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Administrative data

Description of key information

OECD 401/OECD 402, conducted with a similar substance. Both tests were conducted at a limit dose of 2000 mg/kg bw. None of the test animals died or showed sublethal effects. 
As no data are available for CAS 91744-39-7 (Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts), the available data for the analogue substance CAS 91744-23-9 are used in a read-across approach. For details please refer to the read-across report.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
GLP guideline study. Reliable with restriction.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
GLP guideline study. Reliable with restriction.

Additional information

No data are available for Glycerides, C16 -18 mono-, di- and tri-, hydrogenated, citrates. Therefore, available data for the analogue substance CAS 91744-23-9 are used in a read-across approach. For details please refer to the read-across report.

Two acute toxicity studies regarding oral as well as dermal toxicity indicate that the test substance (CAS 91744-23-9) is practically non-toxic in male and female Sprague-Dawley rats.

Data regarding short-term toxicity via inhalation are not available. But as data regarding the oral and the dermal route are available, and the vapour pressure of the substance is negligible (< 5 Pa at 20 °C and 50 °C, respectively), inhalation testing is not required.

These data meet the requirements of the REACH regulation.


Justification for selection of acute toxicity – oral endpoint
No substances specific data are available for Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates. Therefore, available data for the analogue substance CAS 91744-23-9 are used. Details on the read-across justification are summarized in the attached read-across report.
An OECD 401 limit test at 2000 mg/kg bw (conducted under GLP) is available for the test substance (CAS 91744-23-9). During the study none of the animals died and animals did also not show clinical signs. Body weight gain was normal for all animals. Gross pathology did not result in any findings. Therefore, it can be concluded that the substance is practically non-toxic (LD50 > 2000 mg/kg bw).

Justification for selection of acute toxicity – dermal endpoint
No substances specific data are available for Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates. Therefore, available data for the analogue substance CAS 91744-23-9 are used. Details on the read-across justification are summarized in the attached read-across report.
An OECD 402 limit test at 2000 mg/kg bw (conducted under GLP; semi-occlusive coverage) is available for the test substance (CAS 91744-23-9). During the study none of the animals died and animals did also not show clinical signs. Body weight gain was normal for all animals. Gross pathology did not result in any findings. Therefore, it can be concluded that the substance is practically non-toxic (LD50 > 2000 mg/kg bw).

Justification for classification or non-classification

No mortalities or clinical signs were observed at appropriate dose levels.