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Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
discriminating dose
Value:
20 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
626 mg/m³

Acute toxicity: via dermal route

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

Additional information

Acute toxicity: oral

The acute oral toxicity of octadecyl isocyanate was low with an LD50 value > 20000 mg/kg bw for male and female rats (method similar to OECD TG 401). Single administration of 20000 mg/kg bw was tolerated without mortality. In all animals lethargy was observed 20 minutes post-treatment and ended within 48 hours (Lamb and Matzkanin, 1975).

Acute toxicity: dermal

The acute dermal toxicity of octadecyl isocyanate was low with an LD50 value > 2000 mg/kg bw for male and female rats (method similar to OECD TG 402). Single occlusive administration of 2000 mg/kg bw for 24 hours was tolerated without mortalities. No clinical signs were observed (Lamb and Matzkanin, 1975).

Acute toxicity: inhalation

A study on the acute inhalation toxicity of Stearylisocyanate 65 according to OECD TG 403 was conducted on male and female rats, which were nose-only exposed to liquid aerosol in concentrations of 385, 503, 631, 768, 978 mg/m3 (gravimetric concentrations). The liquid aerosol was generated so that it was respirable to rats. Exposure to concentrations up to 503 mg/m3 were tolerated without mortality whereas concentrations equal to or exceeding 631 mg/m3 resulted in mortality occurring within the first three post-exposure days. In surviving rats the following clinical signs were observed: piloerection, bradypnea, tachypnea, labored and irregular breathing patterns, nostrils with red encrustations, cyanosis, motility reduced, limp, high-legged gait, ungroomed hair-coat, tremor, altered reflexes, hypothermia, and transiently decreased body weights. Clinical signs appeared to be largely related to respiratory effects and subsided almost entirely within the first post-exposure week. Necropsy findings were unremarkable in surviving rats whilst in rats that succumbed evidence of lung edema existed. With regard to the respirability of the aerosol generated internationally recognized recommendations such as of SOT (1992) were fulfilled i.e. the MMAD was approximately 1.5 µm (GSD ~2). In summary, the aerosolized test substance (liquid aerosol) proved to have a moderate acute inhalation toxicity to rats (LC50: 626 mg/m3). Mortality appeared to be causally related to acute lung damage and ensuing lung edema (Pauluhn, 2001).

Justification for classification or non-classification

Acute toxicity: oral

Not classified under Annex I of Directive 67/548/EEC or Annex VI-1 of Regulation (EC) No 1272/2008. According to Annex I of Regulation (EC) No 1272/2008 no classification is required.

Acute toxicity: dermal

Not classified under Annex I of Directive 67/548/EEC or Annex VI-1 of Regulation (EC) No 1272/2008. According to Annex I of Regulation (EC) No 1272/2008 no classification is required.

Acute toxicity: inhalation

Not classified under Annex I of Directive 67/548/EEC or Annex VI-1 of Regulation (EC) No 1272/2008. Deviating from that a self classification according to Annex I of Regulation (EC) No 1272/2008 with Category 3 (H331: Toxic if inhaled) is recommended based on the results of the available key acute inhalation study.