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EC number: 292-960-4 | CAS number: 91031-57-1
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 Nov - 13 Dec 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- (22 Mar 1996)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behoerde fuer Soziales, Familie, Gesundheit und Verbraucherschutz; Hamburg, Germany
- Limit test:
- no
Test material
- Reference substance name:
- Isodecyl oleate
- EC Number:
- 261-673-6
- EC Name:
- Isodecyl oleate
- Cas Number:
- 59231-34-4
- Molecular formula:
- C28H54O2
- IUPAC Name:
- 8-methylnonyl octadec-9-enoate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Research Models and Services Germany GmbH, Sulzfeld, Germany
- Age at study initiation: males: 50 days; females: 60 days
- Mean weight at study initiation: males: 248.8 to 298.7 g; females: 195.2 to 228.1 g
- Fasting period before study: no
- Housing: single housing in MAKROLON cages (type III plus)
- Diet: commercial ssniff R-Z V1324 (ssniff Spezialdiäten GmbH, Soest, Germany); ad libitum
- Water: tap water; ad libitum
(Analyses of diet and water was performed.)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 50, 150 and 500 mg/mL
- Amount of vehicle (if gavage): 2 mL/kg - Details on mating procedure:
- - M/F ratio per cage: 1 male and 1 female animal were placed in one cage during the dark period
- Length of cohabitation: The female was placed with the same male until pregnancy had occurred or 2 weeks had elapsed.
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy
- After 2 weeks of unsuccessful pairing replacement of first male by another male with proven fertility.
- After successful mating each pregnant female was caged singly. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- For the analysis of the test item-vehicle mixtures samples were taken at the following time points and stored at ≤ -20°C until analysis:
Start of treatment period; immediately after preparation of the test item-vehicle mixtures; 8 and 24 hours after storage of the test item preparations at room temperature; end of treatment period; during treatment with the test item always before administration to the last animal of the dose level group
The following parameters were determined: linearity, accuracy, precision, sensitivity, specificity, stability at +2°C to +8°C or -20°C (0, 24, 72 and 168 hours) - Duration of treatment / exposure:
- Males: The daily administration of the test item was started two weeks before mating and lasted until test day 35, which was one day before sacrifice.
Females: The daily administration of the test item was started two weeks before mating and continued to at least day 3 of lactation.
Maximum: 56 days of treatment - Frequency of treatment:
- once daily; 7 days/week
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
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on a 14-day range-finding study (Leuschner, 2012)
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: before and after dosing
- Cage side observations checked: skin/fur, eyes, mucous membranes, respiratory and circulatory systems, somatomotor activity and behaviour patterns
MORTALITY AND CLINICAL SIGNS
- Time schedule: at least once daily (the frequency was increased when signs of toxicity were observed); deaths were recorded twice daily (animals which died or were sacrificed during the study were necropsied as soon as possible after exitus)
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once before the first exposure (to allow within-subject comparisons) and once a week thereafter
- Paramters: changes in skin, fur, eyes, mucous membranes, occurrence of secretions and excretions and autonomic activity (e.g. lacrimation, pilo-erection, pupil size, and unusual respiratory pattern); changes in gait, posture and response to handling as well as the presence of clonic or tonic movements, stereotypies (e.g. excessive grooming, repetitive circling), difficult or prolonged parturition or bizarre behaviour (e.g. self-mutilation, walking backwards)
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/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
For further systemic effects (water intake, haematology, clinical chemistry, neurobehaviour), see "Repeated dose toxicity: oral" (chapter 7.5.1)
OTHER
Reproduction paramters: number of pregnant females, pre-coital time, gestation length - Sperm parameters (parental animals):
- Parameters examined in P male parental generations:
testis weight, epididymis weight, and qualitative sperm staging - Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: yes
- If yes, maximum of all pups/litter
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring: litter weight, number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies
GROSS EXAMINATION OF DEAD PUPS:
Yes, for external and internal abnormalities - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals [males were sacrificed on day 36]
- Maternal animals: All surviving animals [females were sacrifices on day 4 post-partum or shorty thereafter]
GROSS PATHOLOGY: Yes
- Organ weights: epididymes and testicles (all males); adrenal gland, brain, heart, kidney, liver, spleen, thymus (5/sex/dose)
- Fixation: epididymis, gross lesions, mammary gland, ovary, prostate, seminal vesicle, testicle, uterus (incl. cervix and oviducts), vagina (all animals); adrenal gland, bone marrow (os femoris), brain (cerebrum, cerebellum, brain stem), heart (left and right ventricle, septum), intestine, small (duodenum, jejunum, ileum, incl. Peyer's patches, Swiss roll method), intestine, large (colon, rectum), kidney and ureter, liver, lungs (with mainstem bronchi and bronchioles), preserved by inflation with fixative and then immersion, lymph node (1 cervical, 1 mesenteric), nerve (sciatic), oesophagus, spinal cord (3 sections), spleen, stomach, thyroid (incl. parathyroids), thymus, tissue masses or tumours (incl. regional lymph nodes), tongue (incl. base), trachea (incl. larynx), urinary bladder (5/sex/dose)
HISTOPATHOLOGY: Yes, all organs that were included for fixation (5/sex of control and high dose group) - Postmortem examinations (offspring):
- SACRIFICE
- The surviving F1 offspring were sacrificed at 4 days of age.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) as follows:
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations]
Dead pups and pups sacrificed at day 4 post-partum, or shortly thereafter, were carefully examined externally for gross abnormalities.
