Registration Dossier

Administrative data

Description of key information

The results of the oral, dermal and inhalation studies indicate that DPGDB is not classified for acute toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 914 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
200 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity

A study was performed to assess the acute oral toxicity of the test material DPGDB when administered to rats. The study was conducted to any EU, EPA, OECD and Japanese MITI test guidelines, and in compliance with GLP .

In the definitive test, ten rats (five male and five female) were dosed at 2000 and 5000 mg/kg bodyweight. Five females were dosed at 3200 mg/kg bodyweight and five males were dosed at 6400 mg/kg bodyweight. Observations were taken for 14 days following dosing, and macroscopic pathology was performed on all animals.

The acute median lethal oral doses (LD50) to male and female rats of DPGDB were calculated to be: 5072 mg/kg bodyweight (males), 3295 mg/kg bodyweight (females), and 3914 mg/kg bodyweight (both sexes).

 

Two studies on rats and on mice support this result :

The acute oral toxicity assessment was performed in groups of five female and five male albino rats, dosed with 1281, 2034, 3229, 5126, 8137 and 12,918 mg/kg of DPGDB suspended in corn oil, then observed for 14 days post exposure. The acute oral toxicity (LD50) was found to be 5368 mg/kg bodyweight in males, 4068 mg/kg bodyweight in females, and 4673 mg/kg bodyweight to both sexes combined.

 

The acute oral toxicity assessment was performed in groups of five female and five male albino mice, dosed with 807, 1281, 2034, 3229, 5126 and 8137 mg/kg bw suspended in corn oil, then observed for 14 days post exposure. The acute oral toxicity (LD50) was found to be 4894 mg/kg bodyweight in males, 4068 mg/kg bodyweight in females, and 4462 mg/kg bodyweight to both sexes combined.

 

Acute inhalation toxicity

The acute inhaled toxicity assessment was performed in groups of five female and five male rats, exposed to a whole-body aerosol atmosphere containing approximately 200 mg/L. of DPGDB for four hours, then observed for 14 days post exposure.  Clinical signs seen during the 4 hour exposure period included decreased motor activity, eye squint, erythema, clear nasal discharge, salivation, lacrimation, tachypnea and slight dyspnea.  In addition, at the termination of the exposure period both ocular and nasal porphyrin discharge, flaccidity and ataxia were observed.

At 24 hours and for the remainder of the 14 day observation period, several rats exhibited flaccidity. Other signs recorded during the study period were; hypersensitivity to touch in two rats at 24 through 72 hours and in one rat at 4 days.

Ataxia was present in one or two rats at 24 through 72 hours and 6, 12, 13 and 14 days. Drying of the corneal surface in one rat at 6, and 7 days; corneal opacity in one to three rats from 7 through 14 days, and chemosis in one or two rats from 9 through 12 days.

Lacrimation in a few rats at 7, 8 and 9 days and clear nasal discharge in a few rats at 9, 10, 11 and 14 days.

None of the rats exposed to the test material died during the course of the observation period. On this basis, DPGDB would not be considered a toxic material by the inhalation route of administration.

 

 

Acute dermal toxicity

An acute dermal toxicity study in rats was performed to determine the toxicity by dermal exposure of the test material, DPGDB. The study was conducted according to international test guidelines, and in compliance with GLP .

Ten rats (five males and five females) were exposed to a 2000 mg/kg dose of DPGDB by the dermal route for 24 hours, then observed for 14 days following test material removal.

No rats died during the observation period, and no clinical or pathological signs were observed. On the basis of these results, it was concluded that the acute lethal dermal dose to rats of DPGDB was demonstrated to be greater than 2000 mg/kg bodyweight.

 

A second study supports this result : The acute dermal toxicity assessment was performed on two male and two female New Zealand White rabbits, exposed dermally to 2000mg/kg of DPGDB for a period of 24 hours, then observed for 14 days post exposure.

None of the rabbits exposed to the test material died during the course of the observation period. On this basis, DPGDB would not be considered a toxic material by the dermal route of administration.

Justification for classification or non-classification

The results of the oral, dermal and inhalation studies indicate that DPGDB is not classified for acute toxicity.