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EC number: 231-306-4 | CAS number: 7491-02-3
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 31 Jan - 10 Apr 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles. Purity of test substance not given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- purity of test substance not given
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- purity of test substance not given
- Deviations:
- yes
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 69275-01-0
- Cas Number:
- 69275-01-0
- IUPAC Name:
- 69275-01-0
- Details on test material:
- - Name of test material (as cited in study report): Di-(2-octyl-dodecyl)-sebacate
- Physical state: colorless liquid
- Storage condition of test material: room termperature
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain as given in the study report: Sprague-Dawley CD SPF
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: 4 weeks
- Weight at study initiation: 56 - 72 g (males); 55 - 76 g (females)
- Housing: 2-3 animals per cage in Makrolon type III cages
- Diet: pelleted, low count, low nitrosamine Altromin 1324 diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 24.9
- Humidity (%): 43 -56
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: oleum Arachidis, DAB8
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Dosing solutions were prepared daily shortly before applications by dissolving test substance in oleum arachidis, DAB8 yielding final concentrations of 2, 7 and 20 %
VEHICLE
- Concentration in vehicle: 20 mg/mL for 100 mg/kg bw dose group, 70 mg/mL for 350 mg/kg bw dose group, 200 mg/mL for 1000 mg/kg bw dose group
- Amount of vehicle (if gavage): 5 mL/kg - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 28 days (control and test groups)
Additional animals (5/sex/group) for both the control and the high dose group were maintained for further 28 treatment-free days, for purpose of recovery testing. - Frequency of treatment:
- once daily, 5 days a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 350 and 1000 mg/kg bw/d (group 2, 3 and 4, respectively)
Basis:
actual ingested
- No. of animals per sex per dose:
- test groups: 10
recovery groups (control, high dose group): 5 - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Doses were selected to achieve the a maximal high safety margin, to determine a not cumulative toxic dose and to determine toxic ranges.
- Rationale for selecting satellite groups: Establish reversibility of possible cumulative effects.
- Post-exposure recovery period in satellite groups: 28 days
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily for mortality and clinical symptoms
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/animal/day: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: day before sacrifice
- Dose groups that were examined: groups 1 and 4
HAEMATOLOGY: Yes
- Time schedule for collection of blood: after 4 weeks of application
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all
- Parameters checked in table [No.1] were examined (erythrocytes number, haematocrit, middle cell volume, haemoglobin, leucocyte numbers, thrombocyte numbers, differential blood count).
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 4 weeks of application
- How many animals: all animals
- Parameters checked in table [No.2] were examined (GGT, GOT, GPT, alkaline phosphatase, sodium, potassium, glucose, urea, protein, calcium, creatinine, cholesterol, chloride, bilirubine). - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, absolute and relative organs weights were determined for brain, testicles, heart, liver, spleen, adrenals, kidneys, thymus
HISTOPATHOLOGY: Yes, following organs were subjected to histopathological examinations: aorta thoracica, eye, colon, glandular stomach, cerebrum, urinary bladder, skin, heart, testicles, liver, cerebellum, trachea, lung, maxillar lymph node, mesenterial lymph node, spleen, epididymis, adrenal, peripheral nerve, kidney, ovaries, pancreas, prostate, seminal gland, thyroid, salivary gland, oesophagus, thymus, uterus, tongue, proventriculus, skeletal muscles - Statistics:
- T-test for determination of significant differences for body weights, blood evaluation and biochemical examinations
U-test for determination of significant differences for organ and bone weights
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- non adverse
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- non adverse
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- treated females of all 3 test groups
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- increased food intake in females of the middle and high dose group
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- non adverse, significant reduction of GOT values in the middle and high dose groups of both sexes and in the females of the low dose group
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
thin fur, alopecia, chromodacryorrhoe, sporadically slight scrapes (considered not to be substance-related; no details on affected sex or groups)
BODY WEIGHT AND WEIGHT GAIN
Increased food consumption and increased body weight gain were observed in the females of middle and high dose group:
group 2 - slight increase during week 4, groups 3+4 - slight increase during week 3 and strong increase after week 4 (see table 3)
FOOD CONSUMPTION AND COMPOUND INTAKE
slightly increased (compared to the control group) for females of group 3 during week 2 - 4, for females of group 4 during week 1, 2 and 4
HAEMATOLOGY
no toxic or dose-dependent effects
CLINICAL CHEMISTRY
The significant reduction of GOT values in females of all test groups (26% to 35% reduction) and males of the middle and high dose group (16% to 22% reduction) may be explained by elevation of mean values of GOT compared to historical controls.
GROSS PATHOLOGY
Insidences of hydrometra and hydronephrosis as well as different forms of testicular atrophy and edema of the proventricular mucosa were observed. As these findings were incidental in control groups they were not considered substance-related. No gross pathological findings were observed in thw recovery group.
HISTOPATHOLOGY: NON-NEOPLASTIC
The observed incidental pathological findings could be histopathological verified. No other histopathological effects were evident.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: NOAEL corresponding to the highest dose tested.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 3: Mean body weight and body weight gain values (g) of rats treated with the test item in the feed for 28 days:
body weight gain | ||||||||
males |
females | |||||||
week | control | 100 mg/kg bw | 350 mg/kg bw | 1000 mg/kg bw | control | 100 mg/kg bw | 350 mg/kg bw | 1000 mg/kg bw |
0 | 158 | 159 | 165 | 158 | 136 | 139 | 137 | 141 |
1 | 210 | 211 | 220 | 214 | 158 | 163 | 164 | 166 |
2 | 267 | 271 | 280 | 269 | 179 | 184 | 189 | 190 |
3 | 315 | 323 | 332 | 323 | 193 | 203 | 209* | 209* |
4 | 355 | 362 | 373 | 262 | 202 | 217* | 225** | 225** |
gain 0-4 | 197 | 203 | 208 | 204 | 66 | 78 | 88 | 84 |
*significant different (p>0,05); **significant different (p>0.01)
Applicant's summary and conclusion
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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