Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 266-533-8 | CAS number: 66988-04-3
- 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
Sodium stearoyl lactylate (SSL), calcium stearoyl lactylate (CSL) and stearic acid (a key metabolite of SSL and CSL) were used as read-across substances for the test item sodium isostearoyl lactylate. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
In a three-generation reproductive toxicity study, oral feeding of 20000 ppm SSL to albino rats did not elicit reproductive effects. Further scientific understanding of the toxicokinetics and metabolism of CSL (see IUCLID section 7.1) reveals there is rapid enzymatic cleavage of calcium stearoyl lactylate (in the liver and intestinal mucosa) to stearic acid upon oral exposure, eventually resulting to excreted products such as CO2 (in exhaled air; 75 - 80 % excreted within the first 24 h) as well as lactic acid (in urine). As mentioned in the OECD SIDS assessment report for aliphatic (fatty) acids, which includes stearic acid in the evaluation, no effects on fertility or on reproductive organs were observed in studies on the aliphatic acids and demonstrate the lack of reproductive toxicity concern of these acids.
Given the existing animal data and understanding of the metabolism and effects on the read-across substances, there is no reproductive toxicity concern of sodium isostearoyl lactylate taking a weight-of-evidence approach.
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:
- The source compound sodium stearoyl lactylate (CAS 25383-99-7) is considered a suitable read-across partner for the target substance sodium isostearoyl lactylate (EC # 266-533-8, CAS # 66988-04-3). This read-across is based on the hypothesis that source and target substances have similar toxicological properties because of:
- structural similarity of the target and the source substances (long fatty acid chain with lactylate group)
- similarity in metabolic pathway (rapid hydrolysis and enzymatic cleavage of the ester bond resulting in the fatty acid chain and lactylate group, which get further metabolised to yield lactate and subsequently carbon dioxide; the fatty acid is metabolised to carbon dioxide via beta-oxidation).
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 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.
- 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
- 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):
- 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:
- other: no adverse effects observed
- Critical effects observed:
- no
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One control female died during the study on day 22 of gestation, having begun labor in very poor condition with wheezing and low body temperature.
An additional control was sacrificed in poor condition during week 23. This animal had born an F2a litter but did not conceive the second time.
Otherwise, the F1b rats were in a good condition. - Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One control female died during the study on day 22 of gestation.
An additional control was sacrificed in poor condition during week 23. This animal had born an F2a litter but did not conceive the second time. - 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 92-101 % compared to 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):
- Mean testis and ovary weights of the treatment group were comparable to the control group.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At necropsy ten male and female P1 animals contained kidney, liver and lung anomalies but these were neither consistent, frequent, or difference enough for control animals to show test material relationship.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Details on results:
- Visceral findings showed nothing that could be related to dietary level of sodium stearoyl lactylate. Calculations that give the percentages of F1a pups which had zero, one, two or three or more anomalies per pup indicate no meaningful differences between the groups.
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Implantation sites of the treatment group were comparable to the control group. 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
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
- Critical effects observed:
- no
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In one animal of the control group respiratory disease was observed. This animal died between week 16 and 18. Otherwise the F2b rats were in a good condition.
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- One male from the control group died during the study. The death was attributed to respiratory disease.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Mean body weights of F2a and F2b pups at day 5 and at weaning were on par with control weights. Pups of the treatment group weighed 79% of the control weight.
- 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 testis and ovary weights between treated and control groups were comparable.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Gross autopsy findings in F2b females were confined chiefly to lung abscesses in one female. Except for the testis weights, gross observations on the males were not made.
- Histopathological findings:
- not examined
- Other effects:
- not specified
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 20 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
- 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:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At week 20, the males and females receiving the material in the diet weighed 93 to 106 % of the controls.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No significant differences were noted.
- 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:
- no effects observed
- 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:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No significant differences were shown between control and test rats. Five females showed lung and liver abnormalities and males were not observed. These are not considered different from abnormalities in controls.
- Histopathological findings:
- not examined
- Other effects:
- not examined
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 20 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- There were no differences among control group and those fed sodium stearoyl lactylate that could be ascribed to treatment. Sodium stearoyl lactylate does not adversely effect reproduction in albino rats through three generations.
