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EC number: 947-965-2 | 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
Acute oral toxicity: LD50 >2000 mg/kg bw,
Acute dermal toxicity: LD50 > 2000 mg/kg bw
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication that meets basic scientific principles
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld
- Age at study initiation: 4 - 7 weeks old
- Weight at study initiation: male 100 - 125 g, female 90 - 115 g
- Fasting period before study: overnight
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23°C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw- Doses:
- 4 dose levels: 4000, 5040, 6350 and 8002 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 15 min, 30 min, 1 hour, 2 hours, 4 hours on day of application, once per day thereafter
weighing on day -1, 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no - Preliminary study:
- Range finding study with 3 doses: 1000, 2500, 5000 mg/kg bw,
Result: 50 % mortality at 5000 mg/kg - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 106 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 4 306 - 5 822
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 553 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- Dose 4000 mg/kg bw: mortality 2/10
Dose 5040 mg/kg bw: mortality 5/10
Dose 6350 mg/kg bw. mortality 7/10
Dose 8002 mg/kg bw: mortality 10/10 - Clinical signs:
- other: rough fur, eyes closed, sedation, diarrhoea, ataxia, ventral position, gasping, respiration increased, exophthalmos
- Gross pathology:
- The necropsy 14 days after application showed no substance related morphological visible pathologic organ findings in the survived animals.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- LD50 > 2000 mg/kg, the test item is not acute toxic following single oral application.
- Executive summary:
In an acute oral toxicity study similar to OECD guideline 401, each 5 male/ 5 female, fasted, 4 -7 weeks old Sprague-Dawley rats were given a single oral dose of the test substance by gavage at doses of 4000, 5040, 6350 and 8002 mg/kg bw and observed for 14 days. Clinical signs and death was observed in all dose groups; mortality was 2/10, 5/10, 7/10 and 10/10 in the doses 4000, 5040, 6350 and 8002 mg/kg bw, respectively. The LD50 was calculated to be 5106 mg/kg bw for the test item and 2553 mg/kg bw for the active ingredient. All surviving animals gained the expected weight at the end of the study period. No pathological changes were observed in these animals at necropsy.
Oral LD50 (rat) > 2000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 553 mg/kg bw
- Quality of whole database:
- Acceptable, well-documented study report
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Strain / Stock CD / Crl: CD(SD)
Supplier: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
Body weight (at dosing):Males: 213 - 223 g; Females: 206 - 234 g
Age (at dosing): Males: approx. 8 weeks; Females: approx. 9 weeks
Identification of animals: By coloured marks and cage label
Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) served as food. Feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum.
Periodic analysis of the food for contaminants based on EPA/USA is conducted at least twice a year by LUFA-ITL. Certificates of analysis of the composition and for contaminants were provided by the manufacturer and are included in the raw data.
Housing
Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. The cages were changed and cleaned twice a week.
Periodic analysis of the bedding material for contaminants based on EPA/USA is conducted at least once a year by LUFA-ITL (see Appendix 2 'Limitation for Contaminants in the Bedding Material').
During the 14-day observation period the animals were kept singly in MAKROLON cages (type III plus) at a room temperature of 22°C ± 3°C (maximum range) and a relative humidity of 55% ± 15% (maximum range). Deviations from the maximum range caused for example during cleaning procedures are dealt with in SOPs.
The rooms were lit (150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.
Drinking water
Drinking water in bottles was offered ad libitum.
Drinking water is examined according to the 'Deutsche Trinkwasserverordnung 2011 [German Regulations on drinking water 2011] by the Hamburger Wasserwerke, 20539 Hamburg, Germany, at least four times a year (see Appendix 2 'Limitation for Contaminants in the Drinking Water').
In addition, drinking water samples taken at LPT are analysed by LUFA-ITL once a year for means of bacteriological investigations according to the 'Deutsche Trinkwasserverordnung 2011, Anlage 1' [German Regulations on drinking water 2011, Addendum 1]. - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test item was applied once for 24 hours on the shaved intact dorsal skin of rats (5 cm x 6 cm, approx. 1/10 of body surface). This treatment was followed by an observation period of 2 weeks.
Procedure
The intact dorsal skin of the animals was shaved free of hair with a shaver approximately 18 hours before administration of the test item. The site was situated on the animal´s back between the fore and hind extremities and had an area of at least 5 cm x 6 cm (approx. 1/10 of body surface).
The test patch was occlusive. The test item was held in contact with the skin with 8 layers of gauze. The gauze was covered with a plastic sheet and secured with adhesive plaster strips on the application site for 24 hours. - Duration of exposure:
- Two weeks
- Doses:
- Dose level: 2000 mg/kg b.w. The dose level refers to the active ingredient.
Administration volume: 3.73 mL/kg b.w. - No. of animals per sex per dose:
- 5 animals/sex
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 5, 15, 30 min after administration, as well as 3, 6 and 24 hours after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology: changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central nervous system and somatomotor activity as well as behaviour pattern, were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on mortality were made at least once daily to minimize loss of animals during the study. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
The skin was observed for the development of erythema and oedema. - Preliminary study:
- not performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No deaths
- Clinical signs:
- other: None
- Gross pathology:
- No signs of abnormalities were noted at necropsy.
