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EC number: 606-946-6 | CAS number: 221640-14-8
- 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
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- 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
LD50 oral (rat):> 300 < 2000 mg/kg bw [report, Lewin 2005]
LD50 dermal (rat): > 2000 mg/kg bw [report, Lewin 2004]
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:
- from February 2004 to April 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- yes
- Remarks:
- - according to the replaced version (1996) of the OECD TG 423 both sexes and a starting dose of 200 mg/kg bw were used
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: HAN: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River, Berlin - Buch, Germany
- Mean weight at study initiation: 104-106 g (males) or 94-106 g (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least >=7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 23
- rel. Humidity (%): 48 - 56
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- other: 9 mg NaCl ad 1 ml Aqua p.i.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- 200 mg/kg bw and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed at five (200 mg/kg bw) or nine (2000 mg/kg bw) different time points on administration day and then once daily until day 14. Body weight was recorded weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The LD50 value was determined according to the replaced version (1996) of OECD test guideline 423. According to Regulation (EU) No. 1272/2008 the LD50 value is >300 and < 2000 mg/kg bw, corresponding to GHS Category 4
- Mortality:
- No mortality was observed after adiministration of 200 mg/kg bw in both sexes. After 2000 mg/kg bw all animals died between 4 hours after treatment and the following day of the study.
- Clinical signs:
- other: The main clinical findings after administration of 2000 mg/kg were increased sialorrhea and compulsive behavior five minutes after administration. Apathy, abnormal respiration and eyelid closure were also observed in the first hour after administration. L
- Gross pathology:
- Necropsy of the rats which died after administration of 2000 mg/kg revealed reddening or dark-red discoloration of the gastro-intestinal mucosa (small intestine). There were no abnormal necropsy findings in male and female rats dosed at 200 mg/kg bw.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral toxicity of the test item was moderate with an LD50 value of > 300 < 500 mg/kg bw in rats according to ANNEX 3b of OECD TG 423 (1996). All males and females dosed with 200 mg/kg bw survived. After 2000 mg/kg bw all animals died between 4 hours after treatment and the following day of the study. Clinical findings beyond 5 minutes after aopplication were limited to the 2000 mg/kg bw dose group. Body weight development was not affected. During autopsy reddening or dark-red discoloration of the gastro-intestinal mucosa (small intestine) were described for the animals which died after application of 2000 mg/kg
- Executive summary:
In an acute oral toxicity study according to OECD guideline 423 (1996), groups of, adult male and female WST (SPF) rats (3/sex) were given a single oral dose of Z-Triamine Dihydrochloride in 900 mg NaCl + 85 mg Myrj 53 ad 100 ml bidist. water at doses 2000 (only female) and 200 mg/kg bw (female and male) and observed for 14 days.
Oral LD50 Combined = > 300 mg/kg bw and < 2000 mg/kg bw (according to Regulation (EU) No. 1272/2008 (CLP))
Oral LD50 Combined = > 300 mg/kg bw and < 500 mg/kg bw (according to OECD Test Guideline 423 Annex 3c (1996))
All females died after oral ingestion of 2000 mg/kg bw. All males and females dosed with 200 mg/kg bw survived. Clinical findings were limited to the 2000 mg/kg bw dose group. Body weight development was not affected. Autopsy revealed reddening of the glandular mucosa of the stomach in only one animal which died after application of 2000 mg/kg and no compound-related or suspected compound-related findings in the two other animals which died or in the animals which were sacrificed at the end of the study.
Z-Triamine Dihydrochloride is of low Toxicity based on the LD50 in WIST (SPF) rats. The substance is classified according to Regulation (EU) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) as Category 4 ‘harmful if swallowed’.
