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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-117-2 | CAS number: 10039-33-5
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- June 13th to July 4th, 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Reliability of original study is 1
- Justification for type of information:
- Justification for Read Across is given in Section 13 of IUCLID.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Due to a technical error, the day 3 clinical observations for two females were not recorded. This deviation was considered not to affect the integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- Due to a technical error, the day 3 clinical observations for two females were not recorded. This deviation was considered not to affect the integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- EC Number:
- 268-500-3
- EC Name:
- Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- Cas Number:
- 68109-88-6
- Molecular formula:
- C28H48O8Sn
- IUPAC Name:
- Ethyl-9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan:WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon., UK
- Age at study initiation: 8 - 12 weeks.
- Weight at study initiation: at least 200 g.
- Housing: animals were housed individually during the 24 hour exposure period and in groups of up to 4, by sex, for the remainder of the study in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: rodent diet (2014C Teklad Global Rodent diet, supplied by Harlan Laboratories UK Ltd., Oxon., UK), ad libitum.
- Water: mains water, ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C.
- Humidity: 30 - 70 %.
- Air changes: at least 15 changes per hour.
- Photoperiod: 12 hrs dark / 12 hrs light.
IN-LIFE DATES: from 13 June 2012 to 4 July 2012.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- Preparation for exposure: on the day before treatment the back and flanks of each animal were clipped free of hair.
- % coverage: approximately 10 % of the total body surface area.
- Type of wrap if used: a piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE: after the 24 hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test material
TEST MATERIAL: the appropriate amount of test material was moistened with arachis oil BP and applied as evenly as possible to the area of shorn skin - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- In the absence of data suggesting the test material was toxic, one male and one female rat were initially treated with the test material at a dose level of 2000 mg/kg bodyweight. As no mortalities were noted, a further group of 4 male and 4 female animals were similarly treated at a dose level of 2000 mg/kg bodyweight to bring the total of each sex to 5.
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: animals were observed for deaths and overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and once daily thereafter. The test site was observed daily for evidence of primary irritation and scored according to Draize. Individual bodyweights were recorded prior to application of the test material on day 0 and on days 7 and 14.
- Necropsy of survivors performed: yes. Animals were killed by cervical dislocation. All animals were subjected to gross necropsy, consisting of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- No signs of systemic toxicity were noted during the study.
- Body weight:
- One female showed bodyweight loss during the first week but expected gain in bodyweight during the second week and one female showed expected gain in bodyweight during the first week but bodyweight loss during the second week. Remaining animals showed expected gains in bodyweight over the study period.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Signs of dermal irritation noted were very slight erythema, crust formation and desquamation. There were no signs of dermal irritation noted at the test site of one male.
Any other information on results incl. tables
Table: individual dermal reactions
Animal no. and sex |
Observation |
Effects noted after initiation of exposure (days) |
|||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 -0 M |
Erythema |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other |
0 |
0 |
0 |
0 |
D |
D |
D |
Cf |
Cf |
Cf |
Cf |
D |
D |
0 |
|
3 -0 M |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 -1 M |
Erythema |
1 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other |
0 |
0 |
0 |
0 |
D |
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 -2 M |
Erythema |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 -3 M |
Erythema |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other |
0 |
0 |
0 |
0 |
D |
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 -0 F |
Erythema |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 -0 F |
Erythema |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other |
0 |
0 |
0 |
0 |
D |
D |
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 -1 F |
Erythema |
1 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other |
0 |
0 |
0 |
0 |
D |
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 -2 F |
Erythema |
1 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other |
0 |
0 |
0 |
0 |
D |
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 -3 F |
Erythema |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other |
0 |
0 |
0 |
0 |
D |
D |
D |
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 = no reactions
D = desquamation
Cf = crust formation
Table: Individual Bodyweights and Weekly Bodyweight Changes
Animal no. and sex |
Bodyweight (g) at day |
Bodyweight change (g) during week |
|||
0 |
7 |
14 |
1 |
2 |
|
1 -0 M |
350 |
361 |
376 |
11 |
15 |
3 -0 M |
260 |
285 |
299 |
25 |
14 |
3 -1 M |
255 |
276 |
299 |
21 |
23 |
3 -2 M |
244 |
275 |
308 |
31 |
33 |
3 -3 M |
234 |
256 |
289 |
22 |
33 |
2 -0 F |
230 |
227 |
237 |
-3 |
10 |
4 -0 F |
217 |
220 |
224 |
3 |
4 |
4 -1 F |
200 |
210 |
218 |
10 |
8 |
4 -2 F |
214 |
223 |
221 |
9 |
-2 |
4 -3 F |
206 |
213 |
218 |
7 |
5 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as harmful/toxic according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
The acute dermal toxicity of the test material was investigated in accordance with the standardised guidelines OECD 402 and EU Method B.3. During the study, a group of ten animals (five males and five females) was given a single 24 hour, semi-occluded dermal application of the test material to intact skin clipped free of hair at a dose level of 2000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
During the study there were no deaths and no signs of systemic toxicity were observed. One female showed bodyweight loss during the first week but expected gain in bodyweight during the second week and one female showed expected gain in bodyweight during the first week but bodyweight loss during the second week. Remaining animals showed expected gains in bodyweight over the study period. Signs of dermal irritation noted were very slight erythema, crust formation and desquamation. There were no signs of dermal irritation noted at the test site of one male. No abnormalities were noted at necropsy.
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.