HISTOPATHOLOGY / ORGAN WEIGTHS
not performed - Statistics:
- STUDENT's t-test (p ≤ 0.01): all numerical functional tests
Multiple t-test based on DUNNETT (p ≤ 0.05 and p ≤ 0.01): body weight, food consumption, haematology, clinical chemistry, absolute and relative organ weights
For all numerical values homogeneity of variances was tested by using the BARTLETT chi-square test. If the variances were homogeneous, the DUNNETT test (p ≤ 0.01) was used to compare the experimental groups with the control group. In case of heterogeneity of variances, the STUDENT's t-test was carried out; limit of significance was p ≤ 0.01. - Reproductive indices:
- For each group the gestation index was determined:
- Fertility Index female [%] = Number of pregnant rats/Number of females used x 100
- Gestation Index [%] = Number of litters with live pups/Number of pregnant rats x 100 - Offspring viability indices:
- For each litter and group the following indices were determined:
- Birth Index [%] = Total number of pups born (live + dead)/Number of implantation scars x 100
- Live Birth Index [%] = Number of pups born alive on day 0/1 Total number born (live + dead) x 100
- Viability Index [%] = Number of pups alive on day 4/Number of pups live on day 0/1 x 100
- Pre-implantation loss [%] = Corpora lutea - implantations/Corpora lutea x 100
- Post-implantation loss [%] = Implantations - number of pups born alive/Implantations x 100
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Piloerection was seen in 1 female of the high dose group at on day 2-4 of lactation.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduction in body weight (-9.4%) in high dose females during lactation period.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Reduction in food intake (-21.7%) in high dose females during gestation/lactation.
- Food efficiency:
- not examined
- 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:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Description (incidence and severity):
- - Pre-coital time: No effects observed
- Gestation length: No effects observed - Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- The qualitative sperm staging revealed no test item-related specific spermatogenic changes in the male animals from the high dose group (1000 mg/kg b.w./day).
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- Reproduction parameters of the dams: statistically significant increase in post implantation loss, non-statistically significant decrease in birth index, elevated number of stillbirths, leading to a statistically significant reduction in the live birth index in highest dose group (1000 mg/kg bw/day).
Details on results (P0)
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: adverse effects on body weight and body weight gain and food consumption at 1000 mg/kg bw/d
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- reproduction
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: an increase in post-implantation loss, a decrease in the birth index and a decrease in the live birth index at 1000 mg/kg bw/d
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- reproduction
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no spermatogenic changes
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- A test item-related decrease in the viability index was noted in the high dose group (1000 mg/kg bw/day) (71.3 % in the high dose group vs. 98.7% in the control group). The high number of dead pups in the high dose group was due to 2 dams with no surviving pups on lactation day 4 (deaths partly due to cannibalization). The total litter loss in 2 of 7 dams (28.6%) was considered as test item related.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- A non-statistically significant reduction in mean litter weight on lactation day 1 by 17.2% was noted in the high dose group (high dose group), which is regarded to be test item-related. Total litter weight was also reduced by 24.4% in comparison to controls.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- developmental
- Generation:
- F1
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- other: effects on litter weight at 1000 mg/kg bw/day
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects as a secondary non-specific consequence of other toxic effects
- Dose response relationship:
- yes
- Relevant for humans:
- no
Any other information on results incl. tables
Individual body weights of females during the pre-mating and lactation period.
