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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

A GLP study according to OECD guideline 405 and non-GLP studies similar to OECD guidelines 404 and 405 are available for PGDA.

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

Skin: no skin irritation was noted following application of 0.01 ml PGDA to the belly of rabbits. Although the dose was a tenth of the dose typically used, no dermal irritation was noted in the dermal LD50 study where rabbits were dosed with 16 ml/kg.

 

Eye: no irritation was observed in a GLP-study conducted with PGDA according to OECD guideline 405. The mean scores over all animals and for all endpoints after 24, 48 and 72 hours were 0. In a non-GLP study from 1965, slight irritation was observed in 3 out of 5 animals treated with 0.5 ml PGDA. However, the dose applied in this study far exceeds the typical dose recommended in the OECD guideline. Therefore, this study is not considered relevant for the decision on classification and labeling.

Justification for classification or non-classification

No irritation to rabbit skin or eyes was observed after treatment with PGDA. Hence, no classification is required according to EU criteria.