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

Endpoint summary

Description of key information

The available studies on test item sodium lauroyl lactylate, its metabolite (lauric acid) as well as its read-across substances (sodium stearoyl lactylate and sodium isostearoyl lactylate) have all shown no acute oral toxicity concern. The oral LD₅₀ values of sodium isostearoyl lactylate (Pationic ISL) and sodium stearoyl lactylate were determined to be greater than 6100 mg/kg bw and 5000 mg/kg, respectively, in male albino rats. Furthermore, supporting information has shown that 10% concentration of sodium lauroyl lactylate and lauric acid have reported acute oral LD₅₀ values of 6810 mg/kg bw and 12000 mg/kg bw, respectively, in rats. Altogether, by way of read-across and taking a weight-of-evidence approach, sodium lauroyl lactylate is not acutely toxic via the oral route.

Acute dermal toxicity testing is not necessary as the substance is classified as corrosive to the skin, and acute inhalation toxicity testing is not necessary due to lack of exposure potential (very low vapour pressure, amorphous solid with no potential for dust or aerosol generation). In conclusion, sodium lauroyl lactylate is not known to be acutely toxic via any route of administration.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 6 100 mg/kg bw

Based on:

test mat.

Mortality:

Four mortalities (out of ten tested rats) occurred during the study with no signs of toxicity were noted in these rats prior to death. Three rats died within 5.5 hours following dosage. One rat was found dead on Day 1.

Clinical signs:

other: - For the rats that died before the study ended, no clinical signs of toxicity were noted prior to death. - Toxic signs in the survivors during the remainder of the day of dosage included depression in five rats and depressed righting and placement reflex

Gross pathology:

- Gross necropsies performed on the 3 rats that died 5.5 h following dosage revealed congested lungs and fluid in the pleural cavity in all the rats, congested adrenals in one rat and irritated intestinal tracts with a creamy yellow semi-solid in the stomach of two rats.
- Of the one rat that died on Day 1 of dosage, the lungs were congested and the pleural cavity was filled with bloody appearing fluid. The kidneys were congested. The gastrointestinal tract was irritated, the stomach was filled with a yellow semi-solid and the peritoneal wall was wrinkled as well as advanced autolysis was noted. External urine stains were also observed.
- Necropsies performed at study termination of the surviving rats revealed no significant gross pathological alterations.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of sodium isostearoyl lactylate (Pationic ISL) was determined in this study to be greater than 6.1 g / kg bw for male rats.

Executive summary:

In an acute toxicity study, 10 male Sprague-Dawley derived albino rats were exposed orally to a single dose of sodium isostearoyl lactylate (Pationic ISL) at 6.1 g/kg body weight via a stomach tube. Clinical observations were observed daily up to 14 days after dosage, when the animals were sacrificed and necropsies were performed. Clinical signs included depression and minor behavioural and respiratory effects and four mortalities (out of the 10 tested rats) were observed during the study. Based on these results, the acute oral LD₅₀of sodium isostearoyl lactylate (Pationic ISL) was determined to be greater than 6.1 g / kg bw for male rats.

This information is used in a read-across approach in the assessment of the target substance. For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Limit test:

yes

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred following dosage of sodium stearoyl lactylate to a group of male albino rats at a dosage level of 5 g/kg body weight.

Clinical signs:

other: Signs of toxicity observed on the day of dosage were confined to mucoid diarrhea and stains in two of the rats. All the rats appeared normal on the first post-dosage day and through day six. Three rats on day seven exhibited diarrhea stains for one to fou

Gross pathology:

Necropsies performed at termination revealed no gross pathological alterations.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of sodium stearoyl lactylate was found to be greater than 5 g/kg body weight for male albino rats.

Executive summary:

In an acute toxicity study, 10 male albino rats were given a single oral dose of sodium stearoyl lactylate in distilled water at the dose level of 5 g/kg body weight via a stomach tube. Animals were observed for 14 days, when the animals were sacrificed and necropsies were performed. No mortality or gross pathological alterations were observed in the rats at the end of the study. Signs of toxicity were only limited to diarrhea stains, and rats exhibited normal appearance and behaviour through termination of the study. Based on these results, the acute oral LD₅₀ of the sodium stearoyl lactylate was found to be greater than 5 g/kg bw for male albino rats.

This information is used in a read-across approach in the assessment of the target substance.For details and justification of read-across please refer to the read-across report attached to IUCLID section 13.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

6 100 mg/kg bw

Quality of whole database:

Study performed in accordance with the techniques specified in the US Regulations for the Enforcement of the Federal Hazardous Substances Act (Code of Federal Regulations, Title 16 Chapter II, 1976).

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as corrosive to the skin

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In an acute toxicity study, 10 male Sprague-Dawley derived albino rats were exposed orally to a single dose of sodium isostearoyl lactylate (Pationic ISL) at 6.1 g/kg body weight via a stomach tube. Clinical observations were observed daily up to 14 days after dosage, when the animals were sacrificed and necropsies were performed. Clinical signs included depression and minor behavioural and respiratory effects and four mortalities (out of the 10 tested rats) were observed during the study. Based on these results, the acute oral LD₅₀ of sodium isostearoyl lactylate (Pationic ISL) was determined to be greater than 6.1 g/kg bw for male rats.

In an acute toxicity study, 10 male albino rats were given a single oral dose of sodium stearoyl lactylate in distilled water at the dose level of 5 g/kg body weight via a stomach tube. Animals were observed for 14 days, when the animals were sacrificed and necropsies were performed. No mortality or gross pathological alterations were observed in the rats at the end of the study. Signs of toxicity were only limited to diarrhea stains, and rats exhibited normal appearance and behaviour through termination of the study. Based on these results, the acute oral LD₅₀ of the sodium stearoyl lactylate was found to be greater than 5 g/kg bw for male albino rats.

Supporting information has shown that 10% concentration of sodium lauroyl lactylate and lauric acid have reported acute oral LD₅₀values of 6810 mg/kg bw and 12000 mg/kg bw, respectively, in rats.

In accordance with column 2 of section 8.5 of REACH Annex VIII, acute dermal toxicity testing does not need to be conducted because the test substance is classified as corrosive to the skin.

In accordance with column 2 of REACH Annex VIII, substances other than gases shall be tested through one more route except for the oral for acute toxicity (inhalation or dermal). The choice for the second route shall depend on the nature of the substance and the likely route of human exposure. The dermal route, next to the oral, was considered more appropriate for sodium lauroyl lactylate since inhalation is unlikely, and therefore, the requirement for acute inhalation toxicity is waived.

Justification for classification or non-classification

Sodium lauroyl lactylate does not warrant classification for acute toxicity based on the results of the read-across substances sodium isostearoyl lactylate and sodium stearoyl lactylate, which indicate acute oral LD₅₀ values above the limit value for classification of 2000 mg/kg bw.