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EC number: - | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 February 2022 to 11 March 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- OECD Guideline for Testing of Chemicals No. 402 (Section 4: Health Effects) “Acute Dermal Toxicity: Fixed Dose Procedure” adopted on 09 October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- D-Glucitol, anhydro-1-deoxy-1-(methylamino)-, N-[C12-14(even numbered) acyl] derivs.
- Molecular formula:
- C19H37NO5 C21H41NO5
- IUPAC Name:
- D-Glucitol, anhydro-1-deoxy-1-(methylamino)-, N-[C12-14(even numbered) acyl] derivs.
- Test material form:
- semi-solid (amorphous): gel
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Clariant and S148866
- Expiration date of the batch: 30.09.2022
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No
- Final preparation of a solid: applied as such
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house bred
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 11 weeks
- Weight at study initiation: 200.45 g to 201.69 g
- Fasting period before study: No
- Housing: polysulphonate cage (size: L 430 x B 280 x H 210 mm)
- Diet (e.g. ad libitum): Yes
- Water (e.g. ad libitum): Yes
- Acclimation period: 18 Feb 2022 to 24 Feb 2022
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0°C to 22.8°C
- Humidity (%): 44% to 66%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle
IN-LIFE DATES: From: 18 Feb 2022 To: 11 Mar 2022
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 6 cm × 10 cm
- % coverage: 10% of the total body surface
- Type of wrap if used: crepe bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 24 Hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 420.3 mg for range-finding study; 439.3 and 440.3 mg for main study
- Constant volume or concentration used: yes
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- Range-finding study: 1 animal
Main study: 2 animals - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation once daily and weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical sign and body weight - Statistics:
- No
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality
- Clinical signs:
- other: No treatment related clinical signs of toxicity and mortality were observed in both range finding study and main study animals
- Gross pathology:
- No treatment related gross pathological changes were observed in any of the animals in both range finding study and main study
Any other information on results incl. tables
TABLE 1. INDIVIDUAL ANIMAL CLINICAL SIGNS OF TOXICITY ANDMORTALITY RECORD
Phase of the Experiment
| Dose (mg/kg body weight) | Animal No. | Sex | Time of Application | Clinical Signs of Toxicity and Mortality on Day 1 | Clinical Signs of Toxicity and Mortality on days | |||||||||||||||||
20-30 mins | 1 hr (±10 mins) | 2 hrs (±10 mins) | 4 hrs (±10 mins) | 6 hrs (±10 mins) | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | |||||
Range Finding Study | 2000 | Rg6745 | F | 11:44 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Main Study | 2000 | Rg6746 | F | 11:45 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rg6747 | F | 11:46 | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
N: Normal; F: Female; mins: minutes; hr/hrs: hour/hours
TABLE 2. INDIVIDUAL ANIMAL SKIN REACTION SCORE RECORDD
Phase of the Experiment | Dose (mg/kg body weight) | Sex | Animal No. | Skin Reaction Observations | Skin Reaction Score on Days | ||
3 (24 hour) | 4 (48 hour) | 5 (72 hour) | |||||
Range Finding Study | 2000 | F | Rg6745 | ER | 0 | 0 | 0 |
ED | 0 | 0 | 0 | ||||
Main Study | 2000 | F | Rg6746 | ER | 0 | 0 | 0 |
ED | 0 | 0 | 0 | ||||
F | Rg6747 | ER | 0 | 0 | 0 | ||
ED | 0 | 0 | 0 |
F: Female; ER: Erythema; ED: Edema; 0: No erythema and no edem
TABLE 3.INDIVIDUAL ANIMAL BODY WEIGHT (g) AND PERCENT CHANGE IN BODY WEIGHT WITH RESPECT TO DAY 1
Phase of the Experiment | Dose (mg/kg body weight) | Animal No. | Sex | Quantity of test item applied (mg) | Body Weight (g) on Days | Percent Change in Body Weight with Respect to Day | ||||
1 | 8 | 15 | 1 to 8 | 1 to 15 | ||||||
Range Finding Study | 2000 | Rg6745 | F | 420.3 | 210.15 | 228.61 | 245.13 |
