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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
There were no differences among control group and those fed sodium capryl lactylate that could be ascribed to treatment. Sodium capryl lactylate does not adversely effect reproduction in albino rats through three generations. By way of read-across, this conclusion is also valid for the target substance sodium lauroyl lactylate.
Link to relevant study records
- Endpoint:
- three-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For justification of read-across please refer to the read-across report attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- 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: 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.
- 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
- water consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
- reproductive performance
- Key result
- Critical effects observed:
- no
- 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 examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- 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.
- 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
- Key result
- Critical effects observed:
- no
- 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
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- 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
- Key result
- Critical effects observed:
- no
- 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
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- 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
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- 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 effect reproduction 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 F3 females. Sodium capryl lactylate does not adversely affect reproduction in albino rats through three generations.
This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the read-across report This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the attached read-across report attached to IUCLID section 13.
Reference
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 |
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
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. By way of read-across, this conclusion is also valid for the target substance sodium lauroyl lactylate.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For justification of read-across please refer to the read-across attached to IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- 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):
- Cortical cyst incidence was higher in the kidneys of females who received treatment.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- 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
- 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
- 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
- Key result
- Abnormalities:
- no effects observed
- 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:
- no effects observed
- 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:
- no effects observed
- 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.
- 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
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- 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.
This information is used in a read-across approach in the assessment of the target substance. For justification of read-across please refer to the read-across report attached to IUCLID section 13.
Reference
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 |
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Neither reproductive nor developmental effects were detected in an oral three-generation study on sodium capryl lactylate. By way of read-across, these results are also valid for the structurally related target substance sodium lauroyl lactylate. Therefore, classification for reproductive toxicity is not warranted.
Additional information
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