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Description of key information

The oral LD50 of sodium isostearoyl lactylate (Pationic ISL) was determined to be greater than 6100 mg/kg bw in Sprague-Dawley rats. Therefore, sodium isostearoyl lactylate is not acutely toxic.

Acute dermal toxicity testing is not necessary due to lack of oral toxicity. Finally, acute inhalation toxicity testing is not necessary due to lack of exposure potential (very low vapour pressure, viscous liquid with no potential for aerosol generation).

In conclusion sodium isostearoyl lactylate is not acutely toxic via any route of administration.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977-08-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
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).
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Test material name: Pationic ISL
- Source: C.J. Patterson Company
- Appearance: Thick clear yellow liquid with a slight odor
- Batch No. : Pl 06 24 77
Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Industries, Inc.
- Females (if applicable) nulliparous and non-pregnant: Not applicable
- Weight at study initiation: 213–250 g
- Fasting period before study: 18 h
- Housing: Rtas were housed in groups in wire mesh cages suspended above droppings
- Diet (e.g. ad libitum): Yes
- Water (e.g. ad libitum): Yes
Route of administration:
other: via stomach tube
Vehicle:
unchanged (no vehicle)
Doses:
6.1 g/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: At frequent intervals during the day of dosage and atleast once thereafter for a total of 14 days
- Necropsy of survivors performed: Yes
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:
- 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 reflexes and laboured respiration in one rat.
- All survivors appeared normal on the first post-dosage day.
- From the second day, the survivors exhibited normal appearance and behaviour throughout the study with the exception of two rats with urine stains noted on day 3 and one to two rats with diarrhea noted on days 8, 9 and 10.
Body weight:
- The average body weight gain for the surviving rats was 111 g. This gain is normal for the rats of the age, sex and strain used in this study.
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 LD50 of sodium isostearoyl lactylate was found to be greater than 6.1 g/kg bw in rats.
Executive summary:

In an acute toxicity study, 10 male Sprague-Dawley rats were administere orally sodium isostearoyl lactylate (Pationic ISL) via a stomach tube for 14 days. Clinical observations and body weights were recorded and necropsies were performed. Clinical signs included depression and minor behavioural and respiratory effects. Four mortalities (out of the 10 tested rats) were observed during the study. Based on these results, the LD50 of sodium isostearoyl lactylate in rats was determined to be greater than 6.1 g/kg bw.

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), i.e. similar to OECD guideline 401.

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 does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Conclusions:
In accordance with Column 2 of Section 8.5.3 of REACH Annex VIII, acute dermal toxicity testing does not need to be conducted because the substance does not meet the criteria for classification for acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure.
Executive summary:

In accordance with Column 2 of Section 8.5.3 of REACH Annex VIII, acute dermal toxicity testing does not need to be conducted because the substance does not meet the criteria for classification for acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure.

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In an acute toxicity study, 10 male, Sprague-Dawley rats were exposed orally to the test substance sodium isostearoyl lactylate (Pationic ISL) via a stomach tube for 14 days. Clinical observations and body weights were recorded 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 LD50 of the test substance in rats was determined to be greater than 6.1 g/kg bw.

In accordance with column 2 of Section 8.5.3 of REACH Annex VIII, acute dermal toxicity testing does not need to be conducted because the test substance does not meet the criteria for classification for acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure.

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 isostearoyl lactylate, since inhalation is unlikely, and therefore the requirement for acute inhalation toxicity is waived.

Justification for classification or non-classification

Based on the available data, sodium isostearoyl lactylate does not warrant classification for acute toxicity. The LD50 value for the oral route is above the limit value for classification of 2000 mg/kg bw, and there is no indication of systemic effects upon dermal exposure.

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