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EC number: 203-965-8 | CAS number: 112-38-9
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-01-18 till 2007-02-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Undec-10-enoic acid
- EC Number:
- 203-965-8
- EC Name:
- Undec-10-enoic acid
- Cas Number:
- 112-38-9
- Molecular formula:
- C11H20O2
- IUPAC Name:
- undec-10-enoic acid
- Details on test material:
- - Name of test material (as cited in study report): Undecylenic Acid / Acide Undecylenique
- Physical state: white solid
- Analytical purity: 98.75
- Lot/batch No.: 0607007 filling 0022/06
- Expiration date of the lot/batch: 2007-12-22
- Storage condition of test material: at RT, protected from light
- Purity test date: 06/04/2006
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS (Caesarian-obtained, barrier-sustaines, virus-antibody free pregnant animals)
- Source: Charles River, L`Arbresle, France
- Age at study initiation: 11 weeks
- Weight at study initiation: 212-312 g
- Fasting period before study:
- Housing: barrier rodent unit, housed individually in suspended wire-mesh cages
- Diet (e.g. ad libitum): ad lib. access to pelleted standard diet
- Water (e.g. ad libitum): ad lib. access to 0.22 um-filtered tap water
- Acclimation period:3,4, or 5 days (delivered as mated females from supplier)
-individual identification by ear tattoo
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 50+/-20
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
-mixing: magnetic stirrer
-Rate of preparation of solution (frequency): for up to 4 / 9 days
- Storage temperature of solution: 4°C
VEHICLE
- Justification for use and choice of vehicle (if other than water): not soluble in water
- Concentration in vehicle: 30,90,150 mg/mL
- Amount of vehicle (if gavage): 5 ml/kg BW/day
- Lot/batch no. (if required): batch No. 015K0115 (Sigma)
- Purity:98.79 % - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- by HPLC-UV;
deviations from nominal value: 3-9%;
compound in vehicle stable over 9 days at 4°C; - Details on mating procedure:
- - Impregnation procedure: purchased timed pregnant
- Proof of pregnancy: vaginal plug referred to as day 0 post coitum - Duration of treatment / exposure:
- from day 6 to day 20 post coitum
- Frequency of treatment:
- once daily
- Duration of test:
- 15 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 450 mg/kg bw/day (nominal)
- Dose / conc.:
- 750 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 24 animals/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: preliminary study
Examinations
- Maternal examinations:
- MORBIDITY/MORTALITY/CLINICAL SIGNS: Yes
- Time schedule: once to twice a day during treatment, afterwards once a day
BODY WEIGHT: Yes
- Time schedule for examinations: days 2,4,6,9,12,15,18,21 post coitum
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as mg food/kg body weight/day: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 21 (high-dose group between day 8 and 16 p.c.)
- macroscopic examination of the principal thoracic and abdominal organs
OTHER: fixation and collection of macroscopic lesions - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Number and ditribution of dead/life fetuses: Yes
- Number and distribution of uterine scars: Yes
- Other: gross evaluation of placentas, macroscopic lesions fixec and collected - Fetal examinations:
- - External examinations/fetal weights/sex: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter - Statistics:
- Mean values: one-way ANOVA with Dunnett`s test
Percentage Values: Fisher exact probability test - Indices:
- body weight change, net body weight (chnage), total number of resorptions, total number of dead fetuses, % of dead fetuses/litter, total number of live fetuses, % of live fetuses/litter, % of pre-implantation loss, % of post-implantation loss, average fetal body weight, %of pre-implantation loss relative to number of corpora lutea
- Historical control data:
- no
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Signs of hypersalivation were noted in 24/24 and 15/24 females given 450 and 150 mg/kg/day,
from weeks 1 and 2, respectively - Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Among the 24 mated females given 750 mg/kg/day, 8 were found dead on GD 6, 7, 8, 10, 11 or 13
without ante-mortem signs of toxicity, and decision was taken to prematurely sacrifice the
survivors. No unscheduled deaths occurred at 450 or 150 mg/kg/day. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The body weight gain and net weight change of females given
450 mg/kg/day were statistically lower than controls (-11%, p<0.05 and -32%, p<0.001,
respectively). This effect on body weight was correlated with statistically significantly lower food
consumption between GD 9 and 15 (GD 9-12: -8%, p<0.05, GD 12-15: -12%, p<0.01).