- Executive summary:
In a three-generation reproduction study, sodium stearoyl lactylate was administered to 20 male and female Sprague-Dawley rats at dose levels of 0 and 20000 ppm in diet. The animals were placed on compound no later than one week after weaning. Original parent rats (F0 generation) were bred twice; the F1a pups were sacrificed at birth and part of each litter was examined either for skeletal abnormalities (cleared, stained specimens) or for visceral changes (Bouin’s fixative specimens). 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 (F3a and F3b). Mortality, body weights, food intake, gross necropsy (gonad weights) and litter data were determined. There were no differences among the control group and those fed sodium stearoyl lactylate that could be ascribed to treatment. Sodium stearoyl 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 attached to IUCLID section 13.
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- other: assessment report
- Adequacy of study:
- supporting 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
- Conclusions:
- No effects on fertility or on reproductive organs (observed in tests similar to OECD guideline 408 or 422) were observed in studies on a number of aliphatic fatty acids (including unsaturated aliphatic acids) at the highest doses tested. The weight of evidence supports the lack of reproductive toxicity potential of the aliphatic acids category including stearic acid (a key metabolite of sodium or calcium stearoyl lactylate).
- Executive summary:
In an OECD 2014 SIDS assessment report on the aliphatic acids category, which includes stearic acid (CAS # 57-11-4), a key metabolite of sodium or calcium stearoyl lactylate, as part of its evaluation, it is mentioned that no effects on fertility or on reproductive organs (observed in tests similar to OECD guideline 408 or 422)were observed in studies on a number of aliphatic acids, including docosanoic acid as well as unsaturated aliphatic acids such as 9-octadecenoic acid and 9,12-octadecadienoic acid, and the NOAELs of these studies correspond to the maximum doses tested. For the evaluation of the reproductive toxicity potential of stearic acid, docosanoic acid was used as read-across partner, which has a NOAEL for reproductive toxicity of 1000 mg/kg body weight per day (the highest dose tested). It was concluded in this report that the weight-of-evidence supports the lack of reproductive toxicity potential of the aliphatic acids category including stearic acid.
The 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.
Referenceopen allclose all
There was slightly lower survival at five and twenty-one days in all litters which was believed to be happenstance.
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 stearoyl lactylate under the conditions of this study.
The full tables of litter data for each generation are below.
F1A Litter Information
Observations |
Control |
Sodium Stearoyl Lactylate (2%) |
Litters per group |
18/20 |
16/20 |
Total live pups |
207 |
178 |
Total Stillborn |
1 |
0 |
Live pups per litter |
11.5 |
11.1 |
Mean body weights (g) of live pups |
5.53 |
5.94 |
Number of male pups |
109 |
84 |
Number of female pups |
98 |
94 |
F1B Litter Information
Observations |
Control |
Sodium Stearoyl Lactylate (2%) |
Litters per group |
12/20 |
18/20 |
Total live pups |
|
|
Birth |
151 |
221 |
Day 5 |
96 |
128 |
Weaning |
79 |
106 |
Total Stillborn |
0 |
0 |
Live pups per litter |
12.6 |
12.3 |
Per cent survival at day 5 |
63.6 |
58.0 |
100x weaning survival/ 5 day survival |
86.8 |
87.6 |
Mean body weights (g) of live pups at |
|
|
Birth |
5.90 |
6.14 |
Day 5 |
9.65 |
9.08 |
Weaning |
41.5 |
37.7 |
F2A Litter Information
Observations |
