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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 May 2016 to 05 July 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Not applicable
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals No. 402 (Section 4: Health Effects) “Acute Dermal Toxicity” adopted on 24 February 1987
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 Weeks
- Weight at study initiation: 222.85 g to 236.20 g (males); 210.48 g to 216.07 g (females)
- Fasting period before study: Not applicable
- Housing: housed individually in a standard polypropylene cage (Size: L 430 x B 285 x H 150 mm)
- Diet (e.g. ad libitum): Teklad Certified (2014SC) Global 14 % Protein Rodent Maintenance Diet - Pellet, manufactured by Envigo Laboratories
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to ultraviolet rays in Aquaguard water filter with purifier
- Acclimation period: 5 Days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0 to 22.6°C
- Humidity (%): 50 to 69%
- Air changes (per hr): 12 to 15
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle
IN-LIFE DATES: From: 27 May 2016 To: 15 June 2016
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorso-lateral area of the trunk
- % coverage: 10% of the total body surface area
- Type of wrap if used: semi-occlusive dressing (crepe bandage)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): using distilled water and dried with absorbent cotton
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): Undiluted
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed for clinical signs of toxicity and mortality at 30 to 40 min, 1 hour (±10 minutes), 2 hours (±10 minutes), 3 hours (±10 minutes) and 4 hours (±10 minutes) post application of the test item on Day 1 and once daily thereafter for clinical signs of toxicity and twice daily for mortality during the experimental period.
Individual animal body weight was recorded at receipt and on Day 1 (before test item application) and on days 8 and 15 during the experimental period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- The animals did not reveal any mortality during the observation period
- Clinical signs:
- other: The animals did not reveal any clinical signs of toxicity during the observation period
- Gross pathology:
- No treatment related gross pathological findings were observed in any of the animals sacrificed at the end of the experimental period.
Any other information on results incl. tables
SUMMARY OF CLINICAL SIGNS OF TOXICITY AND MORTALITYRECORD
Test | Dose (mg/kg body weight) |
No. of Animals | Sex | Clinical Signs of Toxicity | Mortality (No. of Mortality/ No. of Animals Dosed) |
Limit Test | 2000 | 5 | M | N | 0/5 |
Limit Test | 2000 | 5 | F | N | 0/5 |
SUMMARY OF BODY WEIGHT (g) AND PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1
Test | Dose (mg/kg body weight) |
Sex | Body Weight (g) on Day 1 | Body Weight (g) on Day 8 | Body Weight (g) on Day 15 | PercentChange in Body Weight with Respect to Day 1on Day 8 | PercentChange in Body Weight with Respect to Day 1on Day 15 | ||
Limit Test | 2000 | M | Mean | 256.28 | 278.86 | 309.23 | 8.76 | 20.61 | |
±SD | 9.89 | 15.07 | 18.11 | 2.14 | 3.53 | ||||
n | 5 | 5 | 5 | 5 | 5 | ||||
Limit Test | 2000 | F | Mean | 222.74 | 231.8 | 242.25 | 4.07 | 8.76 | |
±SD | 3.58 | 3.72 | 4.82 | 0.48 | 1.11 | ||||
n | 5 | 5 | 5 | 5 | 5 |
SUMMARY OF GROSS PATHOLOGICAL FINDINGS
Test | Dose (mg/kg body weight) |
No. of Animals | Sex | Fate | External Gross Pathology Findings | Internal Gross Pathology Findings |
Limit Test | 2000 | 5 | M | TS | NAD | NAD |
Limit Test | 2000 | 5 | F | TS | NAD | NAD |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal toxicity of the registration substance was investigated according to the Guideline OECD 402. Rats were treated at dose of 2000 mg/kg bw. No effects were found. No classification is warranted.
- Executive summary:
The acute dermal toxicity of the registration substance was investigated according to the Guideline OECD 402. Five female and five male rats were treated dermally (semi-occlusive) with N,N-Dimethyl-D-Glucamine at dose of 2000 mg/kg bw for 24 hours, 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.
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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