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Diss Factsheets

Administrative data

Description of key information

Both for the skin and eye irritation, in vivo key studies according to OECD 404 and 405  were available for the corresponding sodium salt of the substance, docusate sodium. These data are used for read-across to the substance registered. These data demonstrate that the test substance is highly irritating to skin and resulting in irreversible eye damage. The overall  irritation scores  were 7.8 of max. 8 (1- 72 h) in the key study for skin irritation and 47 of max. 110 (1-72 h) in the key study for eye irritation.  This information in combination with supporting studies resulted in skin irritation EU GHS category 2 and eye damage EU GHS category 1.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Data are available for the corresponding sodium salt of the substance, docusate sodium. These data are used for read-across to the substance registered.

A key study forskin irritationwas performed in rats according to OECD 404 test guideline, which was considered to be reliable, adequate and relevant (Elementis, Mürmann 1988). A volume of 0.5 mL Docusate sodium (70% solution in ethanol/methanol and water) was applied on 6 cm2 shaved skin of 3 male rabbits by occlusive application. After this period, the skin area was washed with warm water and observed after 1, 24, 48, 72 hours and 6, 8, 10 and 14 days. The results showed that there was an irritation index of 7.8/8 over the 1 -72 hour period and some effects were still visible at 14 days.

A support study was conducted by application of 0.5 mL Docusate sodium to intact and abraded skin of 6 male rabbits according to FHSA (Federal Hazard Act Substance) and CFR 1500.41 method for 24 hours under occlusive dressing (Cytec, McGinty 1977a). The reactions were evaluated after 24 and 72 hours and the substance was strongly irritating as indicated by a mean primary irritation score of 3.83/4.

A key study foreye irritationwas conducted with Docusate sodium according to OECD 405 test guideline, which was considered to be reliable, adequate and relevant (Elementis, Mürmann 1988). A volume of 0.1 mL Docusate sodium (mixture of 70% docusate sodium, ethanol in methanol, water) was applied to the eyes of 3 male rabbits. After 72 hours, fluorescein solution was applied for cornea evaluation and rinsing was performed with warm physiological solution. Evaluation after 1, 24, 48 and 72 hours and 6, 8, 10, 13, 17 and 21 days after application showed irreversible damage (including turbidity of the cornea). The mean overall irritation score for 1 -72 hours was 46,67/110.

A support study was conducted by application of a volume of 0.1 mL (0.1g) Docusate sodium to the eyes of 6 rabbits according to FHSA (Federal Hazard Substance Act) and CFR 1500.41 method. Evaluation after 24, 48 and 72 hours showed that the substance was irritating as indicated by changes of the cornea, iris and conjunctiva up to 72 hour (Cytec, McGinty 1977a).

In summary, both skin and eye irritation studies were available showing that Docusate sodium is irritating to skin and resulting in irreversible eye damage, resulting in the need for classification and labeling.

Effects on skin irritation/corrosion: highly irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the strong skin irritation (EU GHS category 2) and irreversible eye damage (EU GHS category 1), classification is warranted.