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EC number: 203-431-4 | CAS number: 106-79-6
- 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:
- 23 October 2012 to DATE
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant and in accordance with current guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
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
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Dimethyl sebacate
- EC Number:
- 203-431-4
- EC Name:
- Dimethyl sebacate
- Cas Number:
- 106-79-6
- Molecular formula:
- C12H22O4
- IUPAC Name:
- 1,10-dimethyl decanedioate
- Test material form:
- other: Solid to liquid (melting point 23°C)
- Details on test material:
- Name: Dimethyl sebacate
CAS number: 106-79-6
Batch number: 120801
Purity: 99.08%
Expiry date: 31 August 2013
Receipt date: 11 October 2012
Storage: stored in a sealed container, at 15 to 25ºC, in the dark.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 279 to 312 g (males) and 179 to 206 g (females)
- Housing: cages that conformed to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989)
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1, ad libitum
- Water (e.g. ad libitum): Mains water was provided, ad libitum
- Acclimation period: 7 to 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 32 to 66%
- Air changes (per hr): 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): The rooms were illuminated by fluorescent strip-lights for twelve hours daily.
IN-LIFE DATES: From: 20 November 2012 To: 12 December 2012
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsum
- % coverage: 10%
- Type of wrap if used: A dense gauze patch held in place with elasticated; open weave adhesive compression bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dermal test site of each rat was lightly brushed clean of any solid residues and swabbed with water-moistened cotton wool
- Time after start of exposure: 24 Hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg
- Concentration (if solution): Not Applicable
- Constant volume or concentration used: yes
- For solids, paste formed: Not applicable - Duration of exposure:
- 15 Days
- Doses:
- One dose at 2000 mg/kg
- No. of animals per sex per dose:
- Five male and five female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations were undertaken immediately post dose, at approximately 15 and 30 minutes post dose, hourly between 1 and 4 hours post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period. Rats were weighed on Day -1 (day before dosing) and on Days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- No compound related mortality occurred in the preliminary test.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: Discriminating dose
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no clinical signs of reaction to treatment.
- Gross pathology:
- No macroscopic changes were noted at necropsy.
Any other information on results incl. tables
Table 1 Mortality data
Dose level (mg/kg) |
Mortality ratio |
|
Male |
Female |
|
2000
|
0/5
|
0/5
|
Table 2 Clinical signs following treatment
Dose level: 2000 mg/kg
Clinical sign |
Animal number and sex |
||||
174M |
175M |
176M |
177M |
178M |
|
No observations |
ü |
ü |
ü |
ü |
ü |
Clinical sign |
Animal number and sex |
||||
179F |
180F |
181F |
182F |
183F |
|
No observations |
ü |
ü |
ü |
ü |
ü |
Key:
ü No clinical signs seen throughout the observation period
Table 3 Dermal reactions
Dose level: 2000 mg/kg
Day |
Dermal reaction |
Animal number and sex |
||||
174M |
175M |
176M |
177M |
178M |
||
2 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
3 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
4 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
5 to 15 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Day |
Dermal reaction |
Animal number and sex |
||||
179F |
180F |
181F |
182F |
183F |
||
2 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
3 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
4 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
5 to 15 |
Erythema Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
Key:
- No other dermal changes apparent
Table 4 Individual body weights and weekly increments
Dose level (mg/kg) |
Animal number and sex |
Body weight (g) at: |
Increment (g) |
|||||
Day -1 |
Day 1 |
Day 4 |
Day 8 |
Day 15 |
Day 1 to 8 |
Day 8 to 15 |
||
2000 |
174M |
276 |
287 |
282 |
290 |
322 |
3 |
32 |
175M |
313 |
310 |
316 |
330 |
343 |
20 |
13 |
|
176M |
299 |
299 |
305 |
318 |
333 |
19 |
15 |
|
177M |
277 |
279 |
284 |
290 |
309 |
11 |
19 |
|
178M |
312 |
312 |
319 |
330 |
353 |
18 |
23 |
|
2000 |
179F |
177 |
180 |
175 |
178 |
195 |
-2 |
17 |
180F |
187 |
179 |
182 |
197 |
204 |
18 |
7 |
|
181F |
209 |
206 |
211 |
220 |
227 |
14 |
7 |
|
182F |
190 |
194 |
199 |
199 |
204 |
5 |
5 |
|
183F |
194 |
192 |
197 |
194 |
194 |
2 |
0 |
A minus symbol [-] indicates a body weight loss
Table 5 Necropsy findings
Dose level: 2000 mg/kg
Animal number and sex |
Time and manner of death (Day) |
Necropsy comments |
174M |
15T |
No macroscopic changes
|
175M |
15T |
No macroscopic changes
|
176M |
15T |
No macroscopic changes
|
177M |
15T |
No macroscopic changes
|
178M |
15T |
No macroscopic changes
|
179F |
15T |
No macroscopic changes
|
180F |
15T |
No macroscopic changes
|
181F |
15T |
No macroscopic changes
|
182F |
15T |
No macroscopic changes
|
183F |
15T |
No macroscopic changes
|
T Animal killed by isofluorane anaesthesia followed by exsanguination at completion of observation period
Applicant's summary and conclusion
- Interpretation of results:
- other: No significant acute toxicity
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The acute median lethal dermal dose of Dimethyl Sebacate to rats was found to exceed 2000 mg/kg.
The test material was considered to have no significant acute toxic risk in respect of its acute dermal toxicity and did not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). - Executive summary:
This study was conducted to determine the acute dermal toxicity of the test article, Dimethyl Sebacate following a single (24 hour) semi-occluded topical application to the rat. The test article was applied as an undiluted liquid to the clipped dorsum of a group of five male and five female rats on Day 1. Each rat received a single topical application at a dose level of 2000 mg/kg. The treated areas of dorsum were covered by a semi-occlusive dressing for 24 hours. All animals were killed on Day 15 and subsequently underwent a full necropsy. There were no deaths, no clinical signs of reaction to treatment and no overt dermal changes were noted at the test sites. All animals showed gains in body weight over the study period. No macroscopic changes were apparent at necropsy. The acute median lethal dermal dose of Dimethyl Sebacate to rats was found to exceed 2000 mg/kg. The test material was considered to have no significant acute toxic risk in respect of its acute dermal toxicity and did not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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