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1-(C12-C18 even numbered, C18 unsaturated)alkyl-1,4,5,6-tetrahydropyrimidin-2-aminium acetate and{[3-((C12-C18 even numbered, C18 unsaturated)alkylamino)propyl]amino}(imino)methanaminium acetate and[(3-{[ammonio(imino)methyl]amino}propyl)(C12-C18 even numbered, C18 unsaturated)alkylamino](imino)methanaminium diacetate
EC number: 939-650-3 | CAS number: -
- 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
In a GLP compliant OECD TG 404 study, the test item was investigated for skin irritation / corrosion properties in rabbits. Based on the results, the registration substance is considered to be corrosive to skin. Likewise, testing according to OECD TG 405 revealed that the registration substance is severely irritating to eyes. No data with regard to respiratory irritation is available. However, due to the corrosive nature, respective exposure has to be minimized.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- At this time an In-vivo study was performed and therefore covers this endpoint.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD Guideline 404.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Hoechst AG, conventional breeding- Age at study initiation: 3 - 5 month- Weight at study initiation: 2.7 - 3.3 kg- Housing: individual in stainless steel cages- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 +/- 3°C- Humidity (%): 50 +/- 20 %- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12 hour interval
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL of undiluted test item
- Duration of treatment / exposure:
- 1 hour respectively 4 hours
- Observation period:
- The evaluation was carried out 30 - 60 min and 24, 48 and 72 hours as well as 7, 14 and 21 days after the removal of the patch.
- Number of animals:
- 1 hour of exposure: 3 animals4 hours of exposure: 3 animals
- Irritation parameter:
- erythema score
- Remarks:
- 1 hour exposure
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 0.67
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Remarks:
- 1 hour exposure
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24 / 48 7 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 2.44
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 14 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- 4 hour exposure: Scare formation in one animal, no full revesibility in all animals after 21 days
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the test results of this study, the test material is considered to be corrosive to rabbit skin.
- Executive summary:
The registration substance was tested in a GLP conform study for skin irritation / corrosion according to OECD test guideline 404. For this 0.5 mL of undiluted test material was applied semi-occlusively for 1 hour or 4 hours to the shaved skin of three New Zealand White rabbits per exposure period. The skin then was examined 30 minutes, 1 hour, 24, 48 and 72 hours after removal of the dressing. Since effects were still present after 72 hours, additional readings were performed after 7, 14 (1 hour exposure group) and 21 days (4 hour exposure group).
Results for the 60 minute exposure period (3 animals): From 30 minutes to 14 days after patch removal, the treated skin sites showed mild to moderate erythema and mild to strong oedema. Between 24 hours and 14 days, the treated skin areas were cracked, dry-brittle, and scaly. Additionally scaling was observed. All signs of irritation were reversible.
Results for the 4 hour exposure period (3 animals): From 30 minutes to 21 days after application, the skin was temporarily sclerotic, vaulted, encrusted, scabby, white and brown-white discoloured. Additionally, skin induration was noted in two animals 21 days post exposure. In the remaining animal full thickness destruction of the epidermis occurred after 21 days.
Based on the results of this study, the test item was corrosive to rabbit skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- At this time a In-vivo study was performed and therefore covers this endpoint.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD Guideline 405.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Hoechst AG, conventional breeding- Age at study initiation: 3 - 5 month- Weight at study initiation: 3.5 - 3.8 kg- Housing: individual in stainless stell cages- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 +/-3°C- Humidity (%): 50 +/- 20 %- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12 hour interval
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL of the undiluted test item
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 24 hours (due to severe eye irritation reactions study was terminated after this reading)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- 24 hours in advance to the study, the later tested eye of each rabbit was treated with fluoresceine Na-salt (0.01%) in order to check the cornea concerning defects. Only animals without diagnostic findings regarding the cornea were choosen for further testings.For the study 0.1 mL of the test item (concentration is 78 %; composition reported in confidential details on test material) was applied to the conjunctival sac of the left eye of each testing animal. The non treated eye served as control eye.Damages on the cornea, the iris and on the conjunctiva were numerical evaluated. All other changes were also recorded.
