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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-302-7 | 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
Endpoint summary
Administrative data
Description of key information
- corrosive to the skin
- classification for skin corrosion leads to classification for serious eye damage (cat. 1)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 May 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (occlusive dressing; no information on skin reactions after 3 min of exposure)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Morton Commercial Rabbits, Parsonage Farm, Stansted, Essex, UK
- Age at study initiation: at least 11 weeks
- Weight at study initiation: 3.46 kg
- Housing: single in a grid floor cage
- Diet: Standard Rabbit Diet (Special Diets Services Ltd., Stepfield, Witham, Essex, UK), ad libitum
- Water: mains water, ad libitum
- Acclimation period: at least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13 - 20
- Humidity (%): 40 - 47
- Photoperiod (hrs dark / hrs light): 10 / 14 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 1 h (the study was terminated after 1 h for humane reasons)
- Observation period:
- The study was terminated after 1 h of treatment for humane reasons.
- Number of animals:
- 1 female animal (owing to the very high pH of the diluted test article)
- Details on study design:
- TEST SITE
- Area of exposure: back (6 cm2)
- Type of wrap if used: gauze patch; the patch was occluded and secured using a strip of impermeable adhesive tape (Sleek, Smith & Nephew, Welwyn Garden City, Herts, UK)
REMOVAL OF TEST SUBSTANCE
- Washing: The skin wiped gently with a disposable paper towel moistened with water.
- Time after start of exposure: 1 h
SCORING SYSTEM: Immediately on removal of the patches severe tissue damage was observed. No scoring of the skin irritation could be made. The animal was killed and the study terminated for humane reasons. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- > 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: corrosive
- Remarks:
- The study was terminated after 1 h and the severe tissue damage precluded any scoring of erythema or edema. The animal was killed for humane reasons and the study terminated. Hence, reversibility of the local effects could not be determined.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- > 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: corrosive
- Remarks:
- The study was terminated after 1 h and the severe tissue damage precluded any scoring of erythema or edema. The animal was killed for humane reasons and the study terminated. Hence, reversibility of the local effects could not be determined.
- Irritant / corrosive response data:
- Vocalisation was noted 2 minutes after application of the test article. The patch was removed after one hour and the severe tissue damage precluded any scoring of erythema or edema. The animal was killed for humane reasons and the study terminated.
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Skin corr. 1B, H314
- Executive summary:
The study was performed 1982, following the DOT (Transport Classification) Guidelines. The study was terminated after 1 h and the animal was killed for humane reasons. Therefore, the substance is classified as skin corrosive 1B, H314 according to Regulation (EC) 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The skin irritation study was performed 1982, following the DOT (Transport Classification) Guidelines.The study was terminated after 1 h and the animal was killed for humane reasons. Therefore, the substance is classified as skin corrosive 1B, H314 according to Regulation (EC) 1272/2008.
Eye irritation:
According to Column 2 of REACH Annex VII an in vivo eye irritation study (required in Section 8.2 of REACH Annex VII) does not need to be conducted if 1) the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes, or 2) the substance is flammable in air at room temperature. As the test substance is a strong base (pH > 11.5) and meets the classification criteria both for Skin corr. 1B, H314 and Flam. Liquid 3 according to Regulation EC 1272/2008, no eye irritation study is needed to fulfill the data requirements defined in REACH Annex VII.
Justification for classification or non-classification
Due to the reuslts of an in vivo skin irritation study, tetramethylguanidine is classified as skin corrosive 1B, H314 according to the regulation (EC) 1272/2008 (CLP).
According to the REACH regulation (EC) 1907/2006, annex VII, 8.2. column 2, no eye irritation study is needed because the test substance is a strong base (pH > 11.5) and meets the classification criteria both for Skin corr. 1B, H314 and Flam. Liquid 3 according to Regulation EC 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.