Registration Dossier

Administrative data

Description of key information

Based on read-across following an analogue approach, ashes (residues), cenospheres are not considered irritating to the skin and eyes.

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)

Additional information

There are no substance specific data available on the skin and eye irritation potential of ashes (residues), cenospheres.

Ashes (residues), cenospheres and ashes (residues), coal share a common production process as substances derived from coal combustion. Ashes (residues), cenospheres represent a fraction of ashes (residues), coal separated by physical means. Both substances exhibit similarities in physicochemical properties and chemical composition. The main differences consist in a much lower content of water soluble matter and the particle size distribution of ashes (residues), cenospheres.

In terms of hazard assessment, studies available for ashes (residues), coal are therefore taken into account by read-across following an analogue approach, the results of these studies being considered a worst case for ashes (residues), cenospheres.

Skin irritation

Ashes (residues) were tested for acute dermal irritation/corrosion according to OECD guideline 404 and complying with GLP. Three albino rabbits were exposed to 0.5 g of test substance, applied onto the clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at 1, 24, 48 and 72 hours after exposure. The test substance was applied first on the skin of one rabbit, in which very slight erythema was observed upon removal of the patch after the 4-hour exposure. In a confirmatory test, two more rabbits were used. No evidence of irritation/corrosion effects was observed on the skin and no other signs of intoxication were seen. The mean erythema and edema scores over 24, 48 and 72 h were both 0 for all three animals (Rösslerová, 2008).

 

Eye irritation

Ashes (residues) were tested for eye irritation/corrosion in albino rabbits in a study performed according to the OECD guideline 405 and complying with GLP. The test material (0.1 g) was applied into the conjunctival sac of one eye and removed after 24 h by rinsing with water; the other eye served as control. The eyes were examined and scored 1, 24, 48 and 72 h after application. Initially, one animal was tested only, in which no corrosive effects were observed. The negative response was confirmed using two additional animals. Conjunctivae and chemosis effects were observed in all animals at 1 h post-application: some blood vessels were hyperaemic (injected) and in one animal some swelling above normal was noted. No signs of eye irritation were observed at the subsequent readings. The average cornea, iris, conjunctivae and chemosis scores over 24, 48, and 72 h were all 0 for all animals (Rösslerová, 2008).


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on read-across following an analogue approach, the available data on the skin and eye irritation potential of ashes (residues), cenospheres is conclusive but not sufficient for classification according to the DSD (67/548/EEC) and GHS (CLP, 1272/2008/EC) criteria for classification and labelling.