At 150 mg/kg/day, the net body weight change was lower than controls but was not statistically
significant. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- The food intake was unaffected when given 150 mg/kg/day.
Food consumption of treated females at 450 mg/kg/day was lower than controls over the whole
dosing period, being statistically significant between GD 9 and GD 15 (ranging from -8% to
-12%).
At the low dose-level, the food consumption was considered to be unaffected by the test item
treatment - 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
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- There were no remarkable necropsy findings in any animals.
- Neuropathological findings:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- The mean number of resorptions was not affected by the test treatment.
There were no dead fetuses in any group treated with the test item.
The sex ratio was similar in the control and the treated groups.
The mean fetal body weight recorded in the test item-treated groups was similar to that of the
control group. - Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- All mated animals from the control group and the groups treated at 150 and 450 mg/kg/day were
pregnant with live fetuses at term. - Details on maternal toxic effects:
- Maternal toxic effects:yes
At 750 mg/kg/day, a total of eight pregnant females were found dead on GD (gestation days)
6, 7 (three females), 8, 10, 11 and 13 without ante-mortem signs of toxicity. Only signs of
hypersalivation were observed among three of them on the days preceding the death. Neither
body weight nor food consumption were affected. Female N24231 died accidentally on GD 11
because of a gavage error (the trachea was perforated). In female N24238, which was found dead
on GD 8, enlarged spleen with whitish focus was observed at necropsy. No necropsy findings
were observed in the six other animals.
Although no signs of toxicity were recorded before the death and in spite of the absence of
necropsy findings, these seven deaths were considered to be test item treatment-related.
A statistically lower body weight gain was recorded in females given 450 mg/kg/day over the
whole treatment period (-11%, p<0.05). This effect was mainly due to frank but transient decrease
in body weight gain of many females between GD 6-9. The terminal body weight was comparable
between groups, but the net weight change was statistically lower than controls (see below).
The body weight gain and body weight were unaffected by the treatment at 150 mg/kg/day.
Food consumption of treated females at 450 mg/kg/day was lower than controls over the whole
dosing period, being statistically significant between GD 9 and GD 15 (ranging from -8% to
-12%).
At the low dose-level, the food consumption was considered to be unaffected by the test item
treatment.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity decrease in body weight gain and food consumption
- Dose descriptor:
- LOAEL
- Effect level:
- 450 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
none of the parameters investigated was affected
(one fetus in the low dose group with several malformations was not considered relevant but of spontaneous origin)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 450 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1: Maternal Body Weight Gain (±SD)
Interval |
Dose in mg/kg bw/day (24 of Dams) |
|||
Control (N) |
LDT (150) |
MDT (450) |
HDT (750) |
|
Treatment: Days 6 -12 |
40 |
37 |
32** |
- |
Treatment: Days 6 -15 |
63 |
57 |
52** |
- |
Treatment: Days 6 -21 |
151 |
137 |
135* |
- |
* Significantly different (p 0.05) from the control
** Significantly different (p 0.01) from the control
Applicant's summary and conclusion
- Conclusions:
- No hints for developmental toxic effects of undecylenic acid were identified, not even in animals with clear maternal toxicity.
- Executive summary:
The potential of the test substance undecylenic acid to induce developmental toxicity was evaluated in the rat according to OECD guideline 414. Pregnant Sprague-Dawley rats were treated daily with the test substance by oral gavage between days 6 and 21 post coitum. The dams were observed during the treatement for signs of toxicity. The animals were sacrificed on day 21 post coitum and fetuses as well as maternal animals were investigated for signs of toxicity.
Unexpectedly high mortality in the high dose group led to the decision to terminate the treatment of this group. All animals of the intermediate dose group exhibited hypersalivation, and a significantly reduced body weight gain compared to control. In the low dose group, no relevant effects were observed. Hypersalivation in half of the animals was not considered as a relevant sign of toxicity.
No effects or uncommon findings were observed in the fetuses of the animals (malformations observed in a single fetus of the low dose group was considered incidental).
Consequently, the NOAEL for maternal toxicity was set to 150 mg/kg bw/day, while the LOAEL for this parameter was 450 mg/kg bw/day based on body weight and clinical signs. No signs of teratogenicity/developmental toxicity were observed in the study, and the NOAEL was set to the highest dose level, 450 mg/kg bw/day (750 mg/kg bw/day was discontinued before end of study). A LOAEL for teratogenicity was not observed.
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