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EC number: 236-942-6 | CAS number: 13557-75-0
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970-06-12 to 1971-10-13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The three-generation reproduction study was performed in 1971; there was no test guideline for such test available at that time.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Decanoic acid, 2-(1-carboxyethoxy)-1-methyl-2-oxoethyl ester, sodium salt
- Cas Number:
- 13557-74-9
- IUPAC Name:
- Decanoic acid, 2-(1-carboxyethoxy)-1-methyl-2-oxoethyl ester, sodium salt
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 12A 5022
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Day 28
- Fasting Period Prior to Study: No
- Housing: Individually housed prior to study
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): once
- Mixing appropriate amounts with (Type of food): The experimental diets were prepared by grinding appropriate amounts of the test material with a small quantity of the basal ration (Purina Laboratory Chow-Meal) in a mortar and pestle and mixing the resultant blend in a Hobart-Dayton mixer with enough basal ration to make a 6000-g batch of the desired concentration. All diets were fortified with USP cod liver oil at a concentration of 1% - Details on mating procedure:
- - M/F ratio per cage: 1 M/1 F
- Length of cohabitation: 10 day
- Proof of pregnancy: Not specified - Duration of treatment / exposure:
- Day 28 of F0 generation - end of study (weaning of F3 pups)
- Frequency of treatment:
- Daily
Doses / concentrations
- Dose / conc.:
- 20 000 ppm
- Remarks:
- Diet containing 2% of sodium stearoyl lactylate.
However, during the first six weeks of the study, rats were fed 60% of these concentrations as they eat more in proportion to body weight than subsequently.
- No. of animals per sex per dose:
- 20
- Control animals:
- yes
- Details on study design:
- Original parent rats (F0) were bred twice; the F1A pups were sacrificed at birth and part of each litter was examined either for skeletal abnormalities or for visceral changes. F1B pups were reared to weaning and pups from each litter were taken to constitute the next group of breeders. F1B rats were bred twice, and both F2A and F2B litters were reared to weaning. F2B pups were then distributed into new groups to breed the F3 generations.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly, Sacrifice
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Mean weekly food intake measured - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: No
- Number of implantations: Yes
- Number of early resorptions: No
- Number of late resorptions: No
- Other: Ovary Weights - Fetal examinations:
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- All maternal rats survived their portion of the study and were in good condition throughout.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- All maternal rats survived their portion of the study and were in good condition throughout.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no significant differences in any of the maternal generations.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There were no significant differences in any of the maternal generations.
- 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:
- no effects observed
- Description (incidence and severity):
- The gonadal weights between treated and control groups were comparable to one another.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- At necropsy no maternal generations showed gross abnormalities.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- None of the histopathological findings were to be ascribed to administration of sodium capryl lactylate, other than the questionable significance of the cortical cyst incidence in the kidneys of the females.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- not examined
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- Mean testis and ovary weights and mean total uterine implantation sites were respectively comparable among the groups.
- Total litter losses by resorption:
- not examined
- Early or late resorptions:
- not examined
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- Stillborn pups examined in the group that received test material were grossly normal.
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- There was no significant differences observed in the number of gestation days between control and treated dams.
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- No significant difference between groups.
- Other effects:
- not examined
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 20 000 ppm
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- changes in pregnancy duration
- clinical signs
- dead fetuses
- early or late resorptions
- effects on pregnancy duration
- food consumption and compound intake
- gross pathology
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- pre and post implantation loss
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- not examined
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- No significant difference was found.
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- No significant difference was found.
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- No significant difference was found.
- Changes in postnatal survival:
- no effects observed
- Description (incidence and severity):
- There was slightly lower survival at five and twenty-one days which is believed to be because of an intercurrent infection of undetermined nature.
- External malformations:
- not examined
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Skeletal anomalies seen in test group pups during any of the generations were not in frequencies high enough to be meaningful.
- Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Visceral anomalies seen in test group pups during any of the generations were not in frequencies high enough to be meaningful.
- Other effects:
- not examined
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 20 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- changes in postnatal survival
- skeletal malformations
- visceral malformations
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
None of the histopathological observations made in F3 generation were believed to be related to the administration of the test substance sodium capryl lactylate under the conditions of this study other than the questionable significance of the cortical cyst incidence in the kidneys of females.
The full tables of litter data for each generation are below.
