Urea, reaction products with diethylene glycol, formaldehyde and glyoxal

Endpoint summary

Description of key information

LD50(oral) > 2000 mg/kg (Bioassay, 2012)
LD50(dermal) > 2000 mg/kg (Bioassay, 2012)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity:

In an acute oral toxicity study performed according to the Acute Toxic Class method (OECD 423 Guideline and GLP), 2000 mg/kg bw of the undiluted test item Fixapret PC, vor Magnesiumchlorid- Zugabe was administered to two test groups of three fasted Wistar rats by gavage. · No mortality occurred · No signs of systemic toxicity were observed in the animals · The mean body weight of the animals increased within the normal range throughout the study period · No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.

Acute inhalation toxicity

This information is not available

Acute dermal toxicity

In an acute dermal toxicity study (Limit Test according to OECD 402 guideline and GLP), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item Fixapret PC, vor Magnesiumchlorid-Zugabe to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi- occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. · No signs of systemic toxicity were observed in the animals. · No mortality occurred. · The following test item-related local effects were recorded during the course of the study: Slight yellowish discoloration of the application area in all animals. The mean body weight of the male animals increased within the normal range throughout the study period. The mean body weights of the female animals did not significantly change during the first post-exposure observation week, probably due to the bandage procedure, but increased during the second week within the normal range. · No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw

Justification for classification or non-classification

Based on the available acute oral and dermal toxicity studies, the substance was neither classified according to Directive 67/548/EEC nor according to CLP.