Registration Dossier
Registration Dossier
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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.
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REACH
nonapotassium 2,4,6-trihydroxy-4-methyl-3,5-dioxa-2,4,6-trisilaheptane-2,6-bis(olate) 2,6,8-trihydroxy-4,6-dimethyl-3,5,7-trioxa-2,4,6,8-tetrasilanonane-2,4,8-tris(olate) 6-hydroxy-2,4,6-trimethyl-1,3,5,2,4,6-trioxatrisilinane-2,4-bis(olate) dihydroxy(methyl)silanolate {[dihydroxy(methyl)silyl]oxy}(hydroxy)methylsilanolate
EC number: 935-877-7 | CAS number: -
Toxicological information
Skin irritation / corrosion
Currently viewing:
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 14-29, 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- further data not available
- EC Number:
- 935-877-7
- Cas Number:
- 31795-24-1
- IUPAC Name:
- further data not available
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: solid
- Colour: colourless
- Storage condition of test material: dry, at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 23 weeks old
- Weight at study initiation: >2 kg
- Housing: semi-barrier in an air-conditioned room, ABS-plastic rabbit cages, floor 4200 cm²
- Diet (e.g. ad libitum): free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits
- Water (e.g. ad libitum): free access to tap water
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): artificial light, sequence being 12 hours light, 12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A dose of 0.5 g of the test item was applied to each test site.
- Duration of treatment / exposure:
- The test item was held in contact with the skin throughout a 4-hour period.
At the end of the exposure period, the residual test item was removed with tap water. - Observation period:
- All animals were observed for 72 hours after the patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: The gauze was held in place with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the residual test item was removed with tap water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
- Erythema and Eschar Formation
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well defined erythema
3: Moderate to severe erythema
4: Severe erythema (beef redness) to eschar formation preventing grading of erythema
- Oedema Formation
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well defined by definite raising)
3: Moderate oedema (raised approximately 1 mm)
4: Severe oedema (raised more than 1 mm and extending beyond exposure area)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals #1-3
- Time point:
- other: mean 24-72 hours
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals #1-3
- Time point:
- other: mean 24-72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No irritant or corrosive effects were observed on the intact skin of the three female rabbits (strain NZW) after a contact time of 4 hours.
In animal no 3 the test item showed slightly irritant (erythema grade 1) effects 48 hours after patch removal which were fully reversible within 72 hours. - Other effects:
- Neither mortalities nor significant clinical signs of toxicity were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, the single dermal application of the test item at a dose of 0.5 g showed slightly irritant but no corrosive
effects which were fully reversible within 72 hours after patch removal in one out of three animals. Neither irritant nor corrosive effects were observed in any other animal. Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC, the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.
According to Annex I of Regulation (EC) 1272/2008, the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.
According to GHS (Globally Harmonized Classification System), the test item has no obligatory labelling requirement for skin irritation.
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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