reaction product of diphenylmethanediisocyanate, octylamine, 4-ethoxyaniline and ethylenediamine (1:0,37:1,53:0,05)

Endpoint summary

Description of key information

Urea 4 was tested for acute toxicity via the oral and the dermal routes in two limit tests in rats according to OECD Guideline 423 and OECD Guideline 402 respectively. No mortality was noted following administration of single oral and dermal doses of 2000 mg/kg bw (limit dose). The LD50 values determined for the oral and the dermal route were > 2000 mg/kg bw. A slight irritant effect on the application area in 3 out of 5 female animals were recorded during the acute dermal study. No other clinical signs were observed and no other macroscopic findings were recorded in autopsy following oral and dermal exposures. The test for acute inhalation toxicity was waived according to REACH Regulation No. 1907/2006, Annex VIII, 8.5.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline conform study

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

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP and guideline conform study

Additional information

Acute oral toxicity

The test substance Urea 4 was tested for its acute oral toxicity in a limit test according to EU Method B.1, OECD Guideline 423 and EPA OPPTS 870.1100. The test substance was administered in a dose of 2000 mg/kg bw (limit dose) to groups of 3 male and 3 female Wistar rats in a single exposure via gavage. No mortality and no clinical signs of toxicity were observed within the 14 days observation period. Additionally, no gross pathological changes were recorded at necropsy. The LD50 value was determined greater 2000 mg/kg bw based on the available data.

Acute dermal toxicity

The test substance Urea 4 was tested for its acute dermal toxicity according to EU Method B.3, OECD Guideline 402 and EPA OPPTS 870.1200. The test item was applied to clipped backs (appr. 10 % of the body surface) of 5 male and 5 female Wistar rats in limit dose of 2000 mg/kg bw (limit dose). The application site was covered with a semi-occlusive dressing for a 24 hours contact time. Observations were recorded daily for a period of 14 days. No mortality was observed. The LD50 value was determined greater 2000 mg/kg bw. No clinical signs of toxicity were observed throughout the observation period with the exception of a slight irritant effect on the application area in 3 out of 5 female animals. Furthermore, no weight loss or other clinical signs were observed. No compound related macroscopic findings were recorded in necropsy.

Acute inhalation toxicity

The test for acute inhalation toxicity was waived. According to REACH Regulation No. 1907/2006/EEC, Annex VIII, 8.5 data for maximum two routes of exposure are to be provided. As data on acute oral and acute dermal toxicity were available, acute toxicity via the inhalation route was not determined.

Justification for selection of acute toxicity – oral endpoint
One reliabe study available

Justification for selection of acute toxicity – dermal endpoint
One reliabe study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008 (oral)

Based on the results of the acute oral toxicity LD 50 > 2000 mg/kg bw the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the eighteenth time in Regulation (EU) 2022/692.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008 (dermal)

Based on the results of the acute dermal toxicity LD50 > 2000 mg/kg bw the substance is not considered to be classified for acute dermal toxicity under Regulation (EC) No 1272/2008, as amended for the eighteenth time in Regulation (EU) 2022/692.