Sorbitan monolaurate, ethoxylated

Endpoint summary

Description of key information

Acute toxicity:
Oral: based on a weight of evidence approach, all available acute oral toxicity studies on the test substance resulted in acute oral LD50 in rats greater than 2000 mg/kg bw.
Inhalation (OECD 403), rat, 4 hour exposure: LD50 > 5.1 mg/L
Dermal: no study available

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information on the test substance comprises studies which each alone are regarded insufficient for assessment (Klimisch score 4). However, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral

For sorbitan monolaurate, ethoxylated (<2.5 EO, Polysorbate 21, CAS 9005-64-5) data is available for polysorbates with different numbers of oxyethylene-groups in the molecule and is considered in a weight of evidence for the hazard assessment together with sorbitan monolaurate, ethoxylated (20 EO, Polysorbate 20, CAS 9005-64-5). For polysorbate 21 a secondary source with very limited documentation is available which defines a LD50 >33800 mg/kg bw without further information (Elder 1985). For polysorbate 20 oral acute toxicity data is available for rats and mice (Bartsch 1976). 5 male and 5 female Sprague-Dawley rats as well as 5 male and 5 female SPF-NMRI mice were treated with 30 mL/kg bw test substance, corresponding to 32850 mg/kg bw (calculation based on a density of 1.095 g/cm³, see chapter 4.4). Death occurred within 24h, but no further details were given neither on clinical signs, body weight changes or gross pathology. The LD50 was set at 32850 mg/kg bw. Furthermore, polysorbate 20 was tested in a standard acute method with 57 male rats and 47 hamsters, respectively, dosed with concentrations of 36700 and 18000 mg/kg bw, respectively (Eagle 1956). The animals were observed for 7 days. No further details were given on mortality, clinical signs, body weights and gross pathology and the LD50 was determined to be 36700 for rats and 18000 mg/kg bw for hamsters.

Inhalation

An acute inhalation toxicity study was performed with sorbitan monolaurate, ethoxylated (<2.5 EO, Polysorbate 21, CAS 9005-64-5) according to OECD 403 under GLP conditions. Five male and female Wistar rats each were once exposed via nose to 5 mg/L to an aerosol of the test substance for 4 hours (Evonik 2012). No mortality occurred and no clinical signs were observed during the exposure and in the following observation period of 14 days. Body weight gain in males and females was within the expected range and no abnormalities were found at macroscopic post mortem examination of the animals. The LC50 was therefore set to be higher than 5 mg/L.

Dermal

No reliable data on dermal toxicity of sorbitan monolaurate, ethoxylated (<2.5 EO, Polysorbate 21, CAS 9005-64-5) is available. However, one poorly documented dermal acute toxicity study was published by the CTFA performed similar to OECD 402 which revealed a LD50 >3000 mg/kg bw for polysorbat 20 in albino guinea pigs as no clinical signs or adverse findings were determined in gross and histopathology after topical exposure to 3000 mg/kg bw for 24 hours.

Justification for selection of acute toxicity – oral endpoint
Hazard assessment is based on the weight of evidence from all available studies on the test substance.

Justification for selection of acute toxicity – inhalation endpoint
There is only one study available.

Justification for selection of acute toxicity – dermal endpoint
No study required since exposure of humans via dermal uptake is unlikely taking into account the physico-chemical properties of the substance and QSAR prediction.

Justification for classification or non-classification

The available data on acute toxicity (oral and inhalation) of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 and Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

No data on acute dermal toxicity is available.