Control group |
Day(s) relative to start |
||
|
1 |
8 |
15 |
11 |
196 |
209 |
212 |
12 |
217 |
228 |
243 |
13 |
210 |
220 |
213 |
14 |
217 |
234 |
244 |
15 |
3211 |
215 |
232 |
16 |
195 |
208 |
197 |
17 |
205 |
224 |
239 |
18 |
212 |
238 |
233 |
19 |
224 |
236 |
259 |
20 |
200 |
218 |
214 |
Mean |
209 |
223 |
229 |
SD |
9 |
10 |
19 |
1000 mg/kg bw |
Day(s) relative to start |
||
|
1 |
8 |
15 |
71 |
200 |
210 |
225 |
72 |
210 |
231 |
234 |
73 |
206 |
234 |
247 |
74 |
210 |
222 |
235 |
75 |
194 |
219 |
218 |
76 |
218 |
243 |
223 |
77 |
214 |
230 |
227 |
78 |
222 |
225 |
210 |
79 |
198 |
200 |
201 |
80 |
203 |
223 |
231 |
Mean |
207 |
224 |
225 |
SD |
9 |
12 |
13 |
Control group |
Day(s) relative to littering |
|
|
1 |
4 |
11 |
286 |
309 |
12 |
323 |
330 |
13 |
325 |
311 |
14 |
331 |
327 |
15 |
311 |
322 |
16 |
282 |
302 |
17 |
309 |
327 |
18 |
312 |
328 |
19 |
315 |
331 |
20 |
300 |
329 |
Mean |
309 |
322 |
SD |
16 |
10 |
1000 mg/kg bw |
Day(s) relative to littering |
|
|
1 |
4 |
71 |
270 |
281 |
72 |
339 |
301 |
73 |
289 |
309 |
75 |
289 |
317 |
77 |
253 |
247 |
78 |
280 |
271 |
79 |
290 |
296 |
80 |
293 |
308 |
Mean |
288 |
291 |
SD |
24 |
23 |
Relative food consumption of females between day 1 and 4 of lactation
Control group |
1000 mg/kg bw |
||
|
|
||
11 |
122 |
71 |
115 |
12 |
91 |
72 |
96 |
13 |
105 |
73 |
63 |
14 |
107 |
75 |
110 |
15 |
106 |
77 |
30 |
16 |
121 |
78 |
63 |
17 |
114 |
79 |
98 |
18 |
100 |
80 |
110 |
19 |
101 |
|
|
20 |
126 |
|
|
Mean |
109 |
Mean |
86 |
SD |
11 |
SD |
30 |
Viability index [%], day 1 to 4 of lactation
Control group |
1000 mg/kg bw |
||
|
|
|
|
11 |
93 |
71 |
93 |
12 |
100 |
72 |
100 |
13 |
100 |
73 |
0 |
14 |
93 |
74 |
not pregnant |
15 |
100 |
75 |
100 |
16 |
100 |
76 |
not pregnant |
17 |
100 |
77 |
0 |
18 |
93 |
78 |
no viable pubs |
19 |
89 |
79 |
100 |
20 |
100 |
80 |
100 |
Mean |
96 |
Mean |
70 |
SD |
4 |
SD |
48 |
Summary of Live Birth Index, Pre-implantation loss, and Post-implantation loss in female animals
|
Control group |
100 mg/kg bw |
300 mg/kg bw |
1000 mg/kg bw |
Live Birth Index |
|
|
|
|
Mean |
100 |
100 |
100 |
86 |
SD |
0 |
0 |
0 |
35 |
Total %1 |
100 |
100 |
100 |
91 |
|
|
|
|
|
Pre-implantation loss |
|
|
|
|
Mean |
2.4 |
18.3 |
0.6 |
8.1 |
SD |
3.1 |
26.0 |
2.0 |
9.8 |
Total %2 |
2.5 |
20.3** |
0.7 |
9.1* |
|
|
|
|
|
Post-implantation loss |
|
|
|
|
Mean |
7.6 |
9.0 |
7.5 |
20.8 |
SD |
10.5 |
14.8 |
8.8 |
32.9 |
Total %3 |
7.6 |
10.2 |
7.7 |
21.7** |
*:p < 0.05 / **: p < 0.01, Chi2-test
#1: based on the total number of live born pups and the total number of pups at birth (alive and dead)
#2: based on the total number of corpora lutea and the total number of implantation sites
#3: based on the total number of implantation sites and the total number of live born pups
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.