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Registration Dossier
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EC number: 820-225-5 | CAS number: 101747-77-7
Endpoint summary
Administrative data
Description of key information
skin irritation
Source substance Zinc bis(O,O-diisobutyl dithiophosphate) (CAS 68457 -79 -4): non GLP, similar to OECD Guideline 404, Klimisch 1, rabbit, semiocclusive, skin irritating
Source substance Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259 -15 -8): GLP, similar to OECD Guideline 404, Klimisch 1, rabbit, semiocclusive, not skin irritating
source substance Phosphorodithioic acid, mixed O,O-bis(1,3 -dimethylbutyl and iso-Pr) esters, zinc salts (CAS 84605 -29 -8): GLP, similar to OECD Guideline 404, Klimisch 1, rabbit, semiocclusive, skin irritating
eye irritation
Source substance Zinc bis(O,O-diisobutyl dithiophosphate) (CAS 68457 -79 -4): GLP, similar to OECD Guideline 405, Klimisch 1, rabbit, eye irritating
Source substance Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259 -15 -8): GLP, according to OECD Guideline 405, Klimisch 1, rabbit, eye irritating
source substance Phosphorodithioic acid, mixed O,O-bis(1,3 -dimethylbutyl and iso-Pr) esters, zinc salts (CAS 84605 -29 -8): GLP, Klimisch 1, rabbit, eye irritating
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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
skin irritation
source substance Zinc bis(O,O-diisobutyl dithiophosphate) (CAS 68457 -79 -4):
The primary dermal irritation potential of the test material was evaluated in this study with New Zealand White rabbits similar to OECD Guideline 404. The test material was administered to two separate sites (right dorsal thoracic and left dorsal thoracic). At each single site, 0.5 ml doses of undiluted test material were applied under gauze patch which was secured with tape. The patch was loosely held in contact with the skin by means of a semi-occlusive dressing for a four hour exposure period. At completion of exposure the dressing and gauze were removed and the right dorsal thoracic site was removed with paper towels moistened with distilled water; residual test material on the left dorsal thoracic dose site was removed with paper towels saturate in white oil. Application sites were evaluated in accordance with the method of Draize at approximately 60 minutes, 24, 48, and 72 hours and Day 7 after patch removal.
The Primary Irritation Index was calculated to be 4.42 for sites wiped with distilled water.
The Primary Irritation Index was calculated to be 4.0 for sites wiped with white oil (Plutnick 1986).
source substance Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259 -15 -8):
Skin irritation was assessed similar to OECD Guideline 404. Phosphorodithioic acid, O,O-bis(2-ethylhexyl) ester, zinc salt caused no skin irritation (Cooper 1986).
source substance Phosphorodithioic acid, mixed O,O-bis(1,3 -dimethylbutyl and iso-Pr) esters, zinc salts (CAS 84605 -29 -8)
The primary dermal irritation potential of the test material was evaluated in a study with New Zealand White rabbits similar to OECD Guideline 405 according to GLP. There were two groups of six rabbits. In Group 1, single 0.5 milliliter doses of undiluted test material were applied to a single site on each animal's back. In Group 2, single 0.5 milliliter doses of the test material at concentrations of 6.25, 12.5, 25 and 50% (weight to volume in mineral oil) were applied to four distinct application sites on each animal's back; each animal received a single dose of each concentration. All doses were applied under semi-occlusive dressing for a four hour exposure period. At completion of exposure the bandages were removed and the sites washed with light, white mineral oil and disposable paper towels. Application sites were evaluated in accordance with the method of Draize at approximately 24 and 72 hours after patch removal.
There were no deaths or significant body weight changes during the study period.
In Group 1, the Primary Irritation Index was calculated to be 4.3 for sites treated with undiluted test material.
In Group 2, Primary Irritation Indices of 1.5, 2.8, 3.5 and 4.0 were calculated for 6.25, 12.5, 25 and 50% w/v concentrations of the test material in mineral oil, respectively.
eye irritation
source substance Zinc bis(O,O-diisobutyl dithiophosphate) (CAS 68457 -79 -4):
In a primary eye irritation study similar to OECD Guideline 405, 0.1 ml of undiluted test substance was placed into conjuctival sac of one eye of each of the New Zealand White rabbits (3 animals).The test material elicited moderate to severe ocular irritation that included corneal opacity, iritis, and conjunctival effects. Corneal opacity persisted in all three rabbits to Day 21 (Turck 1994).
source substance Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259 -15 -8):
Eye irritation was tested according to OECD Guideline 405. In this study Phosphorodithioic acid, O,O-bis(2-ethylhexyl) ester, zinc salt caused persistent eye irritation through 21 days. Rinsing the test material out of the eyes 30 seconds after the exposure resulted in eye irrtation that was reversible within 21 days (Morris 1996).
source substance Phosphorodithioic acid, mixed O,O-bis(1,3 -dimethylbutyl and iso-Pr) esters, zinc salts (CAS 84605 -29 -8)
In a GLP-compliant primary eye irritation study, 0.1 ml of the test substance at either 25, 12.5, 10, 7.5, or 6.25% in mineral oilwas placed into one eye of each of the New Zealand White rabbits (6 animals per concentration). The test substance produced ocular irritation up to 21 days at a concentration of 25% and moderate irritation at a concentration of 12.5%.
Justification for classification or non-classification
Based on the presented studies the source substances are classified as follows
source substance Zinc bis(O,O-diisobutyl dithiophosphate) (CAS 68457 -79 -4): skin irritating Cat. 2 (Plutnick 1986)
source substance Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259 -15 -8): not skin irritating (Cooper 1986)
source substance Phosphorodithioic acid, mixed O,O-bis(1,3 -dimethylbutyl and iso-Pr) esters, zinc salts (CAS 84605 -29 -8): skin irritating Cat. 2
source substance Zinc bis(O,O-diisobutyl dithiophosphate) (CAS 68457 -79 -4): eye irritation Cat. 1 (Turck 1994)
source substance Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259 -15 -8): eye irritation Cat. 1 (Morris 1996)
source substance Phosphorodithioic acid, mixed O,O-bis(1,3 -dimethylbutyl and iso-Pr) esters, zinc salts (CAS 84605 -29 -8): eye irritating Cat. 1
Based on the results for the three source substances, the registered substance is classified as skin irritant, Cat. 2 (H315) and eye irritant Cat. 1 (H318).
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