Reference
clinical findings
Dose of test item | Sex | Findings | Numberof animals with findings/number of surviving animals | |||||||||
Day 1 (min after administration | ||||||||||||
5 | 15 | 30 | 60 | 120 | 180 | 210 | 240 | p.m. | Day 2-14 | |||
200 | M | Compulsive behaviour | 2/3 |
|
|
|
|
|
|
|
|
|
Increased sialorrhea | 3/3 |
|
|
|
|
|
|
|
|
| ||
Without findings | 0/3 |
| 3/3 | 3/3 |
| 3/3 |
|
| 3/3 | 3/3 | ||
F | Compulsive behaviour | 1/3 |
|
|
|
|
|
|
|
|
| |
Increased sialorrhea | 2/3 |
|
|
|
|
|
|
|
|
| ||
Without findings | 1/3 |
| 3/3 | 3/3 |
| 3/3 |
|
| 3/3 | 3/3 | ||
2000 | F | Increased sialorrhea | 3/3 |
|
|
|
|
|
|
|
|
|
Apathy, slight |
| 2/3 | 3/3 | 3/3 |
|
|
|
|
|
| ||
Apathy, moderate |
|
|
|
| 3/3 | 3/3 | 1/3 | 1/2 |
|
| ||
Apathy, severe |
|
|
|
|
|
| 2/3 | 1/2 | 1/1 |
| ||
Prone, lateral or supine position, conscious |
|
|
|
|
|
| 1/3 |
|
|
| ||
Compulsive behaviour | 3/3 | 1/3 |
|
|
|
|
|
|
|
| ||
Gait spastic |
|
|
|
| 3/3 | 3/3 | 2/3 | 2/2 | 1/1 |
| ||
Respiration retarded |
| 3/3 | 3/3 | 3/3 | 3/3 | 3/3 | 3/3 | 2/2 | 1/1 |
| ||
Abnormal breathing sounds |
| 1/3 | 1/3 | 1/3 | 1/3 | 1/3 | 1/3 | 1/2 | 1/1 |
| ||
Eyelid closure |
| 1/3 | 2/3 | 3/3 | 3/3 | 3/3 | 3/3 | 2/2 | 1/1 |
| ||
Secretion, serous |
|
|
|
|
| 2/3 | 2/3 | 2/2 | 1/1 |
| ||
Fur ruffled |
|
|
|
| 3/3 | 3/3 | 3/3 | 2/2 | 1/1 |
| ||
Discolouration of eyes, dark reddish |
|
|
|
| 3/3 | 3/3 | 3/3 | 2/2 | 1/1 |
| ||
Discolouration of fore and hind limbs, bluish |
|
|
|
|
|
| 3/3 | 2/2 | 1/1 |
| ||
Without findings | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/2 | 0/1 | 0/0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
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:
- from February 2004 to April 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- yes
- Remarks:
- - 3 instead of 5 animals/sex used
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: HAN: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG, Germany
- Mean weight at study initiation: 287-314 g (males) or 198-205 g (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- rel. Humidity (%): 48 - 57
- Photoperiod (hrs dark / hrs light): 12 / 12 - Type of coverage:
- occlusive
- Vehicle:
- other: 9 mg NaCl ad 1 mL aqua p.i.
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The test substance was applied on a piece of gauze covering approximately 10% (4 x 9 cm) of the animal body surface under occlusive conditions for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A paste consisting the original compound (group 2: 79.2-125.8 mg, group 3: 400.0-590.2 mg) and 0.9% (w/v) sodium chloride (group 2: 0.05-0.075 mL, group 3: 0.30-0.35 mL)
was administered.
- Constant volume or concentration used: yes
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.05 mL to 0.35 mL - Duration of exposure:
- 24 hours
- Doses:
- 400, 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
General findings:
All alterations of the baseline condition of the animals were recorded. All animals were checked four times on administration day and once daily on the following days up to day 14 of the test.
Local findings:
All alterations of the skin at the administration sites of all animals were recorded according to the scoring system recommended by the EU (Amendment of the Directive 67/548/EEC, Annex V, B.4. Acute toxicity (Skin irritation) in the version of the Directive 92/69/EEC, dated 31 Jul 1992.). The application sites were evaluated 1, 24, 48 and 72 h after removal of the patches and then once daily until day 14 of the test.
Body weight
Body weight was determined at the start (day 1), on day 8 and at the end of the study (day 14).
- Necropsy of survivors performed: yes; the animals were sacrificed 14 days post administration by inhalation of carbon dioxide and after occurrence of death a complete postmortem examination was performed on each animal.
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All treated animals survived at both doses.
- Clinical signs:
- other: no clinical findings at both doses.
- Gross pathology:
- Autopsy revealed no compound-related findings.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A single dermal administration of the test substance to male and female rats at 400 mg/kg and 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, sustained effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study similar to OECD TG 402 (adopted 24 February 1987), groups of young adult Wistar rats (3/sex) were dermally exposed to Z-Triamine Dihydrochloride in physiological saline for 24 hours at doses of 400 and 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined = > 2000 mg/kg bw
The test item is of low Toxicity based on the combined LD50 value of > 2000 mg/kg bw.
