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EC number: 939-582-4 | CAS number: 1471315-26-0
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline Study, tested with the source substance CAS 124-07-2. In accordance to ECHA guidance document "Practical guide 6: How to report read-across and categories (May 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Developmental Toxicity and Structure-Activity Relationships of Aliphatic Acids, Including Dose-Response Assessment of Valproic Acid in Mice and Rats
- Author:
- Narotsky, M.G. et al.
- Year:
- 1 994
- Bibliographic source:
- Fundamental and Applied Toxicology 22(2):251-65
Materials and methods
- Principles of method if other than guideline:
- Octanoic acid was evaluated in the Chernoff/Kavlock developmental toxicity screen in rats.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Octanoic acid
- EC Number:
- 204-677-5
- EC Name:
- Octanoic acid
- Cas Number:
- 124-07-2
- IUPAC Name:
- octanoic acid
- Details on test material:
- - Name of test material (as cited in study report): octanoic acid (OCT)
- Analytical purity: 99.5%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, NC, USA
- Diet: Purina Lab Chow No. 5001, ad libitum
- Water: tap-water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2 ± 1.1
- Humidity (%): 50 ± 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- VEHICLE
- Amount of vehicle (if gavage): 2 mL/kg bw - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - Proof of pregnancy: vaginal plug or vaginal sperm referred to as day 0 of pregnancy
- Duration of treatment / exposure:
- Day 6-15 of gestation
- Frequency of treatment:
- once daily
- Duration of test:
- 28 days (22 days of gestation and 6 days post natal)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1125 and 1500 mg/kg bw/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 16 females (test groups); 20 females (control)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on a preliminary range-finding study. The highest dose was expected to induce moderate maternal toxicity and the lowest dose was set to 75% of the highest dose.
Examinations
- Maternal examinations:
- CLINICAL OBSERVATIONS: Yes
- Time schedule: throughout the experimental period; beginning on gestational day 20, the dams were observed up to seven times during the normal workday to determine the time of parturition
BODY WEIGHT: Yes
- Time schedule for examinations: on gestation day 6, 8, 10, 13, 16 and 20 - Ovaries and uterine content:
- Dams were killed on PND 6 and the number of uterine implantation sites was determined.
- Fetal examinations:
- Pups of each litter were examined and counted on PND 1, 3 and 6. Body weights were determined collectively on PND 1 and 6.
- External examinations: Yes: all per litter
- Soft tissue examinations: Yes: pups found dead and externally malformed pups
- Skeletal examinations: Yes: externally malformed pups and 2 surviving pups per litter (one per sex) - Statistics:
- Statistical analysis were based on general linear models (GLM), analysis of variance and Student's t test
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Mortality rates of 31 (5/16) and 44% (7/16) were observed in the low- and high-dose group. As the number includes deaths which occured shortly after dosing, mortaility due to paragastric intubation cannot be excluded. However, most deaths were attributed to the respiratory effects of treatment visible as rales and dyspnea which might be induced by gastroesophagal reflux and subsequent aspiration of dosing solution (please refer to Table 1).
Reduced body weight gain was observed in test animals reaching statistical significance in the high-dose group already in the early treatment period (gestation day 6 – 10) and in both dose groups in the late treatment period (gestation day 6 – 20).
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 1 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Gestation length observed in control and treated animals were comparable.
The number of live pups did not differ between control and low-dose animals but was significantly reduced in the high-dose group on PND 6. As dams in this dose group showed severe peripartum respiratory symptoms, the decreased viability of pups might be due to maternal toxicity. Further, the rate of perinatal loss increased for high-dose dams but did not reach statistical significance. Pup weights determined in PND 1 or 6 were comparable among the groups and no malformations including lumbar ribs were noted.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1: Clinical findings and maternal body weight changes in the Chernoff/Kavlock Assay
|
|
control group (20 rats) |
1125 mg/kg bw/day (16 rats) |
1500 mg/kg bw/day (16 rats) |
Clinical signs |
deatha no. (%) |
0 |
5 (31%) |
7 (44%) |
rales no. (%) |
0 |
15 (95%) |
15 (95%) |
|
dyspnea no. (%) |
0 |
4 (25%) |
7 (44%) |
|
motor depression no. (%) |
0 |
0 |
0 |
|
Body Weight change |
GD 6 – 10 (g) |
15.6 ± 1.5 |
4.9 ± 5.7 |
-24.0 ± 8.7*** |
GD 6 – 20 (g)b |
42.8 ± 3.1 |
15.3 ± 5.2*** |
-5.7 ± 6.2*** |
a: the number includes deaths which occurred shortly after dosing and might be due to paragastric intubation
b: adjusted to live litter weight on PND 1
***: significantly different from concurrent control with p < 0.001
Table 2: Developmental data
|
control group (15 rats) |
1125 mg/kg bw/day (11 rats) |
1500 mg/kg bw/day (9 rats) |
No. implants |
12.4 ± 1.2 |
13.4 ± 0.8 |
11.9 ± 1.1 |
No. live pups PND 1 |
10.4 ± 1.2 |
12.1 ± 0.8 |
9.5 ± 1.1 |
No. live pups PND 6 |
10.3 ± 1.1 |
11.8 ± 0.7 |
7.4 ± 1.7* |
Perinatal lossc(%) |
20.1 ± 6.7 |
10.8 ± 2.6 |
35.8 ± 11.9 |
Pup weight on PND1 |
7.4 ± 0.1 |
7.0 ± 0.2 |
6.8 ± 0.4 |
Pup weight on PND6 |
14.3 ± 0.4 |
13.8 ± 0.4 |
13.0 ± 1.2 |
PND: postnatal day
c: perinatal loss = implants not surviving until PND6 (analysis of this endpoint included litters that were delivered late)
*: significantly different from concurrent control with p < 0.05
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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