Sorbitan monolaurate, ethoxylated

Endpoint summary

Description of key information

skin irritation (OECD 404): not irritating
eye irritation: based on a weight of evidence approach, all available irritation/corrosion studies for the test substance revealed no eye irritating effects.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

A skin irritation/corrosion study was performed in accordance with OECD 404 (Evonik 2012) with sorbitan monolaurate, ethoxylated (<2.5 EO, Polysorbate 21, CAS 9005-64-5). 0.5 mL of the unchanged test substance was applied on a patch to the shaved skin site of 3 male New Zealand White rabbits for 4 hours under semi-occlusive conditions. Afterwards, the gauze patch was removed and the treated skin site was cleaned with tap water. Skin reactions were observed at 1, 24, 48 and 72 h after patch removal and evaluated according to the OECD scoring system. A mean erythema score of 0.89 and a mean edema score of 0 was calculated for all animals. Erythema was fully reversible within 7 days. Thus, under the test conditions, the test substance was not irritating to the skin.

Eye irritation

To assess the eye irritating properties of the test substance, a weight of evidence approach was considered based on the data of sorbitan monolaurate, ethoxylated (<2.5 EO, Polysorbate 21, CAS 9005-64-5) and sorbitan monolaurate, ethoxylated (20 EO, Polysorbate 20, CAS 9005-64-5). Smiliar to OECD 405, unchanged sorbitan monolaurate, ethoxylated (<2.5 EO, Polysorbate 21, CAS 9005-64-5) was applied in one eye of each of 9 New Zealand White rabbits (Croda 1963). The untreated eye served as control. In three animals, washing with water was performed 2 sec after instillation and thus, results of these animals were not taken into account for assessment. 1, 24, 48, 72 and 96 h after test substance instillation, the grades of ocular reaction on conjunctivae, cornea and iris were recorded in all 6 animals with unwashed eyes. Cornea, iris and conjuctivae scores were 0 at the 24, 48 and 72 h time points. Thus, under the applied test conditions, the test substance was not considered as eye irritant. Data on chemosis were not given. Under the test conditions, the test substance was not irritating to the eyes. Treon et al. (1963) investigated the eye irritating potential of polysorbate 21 in a Draize test. 0.1 mL of the unchanged test substance was instilled into one eye of each of 6 animals. The animals were observed for up to 7 days. Mean irritation scores for cornea, iris, conjunctivae and chemosis were 0 for all animals. Details on the exact time points of reading for evalutation were not given. Furthermore, polysorbate 20 (20 EO) was tested in a Draize test. 0.1 mL of the unchanged test substance was instilled into one eye of each of 9 rabbits (Draize 1952). In three animals, washing with water was performed 2 seconds after instillation and thus, results of these animals were not taken into account for hazard assessment. The animals were observed for 7 days. No individual data on irritation scores were given, but 100% test substance was evaluated as “maximum tolerated concentration” at which no corneal or iris lesions were evident by the seven-day reading. In a further study with polysorbate 20, eye injury involving erythema, edema, necrosis, vascularisation of the sclera and/or cornea, pannus and opacity as well as severity and duration of injury was investigated (Hazleton 1952). Evaluation of the eye irritancy was adopted on the basis of a reaction scale and duration of effects following application to the eyes. In detail, concentrations of 1 to 10% were considered as severe irritants, 10 to 20% as moderate, and above 20% as mild. For the test substance an "irritation potential" of 100% was reported. To the authors definition, this value means a minimum degree of irritation or absence of irritation after treatment with the test compound. Thus, polysorbat 20 was not considered as eye irritant. In addition to the animal data human data are available. Polysorbate 20 was applied into the eyes of human vounteers at concentrations of up 40%. Substance instillation was conducted in a cumulative approach (6 times during 1 hour) and also as single drop application. Corneal permeability was investigated afterwards. The only effect observed was an increase in penetration averaging 5 times over controls with single drops containing the test substance. No ocular irritation was observed. Taking all data into consideration, it was concluded that the test substance has no corrosive and irritating properties.

 

Justification for selection of skin irritation / corrosion endpoint:
The selected study is the most adequate and reliable study based on overall quality assessment (refer to the endpoint discussion for further details).

Justification for selection of eye irritation endpoint:
Hazard assessment is based on the weight of evidence from all available studies.

Justification for classification or non-classification

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