The treatment was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. Local effects were observed only for the 2000 mg/kg bw treatment group.
Reference
Dose [mg/kg] | Sex | Findings | Numberof animals with findings/number of surviving animals | ||||||||||||
Days after administration(hours after removal of the patches) | |||||||||||||||
2 (1) | 3 (24) | 4 (48) | 5 (72) | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | |||
400 | M | without findings | 3/3 | 3/3 | 3/3 | 3/3 | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. |
F | without findings | 3/3 | 3/3 | 3/3 | 3/3 | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | |
M | Pustules spotty |
| 2/3 |
|
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|
|
|
| |
Pustules, plain |
| 1/3 |
|
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|
|
|
|
|
|
|
| ||
Scab formation, spotty |
| 1/3 | 1/3 | 1/3 | 1/3 | 2/3 | 2/3 | 1/3 | 1/3 | 1/3 | 1/3 |
|
| ||
Scab formation, plain |
|
|
| 1/3 | 1/3 | 1/3 | 1/3 | 1/3 | 1/3 | 1/3 | 1/3 |
|
| ||
2000 | Scab formation, total treated area |
| 2/3 | 2/3 | 1/3 | 1/3 |
|
|
|
|
|
|
|
| |
without findings | 3/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 1/3 | 1/3 | 1/3 | 1/3 | 3/3 | 3/3 | ||
F | Reddening. sporadic, punctiform | 3/3 | 3/3 | 3/3 | 3/3 | 2/3 | 2/3 | 1/3 | 1/3 | 1/3 | 1/3 | 1/3 |
|
| |
Scab formation, spotty |
| 2/3 | 2/3 | 2/3 | 1/3 | 1/3 | 1/3 | 1/3 |
|
|
|
|
| ||
Skin defect -only outside of the treated area |
|
|
|
|
|
|
| 2/3 | 2/3 | 2/3 | 1/3 | 2/3 |
| ||
without findings | 0/3 | 0/3 | 0/3 | 0/3 | 1/3 | 1/3 | 2/3 | 0/3 | 0/3 | 0/3 | 1/3 | 1/3 | 3/3 |
M = male
F = female
n.d. = not detected
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Acute toxicity: oral
In an acute oral toxicity study according to OECD guideline 423 (1996), groups of, adult male and female WST (SPF) rats (3/sex) were given a single oral dose of Z-Triamine Dihydrochloride in 900 mg NaCl + 85 mg Myrj 53 ad 100 ml bidist. water at doses 2000 (only female) and 200 mg/kg bw (female and male) and observed for 14 days.
Oral LD50 Combined = > 300 mg/kg bw and < 2000 mg/kg bw (according to Regulation (EU) No. 1272/2008 (CLP))
Oral LD50 Combined = > 300 mg/kg bw and < 500 mg/kg bw (according to OECD Test Guideline 423 Annex 3c (1996))
All females died after oral ingestion of 2000 mg/kg bw. All males and females dosed with 200 mg/kg bw survived. Clinical findings were limited to the 2000 mg/kg bw dose group. Body weight development was not affected. Autopsy revealed reddening of the glandular mucosa of the stomach in only one animal which died after application of 2000 mg/kg and no compound-related or suspected compound-related findings in the two other animals which died or in the animals which were sacrificed at the end of the study.
Z-Triamine Dihydrochloride is of low Toxicity based on the LD50 in WIST (SPF) rats. The substance is classified according to Regulation (EU) No. 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) as Category 4 ‘harmful if swallowed’.
Acute dermal toxicity:
In an acute dermal toxicity study similar to OECD TG 402 (adopted 24 February 1987), groups of young adult Wistar rats (3/sex) were dermally exposed to Z-Triamine Dihydrochloride in physiological saline for 24 hours at doses of 400 and 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined = > 2000 mg/kg bw
The test item is of low Toxicity based on the combined LD50 value of > 2000 mg/kg bw.
The treatment was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. Local effects were observed only for the 2000 mg/kg bw treatment group.
Justification for classification or non-classification
Acute toxicity: oral
LD50: > 300 - < 2000 mg/kg bw (rat, female/male)
According to Regualtion EU-No.1272/2008 (CLP), Z-Triamin-Dihydrochlorid shall be classified as harmful if swallowed Category 4.
Acute toxicity: inhalation
No data available
Acute toxicity: dermal
LD50: > 2000 mg/kg bw (rat, female/male)
No classification required according to Regulation (EC) No 1272/2008, Annex I
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