Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl laurate

Endpoint summary

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

Reference

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

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

 

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.

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

Reference

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

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

 

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.

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.