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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 201-302-7 | CAS number: 80-70-6
- 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://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEC = systemic NOAEL (OECD422, rat) *abs. oral/abs. inhal. /0.38 m3/kg bw *6.7 m3/10 m3 = NOAEL /(2*0,38) *0.67 (see R.8.4.2)
- AF for dose response relationship:
- 1
- Justification:
- GLP OECD guideline study with 3 doses
- AF for differences in duration of exposure:
- 6
- Justification:
- default factor for subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default after extrapolation from oral route to inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL (dermal) = systemic NOAEL (oral, OECD 422 rat) * 1 (100 % resorption = worst case)
- AF for dose response relationship:
- 1
- Justification:
- GLP OECD guideline study with 3 doses
- AF for differences in duration of exposure:
- 6
- Justification:
- default factor for subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default for scaling from rat to man
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 5
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General considerations
1,1,3,3-Tetramethylguanidine (TMG), CAS 80-70-6 is a liquid with a MW of 115.1768 g/mol and a vapour pressure of 2.9 hPa @20 °C. Thus, the saturated vapour concentration is calculated to be 13.8 mg/L. It is miscible with water at any ratio and has a log Pow of -0.49 @20 °C. With a pH > 12.5 is is a strong alkaline substance.
In animal studies TMG is harmful after single ingestion (LD50 (oral, rat) = 835 mg/kg; 1982), and corrosive to the skin (study similar to OECD TG 404; 1982). TMG is not expected to be skin sensitizing (QSAR, 2017) and was not mutagenic in bacteria and mammalian cell culture (Ames: 2015; HPRT: 2018 and in vitro MNT, 2017).
For TMG an oral OECD422 study in rat is available with doses of 0, 10, 30 and 100 mg/kg bw /d administered per gavage (2018). The observed adverse findings were erosions in the glandular stomach of some females in the mid and high dose group and considered to be local effects resulting from the basic corrosive properties of TMG. Therefore, the systemic NOAEL in this study is 100 mg/kg bw/d and the local NOAEL is 10 mg/kg bw/d.
DNEL derivation: Point of departure
For the DNEL derivation the strong corrosivity of the substance is considered to be the most sensitive effect. Quantitative data (dose response) on this hazard are available for the oral route from acute and repeated dose toxicity, but not for the dermal or inhalation route. Therefore, no local (long term or acute/short term) DNELs and no systemic short term DNELs were derived. Systemic long-term DNELs for inhalation and dermal route were derived using the systemic NOAEL of the oral OECD422 study in rats as the dose descriptor starting point. These DNELs are only relevant in preparations when the corrosivity of the substance is not anymore the most prominent effect (concentration < 1%).
As TMG is classified as Skin Corr. 1B, H314 (GHS EU), it is attributed to the moderate hazard class according to ECHA Guidance E (v3.0, May 2016) and ECHA Guidance R.8 (v.2.1, Nov 2012). Appropriate OCs (operational conditions), RMMs (risk management measures) and PPE (personal protection equipment) should therefore be implemented, when developing exposure scenarios.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 43.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEC = systemic NOAEL (OECD422, rat) / [sRV * time] *(abs. oral/abs. inhal.) = NOAEL / [0.8 L/min/kg bw rat * 24*60 min] *50%/100% = NOAEL /(1.15 m3/kg bw *2)
- AF for dose response relationship:
- 1
- Justification:
- GLP OECD guideline study with 3 doses
- AF for differences in duration of exposure:
- 6
- Justification:
- default for subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default after extrapolation from oral route to inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
100% resorption (worst case): *1
- AF for dose response relationship:
- 1
- Justification:
- GLP OECD guideloine study with 3 doses
- AF for differences in duration of exposure:
- 6
- Justification:
- default for subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default for scaling from rat to man
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- other: no modification neccessary
- AF for dose response relationship:
- 1
- Justification:
- GLP OECD guideline study
- AF for differences in duration of exposure:
- 6
- Justification:
- default for subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default for scaling from rat to man
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
see "Additional information - Workers"
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.
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