Registration Dossier
Registration Dossier
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EC number: 208-863-7 | CAS number: 544-17-2
Endpoint summary
Administrative data
Description of key information
Calciumdiformate was not irritating to intact rabbit skin.
Calciumdiformate caused reversible irritation of the rabbit's eye.
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:
- adverse effect observed (irritating)
Additional information
Skin irritation
The potential of CaFo for skin irritation was examined in a GLP OECD guideline No. 404 study using three male Himalayan rabbits. A dose of 500 mg/animal as a paste with water was applied to the shaved and intact dorsal skin. The test area was then covered with a gauze patch which was held in contact by means of semi-occlusive dressing. The skin sites were evaluated according to the table contained in the test guideline (adopted in 1992) immediately before the application of the test substance and after the 4-hour exposure. The scores were taken 60 min, 24, 48 and 72 hours after patch removal.
There was no skin reaction in any animal at any reading, i.e. the mean erythema and edema scores were 0 at all readings, and there were no pathological changes noted. Therefore, CaFo was not irritating to the skin (LPT, 1999). The study is considered to be fully valid for assessment.
Eye iritation:
The eye irritating properties of calcium diformate (100 mg) was examined in rabbits (Himalayan, 3 males) according to OECD guideline No. 405 and under GLP conditions. Marked corneal opacity (mean score 2.0), severe iritis (mean score 2.0), and marked conjunctival reactions (mean scores redness and chemosis 2.0) were seen during days 1 to 3. All reactions were reversible within the 14 day observation period. Corneal opacity and iritis were absent on day 7, conjunctival effects on day 14. Induration of the lower lid was seen in all animals on days 3 through 13 after treatment.
Overall, calcium diformate was irritating to the rabbit's eyes. Results require labeling (R41: risk of serious eye damage) and classification (risk of serious damage to eyes) (LPT, 1999). The study is considered to be valid and acceptable for assessment.
Effects on eye irritation: irritating
Justification for classification or non-classification
Skin irritation: No classification, because criteria of the regulations 67/548/EC and 1272/2008/EC are not met.
Eye irritation: Classification and labeling required.
67/548/EC: R41: risk of serious eye damage
1272/2008/EC, Classification, table 3.3.2: eye irritation category 2;
1272/2008/EC, Labeling, table 3.3.5: H319
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