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EC number: 237-725-9 | CAS number: 13945-76-1
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 Mar - 12 May 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- No neurological examinations were performed, no clinical observations outside the home cage, the test substance was administered 5 days/week, the analytical purity of the test substance was not specified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- yes
- Remarks:
- no neurological examinations performed, no clinical observations outside the home cage
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- no neurological examinations performed, no clinical observations outside the home cage
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Fatty acids, C8-10, C12-18-alkyl esters
- EC Number:
- 306-082-7
- EC Name:
- Fatty acids, C8-10, C12-18-alkyl esters
- Cas Number:
- 95912-86-0
- Molecular formula:
- Not applicable, substance is UVCB
- IUPAC Name:
- 95912-86-0
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Wistar Bor:WISW (SPF) Cpb
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: approximately 4 weeks
- Weight at study initiation: 44-61 g (males), 46-60 g (females)
- Housing: 2-3 animals of the same sex in macrolon cages, type III with wood shavings (ARWI-Center, Essen, Germany)
- Diet: nitrosamine-poor pellets, Altromin 1324 DK (Fa. Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): 41-55
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25 Feb 1992 To: 9-10 Mar 1992 (main groups), 12 May 1992 (satellite groups)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% carboxymethylcellulose and 0.25% cremophor in aqua dest. (CMCC)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: dosing solutions were prepared daily prior to administration. The application volumes were adopted weekly to the current body weights.
VEHICLE
- Concentration in vehicle: 1, 2 and 10% for the 100, 300 and 1000 mg/kg bw/day groups, respectively.
- Amount of vehicle (if gavage): 10 mL/kg bw - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 28 days (control and treatment group)
28 days and 33 days post-exposure observation period (satellite control and treatment group) - Frequency of treatment:
- once daily, 5 days/week (23-24 doses in total)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10 (main groups)
5 (satellite groups) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: the dose levels were selected in order to find the highest possible safety margin for the determination of the non-cumulative toxic dose level and the determination of toxic dose ranges.
- Rationale for selecting satellite groups: satellite control and high-dose groups were selected to determine the reversibility of potentially cumulative toxic effects
- Post-exposure recovery period in satellite groups: 33 days
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: the animals were observed for mortality and clinical signs twice daily (once daily during weekends and public holidays)
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No, the intake per cage per week was recorded and calculated as g/rat/week
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: Yes
- Time schedule for examinations: once weekly, per cage
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: one day prior to the sacrifice of the animals. Mydriaticum Roche R (Hoffmann-La Roche, Grenzach-Wyhlen) was instilled into the right eye, which was then examined using a Topcon-SL-5D slit lamp (Bon, D-Wahlstedt).
- Dose groups that were examined: control and 1000 mg/kg bw/day group
HAEMATOLOGY: Yes
- Time schedule for collection of blood: prior to necropsy
- Anaesthetic used for blood collection: Yes (ether)
- Animals fasted: No
- How many animals: all animals in the main groups
- Parameters examined: haematocrit, haemoglobin content, red blood cell count, white blood cell count, mean cell volume, thrombocyte cell count, differential blood count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: prior to necropsy
- Animals fasted: No
- How many animals: all animals in the main groups
- Parameters examined: gamma-glutamyl transferase, aspartate-aminotransferase, alanine-aminotransferase, alkaline phosphatase, sodium, potassium, glucose, urea, total protein, calcium, creatinine, cholesterol, chloride, bilirubin
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. The animals in the main groups and satellite groups were sacrificed using an overdose of ether and gross pathology was conducted with all animals. The eyeballs and the inner organs were removed and fixed in 10% neutral formalin solution (Formol-Fixx-Concentrate, Shandon). The weight of the brain, testes, heart, liver, spleen, adrenals, kidneys and thymus of all main and satellite groups was recorded.
HISTOPATHOLOGY: Yes. For the control and 1000 mg/kg bw/day groups, the following organs were histologically examined: aorta thoracica, eyes, colon, stomach, small intestine, cerebrum, urinary bladder, skin, heart, testes, hypophysis, cerebellum, liver, trachea, lung, axilliary lymph nodes, mesenteric lymph nodes, spleen, epididymides, adrenals, periphery nerve, kidneys, ovaries, pancreas, prostate, seminal vesicle, thyroid, salivary gland, oesophagus, sceletal muscle, thymus, uterus, forestomach, tongue.
In the satellite groups and the 500 mg/kg bw/day main group, the forestomach was examined as a target organ. - Statistics:
- The inter-groups variations for body weight, clinical chemistry and hematology were determined using a t-test. The differences in organ weight were evaulated using a Steel-test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs were observed during the study period.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- 100 mg/kg bw/day: 1/10 females died at the end of the study during the collection of blood (not test substance-related). There was no substance-related mortality.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There was no difference in body weight gain between the control and treatment groups.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There was no statistically significant difference in food consumption between the control and treatment groups.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- There was no statistically significant difference in water consumption between the control and treatment groups. The females in the 1000 mg/kg bw/day group showed an increase in water consumption in week 2, however, as this was due to a mechanical failure this is not considered to be a relevant finding (see Table 1).