- Conclusions:
- The dermal LD50 in rats is greater than 2000 mg/kg bw (related to the active ingredient).
- Executive summary:
The dermal LD50 of the test substance was investigated in male and female rats according to OECD guideline 402 in a limit test. A value of > 2000 mg/kg was obtained relating to the solid content of the test substance. No deaths, clinical signs or necroscopy findings were observed.
Reference
Summarized results
Symptoms/Criteria |
Test substance 2000mg/kg b.w. (n = 5) |
|
|
males |
females |
Clinical signs |
none |
none |
Skin reactions |
none |
none |
Mortality within 6 h within 27 h within 7 d within 14 d |
0 0 0 0 |
0 0 0 0 |
Mean body weight (in g) start |
217.6 |
218.2 |
After 7 days |
275.8 (+ 26.7) |
238.6 (+ 9.3) |
After 14 days |
331.8 (+ 52.5) |
263.8 (+ 20.9) |
Inhibition of body weight gain |
none |
None |
Necropsy findings |
none |
none |
In brackets: body weight gain in %, compared to the start value
The dose level refers to the active ingredient
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- mg/kg bw
- Quality of whole database:
- Acceptable, well-documented study report
Additional information
Acute oral toxicity
In an acute oral toxicity study similar to OECD guideline 401, each 5 male/ 5 female, fasted, 4 -7 weeks old Sprague-Dawley rats were given a single oral dose of the test substanceby gavage at doses of 4000, 5040, 6350 and 8002 mg/kg bw and observed for 14 days. Clinical signs and death was observed in all dose groups; mortality was 2/10, 5/10, 7/10 and 10/10 in the doses 4000, 5040, 6350 and 8002 mg/kg bw, respectively. The LD50 was calculated to be 5106 mg/kg bw for the test item and 2553 mg/kg bw for the active ingredient.All surviving animals gained the expected weight at the end of the study period. No pathological changes were observed in these animals at necropsy.
Oral LD50(rat) > 2000 mg/kg bw
Acute Inhalation
Given that inhalation is not a relevant route of exposure, testing by the inhalation route is not necessary according to REACH Regulation Annex VIII 8.5.2 Column 2. Inhalation is not a relevant route of exposure to test substance. This applies to both workers and the general population and is due to the physicochemical properties of the substance and the nature of the products where it is used. The test substance is a waxy solid paste. Generation of inhalable particles such as dust or aerosols is therefore not to be expected. Vaporisation needs not to be considered due to the substance’s very low vapour pressure of < 1 Pa at 20 °C. The generation of aerosols is excluded by technical means or product design. The substance is not used in spray applications. The most likely route of human exposure for workers and consumers is the dermal route. Results of laboratory animal studies show a low acute toxicity of closely related substances after oral and dermal exposure. Therefore the acute intrinsic toxic activity of the test substance is considered to be low. The occurrence of a systemic toxicity relevant to humans after inhalation is unlikely and therefore the conduct of an acute inhalation toxicity study is unjustified.
According to REACH Annex XI, the conduct of an acute inhalation toxicity study is scientifically unjustified.
Results of laboratory animal studies show a very low acute toxicity after oral or dermal exposure. Therefore the acute intrinsic toxic activity of the Formamidopropylbetaine is considered to be very low. The occurrence of a systemic toxicity relevant to humans after inhalation is unlikely and therefore the conduct of an acute inhalation toxicity study is unjustified.
Furthermore, the substance is exclusively manufactured in liquid form (aqueous solution) and has a low vapor pressure, so the potential for the unintended generation of inhalable forms such as vapors is low. The generation of aerosols is excluded by technical means or product design. The most likely route of human exposure for workers and consumers is the dermal route.
Acute dermal toxicity
The study was carried out based on the guidelines OECD No 402 "Acute Dermal Toxicity".
The test substance was administered to five rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality and no systemic toxicity occurred. No signs of local skin reactions were noted among the animals. The body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals. The dermal LD50 value in rats was established to exceed 2000 mg/kg body weight for the test item.
Justification for selection of acute toxicity – oral endpoint
Data from an acceptable, well-documented study report with reliability 2.
Justification for selection of acute toxicity – inhalation endpoint
Inhalation is not a relevant route of exposure and testing by the inhalation route is not required.
Justification for selection of acute toxicity – dermal endpoint
Data from an acceptable, well-documented study report with reliability 2.
Justification for classification or non-classification
Acute oral toxicity
Based on relevant, reliable and adequate data the test substance does not need to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 and Directive 67/548/EEC with respect to acute oral toxicity.
Acute dermal toxicity
Based on relevant, reliable and adequate data the test substance has to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 and Directive 67/548/EEC with respect to acute dermal toxicity, Category 4
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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