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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
Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive 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 available
- 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
- Limit test:
- no
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 species / strain selection:
- albino
- Sex:
- male/female
- 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:
- 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
- Details on study schedule:
- 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.
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
- Positive control:
- none
Examinations
- Parental animals: Observations and examinations:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly, Time of sacrifice
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Mean weekly food intake measured- Oestrous cyclicity (parental animals):
- Not mentioned
- Sperm parameters (parental animals):
- Not mentioned
- Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in all offspring:
number and sex of pups, stillbirths, live births, presence of gross anomalies, weight gain
GROSS EXAMINATION OF DEAD PUPS:
Yes - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals after offspring weaned.
- Maternal animals: All surviving animals after offspring weaned.
GROSS NECROPSY
- Gross necropsy consisted of gonad weights and litter data.
HISTOPATHOLOGY / ORGAN WEIGHTS
Gonad weights - Postmortem examinations (offspring):
GROSS NECROPSY
- Gross necropsy consisted of gonad weights and litter data.
HISTOPATHOLOGY / ORGAN WEIGHTS
- Gonad weights (i.e. testes in males and ovary in females) in all parent and foetal generations
- Heart, liver and kidney weights of F3 generations (occurred two days after weaning of F3 pups)
- Histopathology of F3 generations- Statistics:
- not specified
- Reproductive indices:
- Testis weights in males
Ovary weights and implantation sites in females
Days of gestation - Offspring viability indices:
- Numbe rof live/dead pups per litter
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- All P0 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 P0 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):
At 19-20 weeks of study the treated P0 rats of either sex weighed 94-99% as much as the controls.- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- The mean food consumption paralleled body weights.
- 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
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- The uterine implantation sites between treated and control female rats were comparable to one another. There was no significant differences observed in the number of gestation days between control (range of 21-22 days) and treated (range of 21 to 24 days) dams.
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- 20 000 ppm
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
- reproductive performance
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- All P1 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 P1 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):
- At week 22 the males and females receiving the material in the diet weighed 91 and 103 per cent as much, respectively, as the controls.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumptions figures for the two groups were closely similar throughout the experiment.
- 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 the P1 parents showed no gross abnormalities.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Mean testis and ovary weights and mean total uterine implantation sites were respectively comparable among the groups. No meaningful discrepancies between total numbers of implantation sites and total numbers of pups per dam were found.
Effect levels (P1)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 20 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
- reproductive performance
Target system / organ toxicity (P1)
- Key result
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Slightly lower survival at five and twenty-one days which is believed to be happenstance, and the fact the survival at weaning in this group was somewhat superior to control weanling survival also indicates that compound feeding was not responsible.
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- Slightly lower survival at five and twenty-one days which is believed to be happenstance, and the fact the survival at weaning in this group was somewhat superior to control weanling survival also indicates that compound feeding was not responsible.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- At week 22 the males and females receiving the material in the diet weighed 91 and 103 per cent as much, respectively, as the controls.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumptions figures for the two groups were closely similar throughout the experiment.
- 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:
- 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 the F1 generation showed no gross abnormalities. Skeletal and visceral anomalies in sacrificed pups were not in frequencies high enough to be meaningful.
- Histopathological findings:
- not examined
- Other effects:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 20 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- The F2 generation rats were in good condition. Slightly lower survival at five and twenty-one days which is believed to be because of an intercurrent infection of undetermined nature.
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- Slightly lower survival at five and twenty-one days which is believed to be because of an intercurrent infection of undetermined nature.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- At week 20 the males and females receiving the material in the diet weighed 93 to 99 per cent as much, respectively, as the controls.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No significant differences were noted for food consumption.
- 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:
- 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):
- No significant differences were shown between control and test rats. Stillborn pups examined in the group that received test material were grossly normal. Pups that died by day 5 and were in condition suitable for examination were also found to be grossly normal.
- Histopathological findings:
- not examined
- Other effects:
- not examined
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not examined
Effect levels (F2)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 20 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
Target system / organ toxicity (F2)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Any other information on results incl. tables
There were no other significant differences or effects observed for mortality, body weights, food intake, gross necropsy (gonad weights) in either of the P2 or F3 generations.
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. Sodium stearoyl lactylate does not adversely effect reproduction in albino rats through three generations. The author noted there was a questionable significance of cortical cyst incidence in the kidneys of females.
- 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 F3 females. Sodium capryl lactylate does not adversely effect reproduction in albino rats through three generations.
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