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EC number: 231-900-3
CAS number: 7778-18-9
Calcium sulfate is not considered to be irritating to the skin or eyes.
Table 1: Primary dermal irritation following application of 0.5 g of the
30 – 60 min
Interpretation of results:
The substance was classified according to the following scale, in
accordance with Guideline 83/467/CEE, Annex VI, part IIB.
A substance or preparation is considered irritant if the inflammation of
the skin with duration of at least 24 h corresponds to one of the
- average value for the whole group of animals:
Erythemose lesions - 2 or higher
Edematose lesions - 2 or higher
- or lesions equivalent to the average values mentioned above,
calculated for each animal, to 2 animals at least.
It is necessary to use the measure performed in every reading (24, 48,
72 h) of each type of lesion to calculate the respective average values.
A substance is considered corrosive if it produces tissue destruction in
the whole skin thickness, to at least 1 animal. It is considered to
produce burns if tissue lesions in the whole skin thickness appear in an
exposure period no longer than 4 h. If tissue lesions in the whole skin
thickness appear in an exposure period no longer than 3 min, the product
is considered to produce serious burns.
Table 1: Observations of ocular alterations after administration:
Region of the eye
In a reliable OECD guideline in vivo skin irritation study (Canut
1990) 0.5 g calcium sulfate anhydrite was applied to the shaved skin of
3 New Zealand White rabbits under a semiocclusive patch for 4
hours.Animals were observed after removal of the patch at 30 and 60 mins
and 24, 48 and 72 h. The average of the erythema and edema assessments
for the 3 animals after 72 h was 0.0. Calcium sulfate was found to be
non-irritating to the skin in rabbits.
In a reliable OECD guideline in vivo eye irritation study (Canut
1990) 100 mg calcium sulfate anhydrite was instilled into the eyes of 3
New Zealand White rabbits. Ocular observations were made at 1, 24, 48
and 72 h after instillation. Grade 1 and 2 conjunctival hyperaemia as
well as grade 1 chemosis were observed 24h after application, which
fully recovered within 72h in two of three animals. Taken together,
calcium sulfate need not to be classified as irritating to the eyes.
In the in vivo skin and eye irritation studies calcium sulfate was
non-irritant and required no classification under CLP.
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