Control |
Sodium Stearoyl Lactylate (2%) |
Litters per group |
19/19 |
17/20 |
Total live pups |
|
|
Birth |
221 |
196 |
Day 5 |
127 |
116 |
Weaning |
81 |
58 |
Total Stillborn |
1 |
2 |
Live pups per litter |
11.6 |
11.5 |
Per cent survival at day 5 |
57.5 |
59.2 |
100x weaning survival/ 5 day survival |
68.6 |
55.2 |
Mean body weights (g) of live pups at |
|
|
Birth |
5.96 |
6.18 |
Day 5 |
7.43 |
7.50 |
Weaning |
33.9 |
33.8 |
F2B Litter Information
Observations |
Control |
Sodium Stearoyl Lactylate (2%) |
Litters per group |
17/19 |
19/20 |
Total live pups |
|
|
Birth |
210 |
219 |
Day 5 |
97 |
67 |
Weaning |
63 |
55 |
Total Stillborn |
0 |
1 |
Live pups per litter |
12.4 |
11.5 |
Per cent survival at day 5 |
46.2 |
30.6 |
100x weaning survival/ 5 day survival |
72.4 |
82.2 |
Mean body weights (g) of live pups at |
|
|
Birth |
5.91 |
6.08 |
Day 5 |
8.34 |
7.63 |
Weaning |
39.5 |
31.1 |
F3A Litter Information
Observations |
Control |
Sodium Stearoyl Lactylate (2%) |
Litters per group |
14/20 |
18/20 |
Total live pups |
|
|
Birth |
143 |
193 |
Day 5 |
82 |
123 |
Weaning |
68 |
113 |
Total Stillborn |
0 |
0 |
Live pups per litter |
10.2 |
10.2 |
Per cent survival at day 5 |
57.6 |
63.7 |
100x weaning survival/ 5 day survival |
82.9 |
91.9 |
Mean body weights (g) of live pups at |
|
|
Birth |
5.73 |
5.87 |
Day 5 |
8.89 |
9.46 |
Weaning |
37.5 |
33.5 |
F3B Litter Information
Observations |
Control |
Sodium Stearoyl Lactylate (2%) |
Litters per group |
16/20 |
17/20 |
Total live pups |
|
|
Birth |
167 |
194 |
Day 5 |
115 |
138 |
Weaning |
101 |
127 |
Total Stillborn |
1 |
0 |
Live pups per litter |
11.1 |
11.4 |
Per cent survival at day 5 |
68.9 |
71.1 |
100x weaning survival/ 5 day survival |
87.8 |
92.0 |
Mean body weights (g) of live pups at |
|
|
Birth |
6.03 |
6.20 |
Day 5 |
9.76 |
10.1 |
Weaning |
36.7 |
36.4 |
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
Sodium stearoyl lactylate (SSL), calcium stearoyl lactylate (CSL) and stearic acid (a key metabolite of SSL and CSL) were used as read-across substances for the test item sodium isostearoyl lactylate. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.
In a three-generation reproductive toxicity study, oral feeding of 20000 ppm SSL to albino rats did not elicit developmental effects. Further scientific understanding of the toxicokinetics and metabolism of CSL (see IUCLID section 7.1) reveals there is rapid enzymatic cleavage of CSL (in the liver and intestinal mucosa) to stearic acid upon oral exposure, eventually resulting to excreted products such as CO2 (in exhaled air; 75 - 80 % excreted within the first 24 h) as well as lactic acid (in urine). As mentioned in the OECD SIDS assessment report for aliphatic (fatty) acids, which include stearic acid in the evaluation, no effects on developmental effects were observed in studies on the aliphatic acids and demonstrate the lack of reproductive toxicity concern of these acids.
Given the existing animal data and understanding of the metabolism and effects on the read-across substances, there is no developmental toxicity concern of sodium isostearoyl lactylate taking a weight-of-evidence approach.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reason / purpose for cross-reference:
- read-across source
- Conclusions:
- No effects on developmental effects (observed in tests performed in accordance or similar to OECD Guideline 422 or 416) were observed in studies on a number of aliphatic acids (including unsaturated aliphatic acids) at the highest doses tested. The weight of evidence supports the lack of developmental toxicity potential of the aliphatic acids category including stearic acid (a key metabolite of sodium or calcium stearoyl lactylate).
