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EC number: 230-072-0 | CAS number: 6938-94-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from experimental study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The objective of the study was to assess the dermal toxicity of test chemical after single dose application by dermal route in rats.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Diisopropyl adipate
- EC Number:
- 230-072-0
- EC Name:
- Diisopropyl adipate
- Cas Number:
- 6938-94-9
- Molecular formula:
- C12H22O4
- IUPAC Name:
- 1,6-bis(propan-2-yl) hexanedioate
- Test material form:
- liquid
- Details on test material:
- SOURCE OF TEST MATERIAL
- Identification: Di isopropyl adipate (CAS No. - 6938-94-9)
- Source of test material: Sustainability Support Services (Europe) AB
- Appearance: Colourless Liquid
- Batch No.of test material: Lot 1/05
- Manufactured date: Not provided
- Expiration date of the lot/batch: Not provided
- Purity: 99.55%
RADIOLABELLING INFORMATION (not applicable)
- Radiochemical purity: N/A
- Specific activity: N/A
- Locations of the label: N/A
- Expiration date of radiochemical substance: N/A
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored in cool place. Kept container tightly closed in a dry and well- ventilated place.
- Stability under test conditions: No data available
- Solubility and stability of the test substance in the solvent/vehicle: No data available
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data available
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No data available
- Preliminary purification step (if any): No data available
- Final dilution of a dissolved solid, stock liquid or gel: No data available
- Final preparation of a solid: No data available
FORM AS APPLIED IN THE TEST (if different from that of starting material): No data available
OTHER SPECIFICS:
- Safety precautions: Avoided contact with skin and eyes. Avoided inhalation of vapour or mist. Normal measures for preventive fire protection were taken. Aprons, caps, mask, gloves and goggles were used to ensure the health and safety of the personnel.
- Disposal: The remaining unused test item was disposed as per internal SOPs of sa-FORD and the same was documented in the raw data.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-House Bred at sa-Ford, Animal Facility
- Health Status : Healthy young adult animals were used for the study.
- Females were nulliparous and non-pregnant: yes
- Age at study initiation: No data available
- Weight at study initiation: Male: Minimum: 234 g and Maximum: 258 g Female: Minimum: 228 g and Maximum: 246 g
- Fasting period before study: No data available
- Housing: The animals were housed individually in polycarbonate cages.
- Bedding: All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) Batch No.: SPAR – 24/2013
- Room Sanitation: The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle: All the cages and water bottles were changed at least twice every week.
- Diet (e.g. ad libitum): All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No. 400012.
- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period: All animals were acclimatized to the test conditions for 5 days prior to administration of the test item.
- Identification: During Acclimatization, animals were temporarily marked by permanent marker, on their tails. After acclimatization, the animals were marked by toe pad micro tattooing and cage cards. Individual cage cards were labelled with project /Study No., species, strain, sex, animal ID. and No. of animal per cage, experiment start and end date.
- Randomization: Animals were selected manually. No computer generated randomization program was used.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Minimum: 20.40 °C Maximum: 23.10 °C
- Humidity (%): Minimum: 38.40% Maximum: 56.00%
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12
IN-LIFE DATES: From: February 10, 2014 To: March 01, 2014
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: Approximately 10% body surface area
- Type of wrap if used: Porous gauze dressing and non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test item was removed by using distilled water.
- Time after start of exposure: 24 hour
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight.
- Concentration (if solution): No data available
- Constant volume or concentration used: yes
- For solids, paste formed: no (The substance is liquid) - Duration of exposure:
- 24-hour
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 10 (Five per sex)
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical Observation
After test item administration, individual animals were frequently observed at 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period.
Mortality
Animals were observed twice daily for any mortality during the experimental period.
Body weight
All rats were weighed on days 0 (prior to dosing), 7 and 14.
Local Signs/Skin Reactions
All animals were observed once daily during days 1-14 (in common with clinical signs).
Pathology
At the end of 14 day observation period, all the surviving rats were euthanised by overdose of CO2 and subjected to gross pathology examination, for external and internal observations. - Statistics:
- No statistical analysis was performed since the study was terminated with limit test.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- No mortality observed
- Mortality:
- No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period.
- Clinical signs:
- other: No systemic or local signs of toxicity were observed at limit dose of 2000 mg/kg body weight of test item during the experimental period, except female animal nos. 8 and 10 were observed with erythema from day 2 to 8 and scab from day 9 to 12.
- Gross pathology:
- The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.