F1A Litter Information
Observations |
Control |
Sodium Capryl Lactylate (2%) |
Litters per group |
18/20 |
17/20 |
Total live pups |
207 |
177 |
Total Stillborn |
1 |
1 |
Live pups per litter |
11.5 |
10.4 |
Mean body weights (g) of live pups |
5.53 |
5.64 |
Number of male pups |
109 |
90 |
Number of female pups |
98 |
87 |
F1B Litter Information
Observations |
Control |
Sodium Capryl Lactylate (2%) |
Litters per group |
12/20 |
12/20 |
Total live pups |
|
|
Birth |
151 |
125 |
Day 5 |
96 |
62 |
Weaning |
79 |
53 |
Total Stillborn |
0 |
1 |
Live pups per litter |
12.6 |
10.4 |
Per cent survival at day 5 |
63.6 |
49.6 |
100X weaning survival/ 5 day survival |
86.8 |
93.0 |
Mean body weights (g) of live pups at |
|
|
Birth |
5.90 |
6.02 |
Day 5 |
9.65 |
9.18 |
Weaning |
41.5 |
32.8 |
F2A Litter Information
Observations |
Control |
Sodium Capryl Lactylate (2%) |
Litters per group |
19/19 |
19/20 |
Total live pups |
|
|
Birth |
221 |
212 |
Day 5 |
127 |
108 |
Weaning |
81 |
74 |
Total Stillborn |
1 |
2 |
Live pups per litter |
11.6 |
11.2 |
Per cent survival at day 5 |
57.5 |
50.9 |
100X weaning survival/ 5 day survival |
68.6 |
71.9 |
Mean body weights (g) of live pups at |
|
|
Birth |
5.96 |
6.10 |
Day 5 |
7.43 |
7.69 |
Weaning |
33.9 |
34.0 |
F2B Litter Information
Observations |
Control |
Sodium Capryl Lactylate (2%) |
Litters per group |
17/19 |
20/20 |
Total live pups |
|
|
Birth |
210 |
233 |
Day 5 |
97 |
89 |
Weaning |
63 |
68 |
Total Stillborn |
0 |
1 |
Live pups per litter |
12.4 |
11.6 |
Per cent survival at day 5 |
46.2 |
38.2 |
100X weaning survival/ 5 day survival |
72.4 |
78.2 |
Mean body weights (g) of live pups at |
|
|
Birth |
5.91 |
5.91 |
Day 5 |
8.34 |
77.76 |
Weaning |
39.5 |
32.0 |
F3A Litter Information
Observations |
Control |
Sodium Capryl Lactylate (2%) |
Litters per group |
14/20 |
18/20 |
Total live pups |
|
|
Birth |
143 |
199 |
Day 5 |
82 |
164 |
Weaning |
68 |
147 |
Total Stillborn |
0 |
1 |
Live pups per litter |
10.2 |
11.1 |
Per cent survival at day 5 |
57.6 |
82.4 |
100X weaning survival/ 5 day survival |
82.9 |
89.6 |
Mean body weights (g) of live pups at |
|
|
Birth |
5.73 |
5.72 |
Day 5 |
8.89 |
8.57 |
Weaning |
37.5 |
33.1 |
F3B Litter Information
Observations |
Control |
Sodium Capryl Lactylate (2%) |
Litters per group |
16/20 |
17/20 |
Total live pups |
|
|
Birth |
167 |
198 |
Day 5 |
115 |
123 |
Weaning |
101 |
97 |
Total Stillborn |
1 |
1 |
Live pups per litter |
11.1 |
11.6 |
Per cent survival at day 5 |
68.9 |
62.1 |
100X weaning survival/ 5 day survival |
87.8 |
78.6 |
Mean body weights (g) of live pups at |
|
|
Birth |
6.03 |
5.90 |
Day 5 |
9.76 |
8.20 |
Weaning |
36.7 |
33.4 |
Applicant's summary and conclusion
- Conclusions:
- There were no differences among control group and those fed sodium capryl lactylate that could be ascribed to treatment. Mortality, body weights, food intake, gross necropsy (gonad weights) and litter data were collected. Sodium capryl lactylate does not adversely effect development in albino rats through three generations.
- Executive summary:
A three-generation reproductive study in albino Sprague-Dawley Rats was performed on the test substance sodium capryl lactylate. Mortality, body weights, food intake, gross necropsy (gonad weights) and litter data were collected. There were no differences among control group and those fed sodium capryl lactylate that could be ascribed to treatment. The author noted there was a questionable significance of cortical cyst incidence in the kidneys of females. Sodium capryl lactylate does not adversely affect development in albino rats through three generations.
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