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EC number: 810-394-3 | CAS number: 76326-99-3
- 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:
- 2015-12-15 to 2016-04-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt fĂĽr Gesundheit und Lebensmittelsicherheit, MĂĽnchen, Germany)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- k.A.
- IUPAC Name:
- k.A.
- Test material form:
- solid: flakes
- Details on test material:
- - Name of test material (as cited in study report): LICOCARE RBW 106 FL TP
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Housing and Feeding Conditions
- Full barrier in an air-conditioned room
- Temperature: 22 +/- 3 °C
- Relative humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 0446)
- Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 02102150820)
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
- Adequate acclimatisation period (at least five days) under laboratory conditions
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The animals were marked for individual identification by tail painting.
Prior to the administration a detailed clinical observation was made of all animals. Only healthy animals were used.
Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.
The test item was administered at a single dose by gavage using a feeding tube.
The test item was administered at a dose volume of 10 mL/kg body weight. - Doses:
- The starting dose was selected to be 2000 mg active component / kg body weight. No compound-related mortality was recorded for any animal of
step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required. - No. of animals per sex per dose:
- 3 per step (2 steps performed)
- Control animals:
- no
- Details on study design:
- All animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.
Weight Assessment
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
Clinical Examination
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention
given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation
period.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central
nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor,
convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Pathology
At the end of the observation period the animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally
(Narcoren®, Merial; lot no.: 250055; expiry date: 31/05/2018) at a dosage of 250-400 mg/kg bw.
All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In absence of gross pathological
changes no tissues were preserved for a possible histopathological evaluation. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the
results is not regarded as necessary.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- none
- Clinical signs:
- other: The test item showed no acute oral toxicity characteristics after a single dose administration.
- Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.
Any other information on results incl. tables
Clinical Signs - Individual Data
Step | Sex | Starting Dose (mg/kg bw) | Animal No. | Observations |
1 | Female | 2000 | 1 | no specific findings during |
the whole observation period | ||||
2 | no specific findings during | |||
the whole observation period | ||||
3 | no specific findings during | |||
the whole observation period | ||||
2 | Female | 2000 | 4 | no specific findings during |
the whole observation period | ||||
5 | no specific findings during | |||
the whole observation period | ||||
6 | no specific findings during | |||
the whole observation period |
bw = body weight
Absolute Body Weights in g and Body Weight Gain in %
Step | Animal No. / Sex | Starting Dose (mg/kg bw) | Body Weight (g) | Body Weight in Comparison | ||
Day 1 | Day 8 | Day 15 | to Day 1 (%) | |||
1 | 1 / Female | 2000 | 170 | 193 | 203 | 19 |
2 / Female | 164 | 190 | 200 | 22 | ||
3 / Female | 157 | 178 | 183 | 17 | ||
2 | 1 / Female | 2000 | 167 | 182 | 190 | 14 |
2 / Female | 170 | 194 | 197 | 16 | ||
3 / Female | 165 | 190 | 199 | 21 |
bw = body weight
Findings of the Necropsy - Individual Data
Step | Animal No. / Sex | Starting Dose (mg/kg bw) | Organ | Macroscopic Findings |
1 | 1 / Female | 2000 | - | nsf |
2 / Female | - | nsf | ||
3 / Female | - | nsf | ||
2 | 4 / Female | 2000 | - | nsf |
5 / Female | - | nsf | ||
6 / Female | - | nsf |
bw = body weight;nsf = no specific findings
LD50Cut-Off
Starting Dose (mg/kg bw) | Number of Animals | Number of Intercurrent Deaths | LD50Cut-Off |
2000 | 6 | 0 | unclassified |
bw = body weight
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral toxicity of the registration substance was investigated according to the Guideline OECD 423. Rats were treated at dose of 2000 mg/kg bw per gavage. No effects were found.
No classification is warranted. - Executive summary:
The acute oral toxicity of the registration substance was investigated according to the Guideline OECD 423. Six female rats were treated orally (per gavage) with N,N-Dimethyl-D-Glucamine at dose of 2000 mg/kg bw, observed for clinical effect, including body weight development and food consumption, for up to 14 days and subjected to necropsy. No effect was found throughout observation period and no effect was found upon gross pathological examination. No classification is warranted.
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