Registration Dossier

Administrative data

Description of key information

DPGDB was found to be not irritating or corrosive to eyes or skin.

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 irritation

A study was performed to assess the skin irritation potential of DPGDB to the rabbit. The study was conducted in accordance with EPA, OECD, EC, and Japanese test guidelines, and in compliance with GLP (HLS 1998, VCL 257/973171/SE).

No dermal reactions were observed following a single semi-occlusive application of DPGDB to intact rabbit skin for four hours. DPGDB is not irritating to the skin.

A second study supports this result(International Research and Development Corporation 1975, report 163-341): 3 males & 3 females rabbits were tested (with intact skin and with abraded skin). Very slight erythema was observed in all abraded animals and two animals with skin intact at the end of the observation period. No edema was observed in any animal at any timepoint. DPGDB was not considered to be a primary skin irritant.

 

Eye irritation

An assessment of the potential of the test material DPGDB to cause eye irritation in rabbits was performed, according to EPA, OECD, EC, and Japanese test guidelines, and in compliance with GLP (HLS 1998, VCL 258/973243/SE).

0.1 mL of DPGDB was instilled into one eye of six healthy adult rabbits, and the effects observed for three days (72h). A single instillation of DPGDB into the eye of the rabbit elicited transient very slight conjunctival irritation. These reactions had resolved in all instances by one or two days after instillation. No corneal damage or iridial inflammation was observed.

DPGDB was considered as non-irritant for the eye.

 

A second study supports this result (International Research and Development Corporation 1975, 163-341):An assessment of the potential of the test material DEGDB to cause eye irritation in rabbits was undertaken, not formally to any official test guidelines but was similar to OECD 405, although in all animals the eyes were washed, either after 5 minutes or 24 hours.

For animals with 24 hours exposure, slight conjunctival redness was seen in one out of three rabbits one hour and 48 hours after exposure, in two out of three 72 hours after exposure, reverting to one out of three animals after 7 days. For animals with 5 minutes exposure, the results were broadly in line with those for the longer exposure time. No redness was observed at the end of the 7 day observation period.

No corneal damage was seen in any of the animals tested. On the basis of the results obtained, DPGDB would not be considered an eye irritant.

Justification for classification or non-classification

Studies undertaken on DPGDB show that it is not irritating to skin or eyes and as as such is not classified.