Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 236-216-9 | CAS number: 13241-33-3
- 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:
- From November 15th to November 29th, 2016.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- (S)-7-[[2-O-6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,3-dihydro-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one
- EC Number:
- 236-216-9
- EC Name:
- (S)-7-[[2-O-6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,3-dihydro-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one
- Cas Number:
- 13241-33-3
- Molecular formula:
- C28H34O15
- IUPAC Name:
- (S)-7-[[2-O-6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,3-dihydro-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- (SPF Caw)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER LABS (53940 Le Genest St Isle – France)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: the males were 7 weeks old and the females 8 weeks old.
- Weight at study initiation: the mean weight of male rats was 267.6 g, and the mean weight of female rats 222.0 g
- Housing: during the treatment, animals were kept in individual cages. They were solid-bottomed clear polycarbonate cages with a stainless steel mesh lid, containing dust free weed shavings (changed at least 2 times per week).
- Diet (e.g. ad libitum): foodstuff (ENVIGO 2016) ad libitum.
- Water (e.g. ad libitum): tap-water from public distribution system ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- DMSO
- Details on dermal exposure:
- TEST SITE
- % coverage: at least 10%
- Type of wrap if used: non occlusive porous gauze dressing (50 mm x 50 mm non woven swab of 4-layer patch from MEDISTOCK) secured in position with a strip of surgical adhesive tape (50 mm wides hypoallergenic microporeTM adhesive tape from 3M)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsing with distilled water.
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 0.2 g/mL
- Constant volume or concentration used: yes
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit): 10 ml/kg bw. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes
- Remarks:
- historical control.
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Systematic examinations were carried out daily to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item. The animals were weighed on day 0 (just before administering the test item) then on day 2, day 7, and day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology (only if organs presenting abnormalities).
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study.
- Clinical signs:
- other: No systemic clinical signs related to the administration of the test item were observed.
- Gross pathology:
- The macroscopic examinations of the animals at the end of the study did not reveal treatment-related changes.
- Other findings:
- - Other observations: Erythema was noted in all animals (10/10) at 24 hours post dose. This reaction was totally reversible at day 3. Dryness of the skin was noted in females at day 2 and in all animals at day 3. The skin recovered a normal aspect on day 4. A yellow coloration was noted in all animals at 24 hours post-dose.
Any other information on results incl. tables
Table 1. Body weight evolution
Males |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
Rm 0689 |
266 |
268 |
2 |
317 |
51 |
401 |
135 |
Rm 0690 |
271 |
273 |
2 |
317 |
46 |
381 |
110 |
Rm 0691 |
271 |
271 |
0 |
327 |
56 |
379 |
108 |
Rm 0692 |
258 |
265 |
7 |
315 |
57 |
384 |
126 |
Rm 0693 |
272 |
276 |
4 |
333 |
61 |
379 |
107 |
Mean |
267.6 |
270.6 |
3.0 |
321.8 |
54.2 |
384.8 |
117.2 |
SD |
5.9 |
4.3 |
2.6 |
7.8 |
5.8 |
9.3 |
12.6 |
Females |
|||||||
Rm 0694 |
217 |
213 |
-4 |
242 |
25 |
259 |
42 |
Rm 0695 |
229 |
224 |
-5 |
258 |
29 |
274 |
45 |
Rm 0696 |
226 |
222 |
-4 |
253 |
27 |
270 |
44 |
Rm 0697 |
222 |
221 |
-1 |
247 |
25 |
279 |
57 |
Rm 0698 |
216 |
213 |
-3 |
239 |
23 |
283 |
67 |
Mean |
222.0 |
218.6 |
-3.4 |
247.8 |
25.8 |
273.0 |
51.0 |
SD |
5.6 |
5.2 |
1.5 |
7.8 |
2.3 |
9.2 |
10.7 |
Table 2. Necropsy data sheet.
Observations |
Males Rm0689 to Rm0693 |
Females Rf0694 to Rf0698 |
General appearance |
Normal |
Normal |
Oesophagus |
NTR |
NTR |
Stomach |
NTR |
NTR |
Duodenum |
NTR |
NTR |
Jejunum |
NTR |
NTR |
Ileon |
NTR |
NTR |
Caecum |
NTR |
NTR |
Colon |
NTR |
NTR |
Rectum |
NTR |
NTR |
Spleen |
NTR |
NTR |
Liver |
NTR |
NTR |
Thymus |
NTR |
NTR |
Trachea |
NTR |
NTR |
Lungs |
NTR |
NTR |
Heart |
NTR |
NTR |
Kidneys |
NTR |
NTR |
Urinary bladder |
NTR |
NTR |
Ovaries |
- |
NTR |
Uterus |
- |
NTR |
Testicles |
NTR |
- |
Treatment area (skin) |
NTR |
NTR |
Adrenals |
NTR |
NTR |
Pancreas |
NTR |
NTR |
Particulars |
None |
none |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU criteria.
- Conclusions:
- The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rats.
- Executive summary:
The acute dermal toxicity of the test item was studied according to OECD 402 (GLP study). A limit test was performed by dermal administration of the test item at a dose of 2000 mg/kg bw to 5 male and 5 female Wistar (SPF:Caw) rats. After 24 h of exposure, the area was rinsed with water, and the animals were observed daily for 14 days. Observations included clinical signs, mortality, body weights, gross pathology and, if any abnormality was observed, histopathology of the affected tissues. No mortality or systemic clinical signs related to the administration of the test item were observed throughout the study. Erythema was noted in all animals (10/10) at 24 hours post dose. This reaction was totally reversible at day 3. Based on the results of the study, the test item was found to be non toxic, with an LD50 > 2000 mg/kg bw.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.