- Other findings:
- No data available
Any other information on results incl. tables
Table 1: Individual Animal Body Weight (g) and Body Weight Changes(%)
Dose:2000 mg/ kg bodyweight Density:0.9464
Animal No. |
Sex |
Dose (ml) Applied* |
Body Weight (gram) |
Body Weight Change (%) |
|||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
|||
1 |
Male |
0.52 |
247 |
245 |
265 |
-0.81 |
7.29 |
2 |
0.49 |
234 |
215 |
243 |
-8.12 |
3.85 |
|
3 |
0.52 |
245 |
240 |
256 |
-2.04 |
4.49 |
|
4 |
0.55 |
258 |
250 |
261 |
-3.10 |
1.16 |
|
5 |
0.52 |
244 |
238 |
264 |
-2.46 |
8.20 |
|
6 |
Female |
0.52 |
244 |
242 |
251 |
-0.82 |
2.87 |
7 |
0.52 |
246 |
246 |
249 |
0.00 |
1.22 |
|
8 |
0.49 |
231 |
235 |
231 |
1.73 |
0.00 |
|
9 |
0.48 |
228 |
229 |
226 |
0.44 |
-0.88 |
|
10 |
0.52 |
246 |
250 |
254 |
1.63 |
3.25 |
Key:* = Based on density of test item and day 0 body weight taken prior to dose application.
Table 2: Individual Animal Clinical Signs and Symptoms
Dose:2000 mg/kg body weight
Animal No. |
Sex |
Hour(s) - Day 0 |
Day |
||||||||||||||||
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
Male |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
Female |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
8 |
1 |
1 |
1 |
1 |
1 |
65+ |
65+ |
65+ |
65+ |
65+ |
65+ |
65+ |
146 |
146 |
146 |
146 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
1 |
65+ |
65+ |
65+ |
65+ |
65+ |
65+ |
65+ |
146 |
146 |
146 |
146 |
1 |
1 |
Key: 1 = Normal, 65 = Erythema, 146 = Scab, + = Mild
Table 3: Individual Animal Mortality Record
Dose:2000 mg/kg body weight
Animal No. |
Sex |
Days of Observation (0 to 14) |
|
Morning Observations |
Evening Observations |
||
1 |
Male |
No mortality and morbidity |
No mortality and morbidity |
2 |
No mortality and morbidity |
No mortality and morbidity |
|
3 |
No mortality and morbidity |
No mortality and morbidity |
|
4 |
No mortality and morbidity |
No mortality and morbidity |
|
5 |
No mortality and morbidity |
No mortality and morbidity |
|
6 |
Female |
No mortality and morbidity |
No mortality and morbidity |
7 |
No mortality and morbidity |
No mortality and morbidity |
|
8 |
No mortality and morbidity |
No mortality and morbidity |
|
9 |
No mortality and morbidity |
No mortality and morbidity |
|
10 |
No mortality and morbidity |
No mortality and morbidity |
Table 4:Summaryof Animal Body Weight (g) and Body Weight Changes (%)
Dose:2000 mg/kg body weight
Sex |
Body Weight (gram) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
||
Male |
Mean |
245.60 |
237.60 |
257.80 |
-3.31 |
5.00 |
SD |
8.56 |
13.46 |
8.98 |
2.82 |
2.82 |
|
n |
5 |
5 |
5 |
5 |
5 |
|
Female |
Mean |
239.00 |
240.40 |
242.20 |
0.60 |
1.29 |
SD |
8.77 |
8.44 |
12.76 |
1.09 |
1.78 |
|
n |
5 |
5 |
5 |
5 |
5 |
Keys:SD= Standard deviation, n = Number of animals
Table 5: GrossNecropsyObservation
Dose:2000 mg/kg body weight Mode of Death:Terminal Sacrifice
Animal No. |
Sex |
Gross Observation |
|
External |
Internal |
||
1 |
Male |
No abnormalities detected |
No abnormalities detected |
2 |
No abnormalities detected |
No abnormalities detected |
|
3 |
No abnormalities detected |
No abnormalities detected |
|
4 |
No abnormalities detected |
No abnormalities detected |
|
5 |
No abnormalities detected |
No abnormalities detected |
|
6 |
Female |
No abnormalities detected |
No abnormalities detected |
7 |
No abnormalities detected |
No abnormalities detected |
|
8 |
No abnormalities detected |
No abnormalities detected |
|
9 |
No abnormalities detected |
No abnormalities detected |
|
10 |
No abnormalities detected |
No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute dermal median lethal dose of test chemical was >2000 mg/kg body weight.It can be classified under CLP Classification: “Category- Not classified”.
- Executive summary:
Acute Dermal Toxicity Study of test chemical in Wistar Rats, was performed as per OECD No.402.
Five male and five female healthy young adult rats were selected and used for conducting acute dermal toxicity study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item was applied by single dermal application and observed for 14 days after treatment.
On test day 0 test item was applied directly on the intact skin of clipped area of rats; the surgical gauze patch was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating adhesive tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed.
The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were recorded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality was observed in any animal till the end of the experimental period. No systemic or local signs of toxicity were observed at limit dose of 2000 mg/kg body weight of test item during the experimental period, except female animal nos. 8 and 10 were observed with erythema from day 2 to 8 and scab from day 9 to 12.
Body weight gain was observed in male and female animals on day 7 and 14 as compared to day 0, except decline in mean body weight gain was observed in males on day 7. External and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.
Thus, acute dermal median lethal dose of test chemical was >2000 mg/kgbody weight and can be classified as CLP Classification: “Category- Not classified”.
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