- Executive summary:
In an OECD 2014 SIDS assessment report on the aliphatic fatty acids category, which includes stearic acid (CAS 57-11-4), a key metabolite of sodium or calcium stearoyl lactylate, as part of its evaluation, it is mentioned that no effects on developmental endpoints (observed in tests performed in accordance or similar to OECD guideline 422 or 416) were observed in studies on a number of aliphatic acids, including 9,12-octadecadienoic acid and docosanoic acid, and the NOAELs of these studies correspond to the maximum dose tested. For the evaluation of developmental effects of stearic acid, docosanoic acid was used as read-across, which has a NOAEL for developmental toxicity of 1000 mg/kg body weight per day (the highest dose tested). Overall, it was concluded in this report that the weight of evidence supports the lack of developmental toxicity potential of the aliphatic acids category including stearic acid.
The 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.
- 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:
- The source compound sodium stearoyl lactylate (CAS 25383-99-7) is considered a suitable read-across partner for the target substance sodium isostearoyl lactylate (EC # 266-533-8, CAS # 66988-04-3). This read-across is based on the hypothesis that source and target substances have similar toxicological properties because of:
- structural similarity of the target and the source substances (long fatty acid chain with lactylate group)
- similarity in metabolic pathway (rapid hydrolysis and enzymatic cleavage of the ester bond resulting in the fatty acid chain and lactylate group, which get further metabolised to yield lactate and subsequently carbon dioxide; the fatty acid is metabolised to carbon dioxide via beta-oxidation).
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
- Specific details on test material used for the study:
- - Appearance: off-white powder
SOURCE OF TEST MATERIAL
- Source and lot/batch no.of test material:
23 E 299 - Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In the P1 generation, One control female died during the study on day 22 of gestation, having begun labor in very poor condition with wheezing and low body temperature. An additional control was sacrificed in poor condition during week 23. This animal had born an F2a litter but did not conceive the second time.
In one F1 animal of the control group respiratory disease was observed. This animal died between week 16 and 18.
All other rats were in good condition throughout. - Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- All P0 rats survived their portion of the study.
In the P1 generation, one control female died during the study on day 22 of gestation. An additional control was sacrificed in poor condition during week 23. This animal had born a litter but did not conceive the second time.
One F1 male from the control group died during the study. The death was attributed to respiratory disease. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant changes in body weights were observed.
- 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.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- At necropsy the P0 parents showed no gross abnormalities.
Ten male and female P1 animals contained kidney, liver and lung anomalies but these were neither consistent, frequent, or difference enough for control animals to show test material relationship.
Gross autopsy findings in F1 females were confined chiefly to lung abscesses in one female. Except for the testis weights, gross observations on the males were not made.
For F2, no significant differences were shown between control and test rats. Five females showed lung and liver abnormalities and males were not observed. These are not considered different from abnormalities in controls. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- None of the histopathological findings were to be ascribed to administration of sodium steariyk lactylate.
- 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:
- effects observed, non-treatment-related
- 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 were 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.
- Dose descriptor:
- NOAEL
- Effect level:
- 20 000 ppm
- Basis for effect level:
- other: no effects observed
- 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:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Pups from the F1 generation were 79% of control weight and those in the F2 generation were 93% of the weight.
- 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.
- Dose descriptor:
- NOEL
- Effect level:
- 20 000 ppm
- Basis for effect level:
- other: no effects observed
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- Conclusions:
- There were no differences among control group and those fed sodium stearoyl lactylate that could be ascribed to treatment. Sodium stearoyl lactylate does not adversely affect development in albino rats through three generations.
- Executive summary:
In a three-generation reproduction study, sodium stearoyl lactylate was administered to 20 male and female Sprague-Dawley rats at dose levels of 0 and 20000 ppm in diet. The animals were placed on compound no later than one week after weaning. Original parent rats (F0 generation) were bred twice; the F1a pups were sacrificed at birth and part of each litter was examined either for skeletal abnormalities (cleared, stained specimens) or for visceral changes (Bouin’s fixative specimens). 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 (F3a and F3b). Mortality, body weights, food intake, gross necropsy (gonad weights) and litter data were determined. There were no differences among the control group and those fed sodium stearoyl lactylate that could be ascribed to treatment. Sodium stearoyl 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.
Referenceopen allclose all
The full tables of litter data for each generation are below.