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- There were no substance-related changes to the eyes of the examined animals.
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The males administered 1000 mg/kg bw/day had a significant increase in the level of leucocytes with segmented nuclei (see Table 2). As this effect was non-adverse and only observed in one sex and there were no other hematologic or histopathologic effects, this is not considered to be a treatment-related effect.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In males administered 1000 mg/kg bw/day, the ALT-level was statistically significantly increased (see Table 3). This increase in a liver enzyme may be caused by an increase in the liver metabolism due to the test substance. However, no other effects were seen on clinical chemistry parameters or in the histopathological results and the effects are considered not to be of toxicological relevance (non-adverse). An increase in the protein- and calcium levels of males in the 100 mg/kg bw/day group is not considered to be substance-related as these increases were not observed at any other dose level and in one sex only.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 300 mg/kg bw/d: increased relative heart weight, males; 100 mg/kg bw/day: increased relative/absolute heart weight, males (non-adverse)
A slight decrease was observed in the relative and absolute heart weight of males in the 100 mg/kg bw/day group and in the relative heart weight in males in the 300 mg/kg bw/day group (see Table 4). As no effect was observed in the highest dose group, this is not deemed to be a treatment-related effect. - Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 1/10 females administered 1000 mg/kg bw/day had severe oedema in the forestomach and 1/10 had thickening of the forestomach mucosa. These findings were probably compound-related, however, humans do not have a forestomach and this effect is therefore not relevant to human exposure. No other effects were noted during necropsy.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- 1000 mg/kg bw/day: effects on the mucosa of the forestomach
4/10 males and 2/10 females in the 1000 mg/kg bw/day group had oedema in the mucosa of the forestomach, and the 2 females also had ulcerations (see Table 5). These findings were probably compound-related, however, as humans do not have a forestomach this effect is not relevant to human exposure. As none of the animals in the satellite group had effects on the forestomach, this is considered to be a reversible effect. - Histopathological findings: neoplastic:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related effects were observed up to and including the highest dose level
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- System:
- gastrointestinal tract
- Organ:
- other: forestomach
- Treatment related:
- yes
- Dose response relationship:
- no
- Relevant for humans:
- no
Any other information on results incl. tables
Table 1: Water consumption as group mean value (mL/animal/day)
|
Group (mg/kg bw/day) |
|||||||
|
Males |
Females |
||||||
Week |
Control |
100 |
300 |
1000 |
Control |
100 |
300 |
1000 |
1 |
209 |
196 |
205 |
197 |
156 |
154 |
159 |
155 |
2 |
209 |
215 |
217 |
192 |
145 |
152 |
158 |
195 |
3 |
229 |
215 |
209 |
207 |
138 |
141 |
147 |
149 |
4 |
217 |
208 |
203 |
211 |
141 |
143 |
145 |
149 |
Table 2: Haematological results
|
Group (mg/kg bw/day) |
|||||||
|
Males |
Females |
||||||
|
Control |
100 |
300 |
1000 |
Control |
100 |
300 |
1000 |
leucocytes with segmented nuclei (%) |
0.3 |
0.1 |
0.4 |
1.1* |
0.7 |
0.7 |
0.7 |
0.7 |
*Statistically significant (p < 0.01)
Table 3: Clinical chemistry
|
Group (mg/kg bw/day) |
|||||||
|
Males |
Females |
||||||
|
Control |
100 |
300 |
1000 |
Control |
100 |
300 |
1000 |
ALT (U/L) |
30 |
30 |
30 |
40* |
23 |
23 |
21 |
27 |
Protein (g/L) |
60 |
62** |
61 |
60 |
63 |
63 |
63 |
63 |
Calcium (mmol/L) |
2.3 |
2.4** |
2.4 |
2.4 |
2.4 |
2.4 |
2.4 |
2.4 |
*Statistically significant (p < 0.01)
**Statistically significant (p < 0.05)
Table 4: Organ weights
|
Group (mg/kg bw/day) |
|||||||
|
Males |
Females |
||||||
|
Control |
100 |
300 |
1000 |
Control |
100 |
300 |
1000 |
Heart, absolute (g) |
0.84 |
0.75** |
0.77 |
0.82 |
0.58 |
0.61 |
0.59 |
0.60 |
Heart, relative (%) |
0.34 |
0.32** |
0.31* |
0.33 |
0.36 |
0.36 |
0.36 |
0.37 |
*Statistically significant (p < 0.01)
**Statistically significant (p < 0.05)
Table 5: Histopathological effects
|
Group (mg/kg bw/day) |
|||||||
|
Males |
Females |
||||||
|
Control |
100 |
300 |
1000 |
Control |
100 |
300 |
1000 |
Edema in forestomach |
0/10 |
- |
- |
4/10 |
0/10 |
- |
- |
2/10 |
Ulcer(s) in forestomach |
0/10 |
- |
- |
0/10 |
0/10 |
- |
- |
2/10 |
|
|
|
|
|
|
|
|
|
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.
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.