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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
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- Nanomaterial pour density
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- 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
Oral: LD50cut-off (rat, females): 5000 mg/ kg bw
Dermal: LD50 (rat, females)>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
- Study period:
- 2021-04-22 to 2021-07-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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)
- Test type:
- acute toxic class method
- Limit test:
- no
- Specific details on test material used for the study:
- Name: cyclic Glucamide C12-C14
Product
(Common Name/Code): cyclic N-dodecanoyl/tetradecanoyl-N-methylglucamine / cyclic Glucamide C12-C14
Lot No.: S148866
Storage Conditions: room temperature
Physical State at Room
Temperature: slightly turbid solid mass
Color: brown
Density: 1.07 g/cm³
Molecular Weight: main compounds: 359,5 g/mol (C12-derivative); 387,5 g/mol (C14-derivative)
pH at at Room
Temperature: approx. 6-8 (not tested)
Date of Analysis: 30 September 2020
Expiry Date: 30 September 2022
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety. - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test System
Species/strain: WISTAR rats Crl: WI(Han)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: Female (non-pregnant and nulliparous)
Number of animals: 3 per step
Age at the
beginning of the study: 8 – 10 weeks
Body weight on the
day of administration:Step 1: 162 – 168 g;
Step 2: 178 – 186 g
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to the German Act on Animal Welfare [8] the animals were bred for experimental purposes.
This study was performed in an AAALAC-accredited laboratory. According to German animal protection law, the study type has been reviewed and accepted by local authorities. Furthermore, the study has been subjected to Ethical Review Process and was authorised by the Bavarian animal welfare administration.
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
- 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
- Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich Product Testing Munich GmbH
- Adequate acclimatisation period (at least five days) under laboratory conditions - Route of administration:
- oral: gavage
- Vehicle:
- other: Aqua ad injectionem (sterile water, Deltamedica, lot no. 2005066, expiry date: 04/2023). This vehicle was chosen due to its non-toxic characteristics.
- Details on oral exposure:
- Preparation of the Animals
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 3 hours post dosing.
Administration
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.
Volume of Test Item Preparation Applied per Animal
Animal No. / Sex Dose (mg/kg bw) Body Weight on Day of Administration (g) Volume of Test Item Preparation in Vehicle
Administered per Animal (mL)
1 / Female 2000 162 1.6
2 / Female 168 1.7
3 / Female 165 1.7
4 / Female 2000 178 1.8
5 / Female 183 1.8
6 / Female 186 1.9 - Doses:
- The starting dose was selected to be 2000 mg/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:
- Observation Period
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). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
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 at a dosage of 400-800 mg/kg bw.
All animals were subjected to gross necropsy and examined macroscopically for gross pathological changes. In the absence of gross pathological changes no tissues were preserved for a possible histopathological evaluation.
Evaluation of Results
Results were interpreted according to OECD Guideline 423, Annex 2 and GHS.
Individual reactions of each animal were recorded at each time of observation.
Toxic response data were recorded by dose level.
Nature, severity and duration of clinical observations were described.
The body weight changes were summarised in a tabular form.
Necropsy findings were described. - Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived until the end of the study showing slight signs of toxicity.
- Clinical signs:
- other: The most relevant clinical findings in the animals were reduced spontaneous activity, hunched posture, piloerection, prone position, half eyelid closure and eyes closed. All animals recovered within up to 3 days post-dose.
- Gross pathology:
- At necropsy, no macroscopic findings were observed in any animal of any step.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, a single oral application of the test item Cyclic Glucamide C12-C14 to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but no mortality.
The median lethal dose of Cyclic Glucamide C12-C14 after a single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): 5000 mg/ kg bw - Executive summary:
Summary Results
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight.On the sponsors request and based on the outcome of the solubility test, the test item was dissolved in the vehicle aqua ad injectionem (sterile water) at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.
All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15.All animals were necropsied and examined macroscopically.
Table1: Resultsper Step
Step
Sex / No.
Starting Dose (mg/kg bw)
Number of Animals
Number of Intercurrent Deaths
1
Female / 1 - 3
2000
3
0
2
Female / 4 - 6
2000
3
0
All animals survived until the end of the study showing slight signs of toxicity.
The most relevant clinical findings in the animals were reduced spontaneous activity, hunched posture, piloerection, prone position, half eyelid closure and eyes closed. All animals recovered within up to 3 days post-dose.
Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain.
At necropsy, no macroscopic findings were observed in any animal of any step.
LD50cut-off (rat): 5000 mg/kg bw
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle: aqua ad injectionem (sterile water)
Number of animals: 3 per step / 2 steps performed
Method: OECD 423, EC 440/2008, Method B.1 tris, OPPTS 870.1100
Conclusion
Under the conditions of the present study, a single oral application of the test item Cyclic Glucamide C12-C14 to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but no mortality.
The median lethal dose of Cyclic Glucamide C12-C14 after a single oral administration to female rats, observed over a period of 14 days is:
LD50cut-off (rat): 5000 mg/ kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Guideline Study under GLP; high quality
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
- Study period:
- 17 February 2022 to 11 March 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- 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 - 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 - 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
- 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
- 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
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Guideline Study under GLP; high quality
Additional information
Justification for classification or non-classification
Based on the results from available guideline studies which revealed no adverse effects, the registration substance is not subject to labelling and classification requirements.
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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