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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
Endpoint summary
Administrative data
Description of key information
Dimethyl sebacate was found to be of low toxicity in an acute and dermal toxicity tests performed according to OECD 401 and OECD 402 guidelines,
respectively.
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:
- 24 October 2012 to 05 April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant and in accordance with current test guidelines
- 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 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: HsdHan:WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester
- Age at study initiation: 8 to 9 weeks of age
- Weight at study initiation: 168 to 187g
- Fasting period before study: from the evening of the day prior to dosing (Day -1) until approximately 3 hours after dosing
- Housing: housed in groups of up to five during the acclimatisation period in cages that conform to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989). From the day prior to dosing (Day –1), the rats were housed in groups of three in similar cages.
- 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 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 45 to 65%
- 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: 5 November 2012 To: 22 November 2012 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Not applicalbe
- Amount of vehicle (if gavage): Not applicalbe
- Justification for choice of vehicle: Not applicalbe
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
MAXIMUM DOSE VOLUME APPLIED: 2 mL/kg
DOSAGE PREPARATION (if unusual): The test article was warmed to approximately 30ºC until it was in liquid form and dosed without dilution. The liquid test article was shaken immediately prior to use to ensure homogeneity.
- Rationale for the selection of the starting dose: Since there were no data to indicate that deaths may occur at dose levels of less than 2000 mg/kg, the first dose level was 2000 mg/kg. - Doses:
- A dose level of 2000 mg/kg with a specific gravity of 1.003 g/mL and a dose volume of 2 mL/kg
- No. of animals per sex per dose:
- 3 animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Rats were weighed on Day -1 (day before dosing) and on Days 1, 4, 8 and 15. Treated rats were observed closely for clinical signs of reaction to treatment. Clinical signs were recorded 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.
- Necropsy of survivors performed: yes - Statistics:
- Not required
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No clinical signs were seen.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The acute median lethal oral dose level of the test article, Dimethyl Sebacate, was found to exceed 2000 mg/kg.
The test material was considered to have no significant acute toxic risk in respect of its acute oral 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 assess the acute toxicity of the test article, Dimethyl Sebacate, following a single oral administration to small groups of rats. The study design provides information for hazard assessment and classification and enables a chemical to be assigned to toxicity classes but severely restricts animal usage.
Groups of three female fasted rats were given the test article as a single dose on Day 1 by oral gavage at a dose level of 2000 mg/kg. All animals were killed on Day 15 and subsequently underwent a full necropsy.
There were no deaths and no clinical signs of reaction to treatment.
All rats achieved body weight gains over the study period.
No abnormalities were noted at necropsy.
The acute median lethal oral dose level of the test article, Dimethyl Sebacate, was found to exceed 2000 mg/kg.
The test material was considered to have no significant acute toxic risk in respect of its acute oral toxicity and did not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Reference
Table 1 Mortality data
Dose level (mg/kg) |
Mortality ratio |
2000 |
0/6 |
Table 2 Clinical signs following treatment
Dose level: 2000 mg/kg
Clinical sign |
Animal number |
||||||||||||
118 |
119 |
120 |
121 |
122 |
123 |
||||||||
No observations |
ü |
ü |
ü |
ü |
ü |
ü |
Key:
ü No clinical signs seen throughout the observation period
Table 3 Individual body weights and weekly increments
Dose level (mg/kg) |
Animal number |
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 |
118 |
168 |
159 |
175 |
177 |
183 |
18 |
6 |
119 |
176 |
163 |
178 |
182 |
190 |
19 |
8 |
|
120 |
187 |
181 |
195 |
200 |
207 |
19 |
7 |
|
2000 |
121 |
177 |
169 |
180 |
189 |
185 |
20 |
-4 |
122 |
173 |
163 |
176 |
184 |
191 |
21 |
7 |
|
123 |
176 |
168 |
178 |
172 |
185 |
4 |
13 |
A minus symbol [-] indicates a body weight loss
Table 4 Necropsy findings
Dose level: 2000 mg/kg
Animal number |
Time and manner of death (Day) |
Necropsy comments |
118 |
15T |
No macroscopic changes
|
119 |
15T |
No macroscopic changes
|
120 |
15T |
No macroscopic changes
|
121 |
15T |
No macroscopic changes
|
122 |
15T |
No macroscopic changes
|
123 |
15T |
No macroscopic changes
|
T Animal killed by isofluoranean aesthesia followed by exsanguinations at completion of observation period
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
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:
- 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
- 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
- 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 - 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
- Preliminary study:
- No compound related mortality occurred in the preliminary test.
- 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.
- 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).
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral toxicity sudy (Dreher, 2013)
This GLP study performed according to OECD guideline was conducted to assess the acute toxicity of the test article, Dimethyl Sebacate, following a single oral administration to small groups of rats. The study design provides information for hazard assessment and classification and enables a chemical to be assigned to toxicity classes but severely restricts animal usage. Groups of three female fasted rats were given the test article as a single dose on Day 1 by oral gavage at a dose level of 2000 mg/kg. All animals were killed on Day 15 and subsequently underwent a full necropsy. There were no deaths and no clinical signs of reaction to treatment. All rats achieved body weight gains over the study period. No abnormalities were noted at necropsy. The acute median lethal oral dose level of the test article, Dimethyl Sebacate, was found to exceed 2000 mg/kg.
The test material was considered to have no significant acute toxic risk in respect of its acute oral toxicity and did not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Acute dermal toxicity study (Dreher, 2013)
This GLP study performed according to OECD guideline 402 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).
Justification for selection of acute toxicity – oral endpoint
The study was GLP and performed according to OECD guideline. No mortality or severe clinical signs were recorded.
Justification for selection of acute toxicity – dermal endpoint
The study was fully compliant and performed accroding to OECD guideline. There were no mortality or severse clinical signs.
Justification for classification or non-classification
No classification is warranted for oral and dermal acute toxicity under EU Dangerous Substances Directive 67/548/EEC or CLP EU Regulation 1272/2008.
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