| 8.78 | 16.65 |
Main Study | 2000 | Rg6746 | F | 439.3 | 219.65 | 236.13 | 252.73 |
| 7.50 | 15.06 |
Rg6747 | F | 440.3 | 220.16 | 238.21 | 256.41 | 8.20 | 16.47 | |||
|
| Mean | 219.91 | 237.17 | 254.57 |
| 7.85 | 15.76 | ||
|
| ±SD | 0.36 | 1.47 | 2.60 |
| 0.49 | 0.99 | ||
|
| n | 2 | 2 | 2 |
| 2 | 2 |
F: Female; SD: Standard Deviation; n: Number of animals
Quantity of Test Item Applied (mg) | = | Dose / 1000 X Body weight (g) |
| = | 2000 / 1000 X 210.15 |
| = | 420.3 mg |
TABLE 4. INDIVIDUAL ANIMALGROSS PATHOLOGY FINDINGS
Phase of the Experiment | Dose (mg/kg body weight) | Animal No. | Sex | Fate | Gross Pathology Findings | |
External | Internal | |||||
Range finding Study | 2000 | Rg6745 | F | TS | NAD | NAD |
Main Study | 2000 | Rg6746 | F | TS | NAD | NAD |
Rg6747 | F | TS | NAD | NAD |
NAD: No Abnormality Detected; F: Female;TS: Terminal Sacrifice
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions employed and based on the above results, it is concluded that the acute dermal median lethal dose (LD50) of test item, Cyclic Glucamide C12-C14 in Sprague Dawley rats is >2000 mg/kg body weight.
- Executive summary:
The test item Cyclic Glucamide C12-C14 was evaluated for Acute Dermal Toxicity study in Sprague Dawley Rats.
The study was performed in two phases i.e. range finding study and main study. Range finding study was performed with one female rat and main study was performed with two female rats. On the day before the application of the test item, fur on the dorso-lateral area of the trunk of the animals was removed by clipping closely with an electric hair clipper and care was taken to avoid abrading the skin.
The required quantity of the test item was applied as uniform film over an area of approximately 10% of the total body surface. The test item was held on to the applied surface by covering with cotton gauze dressing and wrapped with non-irritating adhesive tape and finally the application site was wrapped using semi-occlusive crepe bandage. The contact period of test item was 24 hours. At the end of the contact period, the residual test item was washed using distilled water and dried with absorbent cotton.
The animals were dosed in a stepwise procedure with one female rat at a time in range finding study. Since the LD50of structure analogues is >2000 mg/kg body weight based on information provided by sponsor and as per the material safety data sheet provided by sponsor the LD50of test item is >2000 mg/kg body weight, a starting dose of 2000 mg/kg body weight was selected from the fixed dose levels of 50, 200, 1000 and 2000 mg/kg body weight. No clinical signs and mortalities were observed at the dose level of 2000 mg/kg body weight in range finding study. Hence, during main study, two animals were administered with the same dose level of 2000 mg/kg body weight. No clinical signs and mortalities were observed at the dose level of 2000 mg/kg body weight. Hence, no further testing was carried out.
All the animals were observed for clinical signs of toxicity and mortality at 20 to 30 min, 1 hr (±10 mins), 2 hrs (±10 mins), 4 hrs (±10 mins) and 6 hrs (±10 mins) post dosing on day 1 and thereafter once daily for clinical signs of toxicity and twice daily for mortality during the 14 days observation period. Skin reactions were scored at 24, 48 and 72 hours after patch removal using draize scoring system. The body weight was recorded at receipt, on day 1 before test item application and on days 8 and 15. At the end of observation period, all the animals were humanely sacrificed by carbon dioxide asphyxiation and subjected to necropsy and detailed gross pathological examination.
No mortality and clinical signs were noted.
No skin reactions were noted at 24, 48 and 72 hours after patch removal.
No treatment related changes in body weight and percent change in body weight with respect to day 1 were noted. Normal increase in body weights were noted during the observation period.
No treatment related gross pathological changes were noted at 2000 mg/kg body weight (range finding study and main study) during necropsy
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