R28 (very toxic by inhalation, in contact with skin and if swallowed, respectively), and would be classified as acutely toxic by all routes of exposure according to EU regulations.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)