F1A Litter Information
Observations |
Control |
Sodium Stearoyl Lactylate (2%) |
Litters per group |
18/20 |
16/20 |
Total live pups |
207 |
178 |
Total Stillborn |
1 |
0 |
Live pups per litter |
11.5 |
11.1 |
Mean body weights (g) of live pups |
5.53 |
5.94 |
Number of male pups |
109 |
84 |
Number of female pups |
98 |
94 |
F1B Litter Information
Observations |
Control |
Sodium Stearoyl Lactylate (2%) |
Litters per group |
12/20 |
18/20 |
Total live pups |
|
|
Birth |
151 |
221 |
Day 5 |
96 |
128 |
Weaning |
79 |
106 |
Total Stillborn |
0 |
0 |
Live pups per litter |
12.6 |
12.3 |
Per cent survival at day 5 |
63.6 |
58.0 |
100x weaning survival/ 5 day survival |
86.8 |
87.6 |
Mean body weights (g) of live pups at |
|
|
Birth |
5.90 |
6.14 |
Day 5 |
9.65 |
9.08 |
Weaning |
41.5 |
37.7 |
F2A Litter Information
Observations |
Control |
Sodium Stearoyl Lactylate (2%) |
Litters per group |
19/19 |
17/20 |
Total live pups |
|
|
Birth |
221 |
196 |
Day 5 |
127 |
116 |
Weaning |
81 |
58 |
Total Stillborn |
1 |
2 |
Live pups per litter |
11.6 |
11.5 |
Per cent survival at day 5 |
57.5 |
59.2 |
100x weaning survival/ 5 day survival |
68.6 |
55.2 |
Mean body weights (g) of live pups at |
|
|
Birth |
5.96 |
6.18 |
Day 5 |
7.43 |
7.50 |
Weaning |
33.9 |
33.8 |
F2B Litter Information
Observations |
Control |
Sodium Stearoyl Lactylate (2%) |
Litters per group |
17/19 |
19/20 |
Total live pups |
|
|
Birth |
210 |
219 |
Day 5 |
97 |
67 |
Weaning |
63 |
55 |
Total Stillborn |
0 |
1 |
Live pups per litter |
12.4 |
11.5 |
Per cent survival at day 5 |
46.2 |
30.6 |
100x weaning survival/ 5 day survival |
72.4 |
82.2 |
Mean body weights (g) of live pups at |
|
|
Birth |
5.91 |
6.08 |
Day 5 |
8.34 |
7.63 |
Weaning |
39.5 |
31.1 |
F3A Litter Information
Observations |
Control |
Sodium Stearoyl Lactylate (2%) |
Litters per group |
14/20 |
18/20 |
Total live pups |
|
|
Birth |
143 |
193 |
Day 5 |
82 |
123 |
Weaning |
68 |
113 |
Total Stillborn |
0 |
0 |
Live pups per litter |
10.2 |
10.2 |
Per cent survival at day 5 |
57.6 |
63.7 |
100x weaning survival/ 5 day survival |
82.9 |
91.9 |
Mean body weights (g) of live pups at |
|
|
Birth |
5.73 |
5.87 |
Day 5 |
8.89 |
9.46 |
Weaning |
37.5 |
33.5 |
F3B Litter Information
Observations |
Control |
Sodium Stearoyl Lactylate (2%) |
Litters per group |
16/20 |
17/20 |
Total live pups |
|
|
Birth |
167 |
194 |
Day 5 |
115 |
138 |
Weaning |
101 |
127 |
Total Stillborn |
1 |
0 |
Live pups per litter |
11.1 |
11.4 |
Per cent survival at day 5 |
68.9 |
71.1 |
100x weaning survival/ 5 day survival |
87.8 |
92.0 |
Mean body weights (g) of live pups at |
|
|
Birth |
6.03 |
6.20 |
Day 5 |
9.76 |
10.1 |
Weaning |
36.7 |
36.4 |
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
Given the existing animal data as well as the understanding of the metabolism and effects on the read-across substances, there is no reproductive or developmental toxicity concern of sodium isostearoyl lactylate taking a weight-of-evidence approach. No classification of sodium isostearoyl lactylate for reproductive or developmental toxicity is thus warranted.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.