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EC number: 230-908-4 | CAS number: 7365-82-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12th November 2018 - 27th November 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17th December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance Document on Acute Oral Toxicity Testing, OECD Series on Testing and Assessment
- Version / remarks:
- No 24, 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. Environmental Health and Safety Publications Series on Testing and Assessment
- Version / remarks:
- No 19, 2000
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- N-(carbamoylmethyl)taurine
- EC Number:
- 230-908-4
- EC Name:
- N-(carbamoylmethyl)taurine
- Cas Number:
- 7365-82-4
- Molecular formula:
- C4H10N2O4S
- IUPAC Name:
- N-(carbamoylmethyl)taurine
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Lot Number: GL865320171205
Composition: 2-((2-Amino-2-oxoethyl)amino)ethanesulfonic acid
CAS No: 7365-82-4
Molecular formula: C4H10N2O4S
Purity: >=99% Assay (Titration)
Appearance: White crystalline powder
Homogeneity: homogeneous
Production Date: 5th December 2017
Expiry Date: 5th December 2019
Storage: Room Temperature (20 ± 5 °C)
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female animals were non-pregnant and nulliparous, 8-12 weeks of age at first dose.
Health condition of animals was examined by a veterinarian before initiation of the study.
The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air-conditioning. The average room temperature was maintained within the range of 22 ± 3 ° C, relative humidity within 50-60 %. The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was performed according to the standard operation procedures.
The laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered at recommended doses each day approximately at the same time.
The animals received tap water for human consumption. Drinking water was supplied ad libitum.
The animals in the cage were marked by a line (I-III) on the tail with a waterproof marker. Each cage was marked with the study code, ID of animals and date of administration of the substance.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- The substance was administered in a single dose by gavage using a metal stomach tube (administration volume 5 mL/kg). Animals were fasted prior to dosing (food but not water were withheld over-night). Following a period of fasting, animals were weighed and the substance administered. After substance administration, food was withheld for further 3-4 hours.
- Doses:
- Single dose of 2000 mg/kg body weight.
- No. of animals per sex per dose:
- 6 females (3/step)
- Control animals:
- no
- Details on study design:
- Available information indicated that the substance is likely to be non-toxic with regard to acute toxicity.A limit dose of 2000 mg/kg body weight was therefore used as a starting dose. One group of 3 females was dosed. Substance-related mortality was not observed during 24 hours and therefore, in a second step, another 3 females were treated at the same dose level.
The required amount of the substance (according to the body weight) was mixed with vehicle (olive oil) shortly before administration. The substance was administered in a single dose by gavage using a metal stomach tube (administration volume 5 mL/kg). Animals were fasted prior to dosing (food but not water were withheld over-night). Following a period of fasting, animals were weighed and the substance administered. After substance administration, food was withheld for further 3-4 hours.
Animals were observed individually immediately after administration of the substance and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days.
Observations included: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Individual weights of animals were measured immediately prior to substance administration and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.
All test animals were subjected to gross necropsy and the results were recorded for each animal.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.
- Clinical signs:
- other: No signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period.
- Gross pathology:
- All animals were necropsied. During necropsy, no macroscopic findings were observed.
Any other information on results incl. tables
Clinical Observation
Sex |
Dose |
ID |
Administration Result |
Clinical Observation |
♀ |
2000 mg/kg |
1 |
alive |
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period |
2 |
alive |
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period |
||
3 |
alive |
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period |
||
4 |
alive |
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period |
||
5 |
alive |
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period |
||
6 |
alive |
no signs of intoxication, change of health, nor any other adverse reactions during 24 hours and 14-days observation period |
Body Weight
Sex |
Dose |
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
Initial |
Week 1 |
Week 2 |
Week 1-Initial |
Week 2-Initial |
Week 2-Week 1 |
|||
♀ |
2000 mg/kg |
1 |
203 |
217 |
229 |
14 |
26 |
12 |
2 |
200 |
215 |
222 |
15 |
22 |
7 |
||
3 |
207 |
203 |
208 |
- 4 |
1 |
5 |
||
4 |
225 |
234 |
241 |
9 |
16 |
7 |
||
5 |
224 |
234 |
243 |
10 |
19 |
9 |
||
6 |
223 |
237 |
244 |
14 |
21 |
7 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 in an acute toxicity study conducted on the substance in female rats administered via gavage is >2000 mg/kg bw.
- Executive summary:
In a reliable in vivo acute oral toxicity study, the substance was administered to 6 female Wistar rats in a single dose by oral gavage at a limit dose of 2000 mg/kg body weight. All (6/6 females) animals survived the dose of 2000 mg/kg body weight. The substance did not cause death or evident signs of toxicity. During the observation period of 14 days, no other signs of intoxication, change of health, nor any other adverse reactions were seen. Macroscopic examination of the animals at the end of the study did not reveal treatment-related changes. The LD50of the substance is considered to be greater than 2000 mg/kg body weight after single oral administration to female Wistar rats.
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