- Irritation parameter:
- cornea opacity score
- Remarks:
- all animals
- Basis:
- mean
- Remarks:
- over all
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: study terminated due to the severity of findings
- Irritation parameter:
- iris score
- Remarks:
- all animals
- Basis:
- mean
- Remarks:
- overall
- Time point:
- other: 24 hours
- Remarks on result:
- other: not assessable due to severe opacity of cornea
- Irritation parameter:
- conjunctivae score
- Remarks:
- all animals
- Basis:
- mean
- Remarks:
- overall
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: study terminated due to severity of findings
- Irritation parameter:
- chemosis score
- Remarks:
- all animals
- Basis:
- mean
- Remarks:
- over all
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: study terminated due to severity of findings
- Irritant / corrosive response data:
- At the 24 hour reading severe eye irritation in form of opaque cornea, non assessable iris and severe chemosis including white discoloration of conjunctivae occurred. Based hereupon the study was terminated and the animals humanly killed.
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the study results, the test material is considered to be severly irritating to rabbit eyes.
- Executive summary:
In an OECD TG 405 study, 0.1 ml of the test material was applied to the eye of 3 New Zealand White rabbit. From 1 hour onwards, the conjunctiva showed red beefy discoloration and pronounced chemosis. The cornea exhibited opalescent areas or was opaque with no details of the iris visible. Because these lesions had progressed at the 24 hour reading, the study was terminated and the animals humanly killed for animal welfare reasons. Accordingly, the test item has to be considered as severely irritating to eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The registration substance was tested in a GLP conform study for skin irritation / corrosion according to OECD test guideline 404. For this 0.5 mL of undiluted test material was applied semi-occlusively for 1 hour or 4 hours to the shaved skin of three New Zealand White rabbits per exposure period. The skin was examined 30 minutes, 1 hour, 24, 48 and 72 hours after removal of the dressing. Since effects were still present after 72 hours, additional readings were performed after 7, 14 (1 hour exposure group) and 21 days (4 hour exposure group). Results for the 60 minute exposure period (3 animals): From 30 minutes to 14 days after patch removal, the treated skin sites showed mild to moderate erythema and mild to strong oedema. Between 24 hours and 14 days, the treated skin areas were cracked, dry-brittle, and scaly. Additionally scaling was observed. Results for the 4 hour exposure period (3 animals): From 30 minutes to 21 days after application, the skin was temporarily sclerotic, vaulted, encrusted, scabby, white and brown-white discoloured. Additionally, skin induration was noted in two animals 21 days post exposure. In the remaining animal full thickness destruction of the epidermis occurred after 21 days. Based on the results of this study, the test item was corrosive to rabbit skin.
In an OECD TG 405 study, 0.1 ml of the test material was applied to the eye of 3 New Zealand White rabbit. From 1 hour onwards, the conjunctiva showed red beefy discoloration and pronounced chemosis. The cornea exhibited opalescent areas or was opaque with no details of the iris visible. Because these lesions had progressed at the 24 hour reading, the study was terminated and the animals humanly killed for animal welfare reasons. Accordingly, the test item has to be considered as severely irritating to eyes.
Justification for selection of skin irritation / corrosion endpoint:
Guideline study according to GLP with a Klimisch rating 1.
Justification for selection of eye irritation endpoint:
Guideline study according to GLP with a Klimisch rating 1.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Based on the results of guideline conform testing, the registration substance has to be considered as skin corrosive and is classified as `skin corrosive` subcategory 1C with the designation H314 - causes severe skin burns and eye damage according to GHS-CLP (equivalent to EU risk phrase `R34 - causes burns` according to DSD)
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.
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