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EC number: 604-759-4 | CAS number: 150928-21-5
- 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
Oral (Rat-Wistar, GLP, non-audited report, OECD TG 423): LD50 > 2000 mg/kg [Schering AG, 1993-05-17]
Dermal (Rat-Wistar, GLP, non-audited report, OECD TG 402 and 404): LD50 > 2000 mg/kg [Schering AG, 1994-05-25]
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:
- 1992-03-24 to 1993-05-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Qualifier:
- according to guideline
- Guideline:
- other: "New approaches to acute toxicity testing of chemicals" (Bundesgesundheitsblatt 32, pp. 336-340, 1989).
- Version / remarks:
- 1989
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG- Age at study initiation:
- Weight at study initiation: 85-92 g males; 87-104 g females
- Housing: individually under conventional conditions
- Fasting period before study: 18-19 h
- Diet (e.g. ad libitum): adlibitum: pel. Atromin R®
- Water (e.g. ad libitum): ad libitum: demineralized, acidified water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
IN-LIFE DATES: From: 24.03.1992 To: 19.04.1992 - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.9 g NaCl + 0.085 g Mrj ad 100 mL demin. water
- Doses:
- 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: day 1, 7 or 8 and 14
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- 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.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 of TIP-Diamidchlorid in male and female rats after a single i.g. application is > 2000 mg/kg body weight.
- Executive summary:
In an acute oral toxicity study according to "New approaches to acute toxicity testing of chemicals" (Bundesgesundheitsblatt 32, pp. 336-340, 1989)., groups of fasted, young adult Wistar rats (3/sex) were given a single oral dose of TIP-Diamidchlorid (100% a.i.) in 0.9 g NaCl + 0.085 g Mrj ad 100 mL demin. water at a dose of 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined > 2000 mg/kg bw
No mortality occurred during this limit test.
There were no treatment related clinical signs, necropsy findings or changes in body weight.
TIP-Diamidchlorid is of LOW Toxicity based on the LD50 in both male and female rats.
Reference
The single i.g. application of 2000 mg test item/kg was tolerated by all treated animals without any clinical findings. The body weight gain observed on day 7 (male) or 8 (female) and at the end of the test on day 14 was within the normal range for rats (M+F) of the age and strain which are routinely used in our laboratory. Autopsy revealed no compound-related or suspected compound-related findings.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Quality is high, guideline study
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:
- 1994-02-23 to 1994-03-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- As described in Schlede, E. et al.: A national validation study of the acute-toxic-class method - an alternative to the LD59 test Arch. Toxicol. 66, 455-470, 1992
- GLP compliance:
- yes
- Test type:
- other: similar to Acute toxic class
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: Males: 84-92 g; Females: 99-102 g
- Fasting period before study: 18-19.5 h
- Housing: individually under conventional conditions
- Diet (e.g. ad libitum): ad libitum: Pell. Altromin® R
- Water (e.g. ad libitum): ad libitum: Demineralized acidified water, pH 2-3
- Acclimation period: 7 days males; 9 days females
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 56-62
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23.02./25.02.1994 To: 08.03./10.03.1994 - Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
I 194 mg test item + 0.16 mL vehicle-1)
ll 169 mg test item + 0.17 mL vehicle-1)
lll 180 mg test item + 0.18 mL vehicle-1)
IV 204 mg test item + 0.24 mL vehicle-1)
1 v 19a mg test item + 0.21 mL vehicle-1)
1 Vl 200 mg test item + 0.23 mL vehicle-1)
1) Vehicle: 0.9% (w/v) NaCl-solution
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 1, 7 and 14
- Necropsy of survivors performed: no
- 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.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 of TIP-Diamidchlorid in male and female rats after a single dermal application is > 2000 mg/kg body weight.
- Executive summary:
In an acute dermal toxicity study according to Schlede, E. et al.: A national validation study of the acute-toxic-class method - an alternative to the LD59 test Arch. Toxicol. 66, 455-470, 1992 and EEC Commission Directive no. 79/831 EEC of 18. Sep. 1979 (equivalent to the corresponding German regulations), groups of young adult Wistar rats (3/sex) were dermally exposed to TIP-Diamidchlorid (100% a.i) in 0.9% NaCl for 24 hours at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined > 2000 mg/kg bw
No mortality occurred in this limit test.
There were no treatment related clinical signs, necropsy findings or changes in body weight.
TIP-Dichlorid is of LOW Toxicity based on the LD50 in male and female Wistar rats.
Reference
The single dermal application of 2000 mg/kg of the test item was tolerated without compound-related clinical findings. The slight to moderate swelling of both forelimbs in one female animal on days 2 and 3 is not considered to be compound-related. It was probably caused by the bandage used for dermal exposure. A higher dosage than 2000 mg/kg was not tested in the present study since this dose level is established as the upper limit dose for classification and labelling requirements concerning dangerous substances in accordance with the EEC Commission Directive no. 79/831 EEC of 18. Sep. 1979 (equivalent to the corresponding German regulations). The body weight gain observed on day 7 and at the end (day 14) of the test was within the normal range for rats (M+F) of the age and strain which are routinely used in the laboratory. On day 14 of the test all surviving animals were sacrificed without showing any compound-related clinical findings.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Quality high, guideline study
Additional information
The single oral administration of ZK91445 to male and female Wistar rats was well tolerated without any treatment-related findings. Acute oral toxicity of ZK 91445 in Wistar rats is above 2000 mg/kg body weight.
The single dermal administration of ZK 91445 to male and female Wistar rats was well tolerated without any treatment-related findings. Acute dermal toxicity of ZK91445 is above 2000 mg/kg body weight.
Justification for classification or non-classification
Based on the available data the substance does not need to be classified according to Regulation (EC) No. 1272/2008 (CLP) with regard to acute oral or dermal toxicity.
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