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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol was tested for its skin irritant properties in 6 New Zealand White rabbits. The study was performed according to OECD Guideline 404. Effects on the skin (erythema grades up to 2 and edema scores up to 2) were observed some animals 24 hours after application. These signs were fully reversible within the 7 days observation period. 
Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol was tested for its eye irritant properties in 6 New Zealand White rabbits.The study was performed according to OECD Guideline 405. 
Effects on conjunctivae, iris and cornea (chemosis score: 4; redness score: 2; opacity score: 4) were observed in all animals one hour after application and persisted to the study termination after 22 days. One animal was found dead on day 12 post application.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation: 1 key study available: not irritating

Eye irritation: 1 key study available: corrosive

There is one fully reliable study available on the skin irritancy potential.Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycolwas tested for its skin irritant properties in 6 New Zealand White rabbits. The study was performed according to OECD Guideline 404. Effects on the skin (erythema grades up to 2 and edema scores up to 2) were observed some animals 24 hours after application. These signs were fully reversible within the 7 days observation period.

There is one fully reliable study available on the eye irritancy potential. Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol was tested for its eye irritant properties in 6 New Zealand White rabbits.The study was performed according to OECD Guideline 405.

Effects on conjunctivae, iris and cornea (chemosis score: 4; redness score: 2; opacity score: 4) were observed in all animals one hour after application and persisted to the study termination after 22 days. One animal was found dead on day 12 post application.

Justification for selection of skin irritation / corrosion endpoint:
Guideline conform GLP study.

Justification for selection of eye irritation endpoint:
Guideline conform GLP study with sufficient reporting.

Effects on eye irritation: corrosive

Justification for classification or non-classification

With reference the reported scores and the reversibility of the observed effects Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol has not to be classified as irritant to the skin according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

With reference the reported scores and the irreversibility of the observed effects Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol has to be classified as irritant to the eyes (R41 - Risk of serious damage to the eyes; H318 - Causes serious eye damage) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).