1-Butanamine, N-[3-(trimethoxysilyl)propyl]-, reaction products with (trimethoxysilyl)-N-[(trimethoxysilyl)propyl]-1-propanamine and 1,6-diisocyanatohexane homopolymer

Endpoint summary

Description of key information

LD50 (oral; OECD423) > 2000 mg/kg (Bioassay, 2012)
LC50 (inhalation, liquid aerosol, OECD 403) = 5.031 mg/L (BASF, 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 adverse effect observed

Additional information

Acute oral toxicity:

The acute oral toxicity of the test item was evaluated in rats according to OECD 423 guidelines and GLP (Bioassay, 2012). The test item was administered by oral route (gavage) twice to two groups of three fasted female Wistar rats at the dose-level of 2000 mg/kg (limit test) under a dose-volume of 10 mL/kg. Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test item. All animals were subjected to necropsy.

Neither mortality nor clinical signs occurred during the examination period. The mean body weight of the first test group increased throughout the study period within the normal range. The mean body weight of the second test group increased throughout the study period within the normal range. Only one animal lost weight in the second observation week.

Conglomerate in the stomach in two animals of the first and in all animals of the second administration group was noted at necropsy on the last day of observation (six females). Additionally dark spotted small intestine and white granular inclusion in the hypogastric region were observed in the one animal of the second administration group, which lost weight in the second post-exposure week.

Under the conditions of this study the median lethal dose of iGloss Crosslinker (ZQ54-2211) after oral administration was found to be greater than 2000 mg/kg bw in rats.

Acute inhalation toxicity:

To determine the acute inhalation toxicity (single 4 -hour exposure, head-nose only) of iGloss Crosslinker (ZQ54-2211) as a liquid aerosol, a GLP compliant study (BASF SE, 2012) was performed in male and female Wistar rats according to OECD-Guideline method 403. For technical reasons the test substance was sprayed as solution with anhydrous acetone. The following measured concentrations were tested: 1.257, 2.869 and 5.134 mg/L (analytical concentration). No lethality was observed in male and female animals at 1.257 mg/L and 2.869 mg/L. At 5.134 mg/L three of five female animals but no males died or were killed in a moribund state died. Lethality was observed either during exposure, after exposure on study day 1 or on study day 6.

Clinical signs of toxicity in animals exposed to 1.257 mg/L comprised accelerated and abdominal respiration, respiration sounds, colorless discharge and red encrusted nose, piloerection and substance contaminated. These various findings were observed from hour 4 of exposure through to study day 5. No clinical signs and findings were observed from study day 6 onwards. The mean body weights of the animals decreased during the first post exposure observation day and increased from study day 3 onward. No gross pathological abnormalities were noted during the necropsy at the termination of the post exposure observation period.

Clinical signs of toxicity in animals exposed to 2.869 mg/L were similar to those described at lower concentrations. Some more unspecific symptom (e.g. alopecia) was seen. These various findings were observed from hour 3 of exposure. No clinical signs and findings were observed in the male animals from study day 7 onwards. The clinical signs and finding were observed in the female animals during the whole study period. The mean body weights of the animals decreased during the first post exposure observation day and increased from study day 3 onward. No gross pathological abnormalities were noted during the necropsy at the termination of the post exposure observation period.

Clinical signs of toxicity in animals exposed to 5.134 mg/L comprised accelerated and labored respiration, abdominal respiration, gasping, respiration sounds, closed eyelid, red encrusted eye, colorless or red discharge and red encrusted nose, swelling nose, alopecia, dehydrated and poor general condition, salivation, pale of the skin, piloerection and substance contaminated. The mean body weights of the male animals decreased during the first post exposure observation day and increased from study day 3 onward. The mean body weights of the female animals decreased during the first few post exposure observations days and increased from study day 7 onward. During necropsy of the one female animal that was found dead on study day 1, dark-red discoloration in all lung lobes, edema and red encrusted nose were noted during necropsy. Necropsy findings of the one female animal that were killed in a moribund state on study day 1 comprised dark-red discoloration in all lung lobes, edema of the lung and. Necropsy findings of the one female animal that were killed in a moribund state on study day 6 comprised at the edge of the right cranial lung lobe a focus, red encrusted nose, alopecia on the left nose region and substance contaminated fur. The remaining animals showed no gross pathological abnormalities during the necropsy at the termination of the post exposure observation period.

To further evaluate the macroscopic findings, histopathological examination was carried out of the respiration tract (nasal cavity, larynx, trachea, lung) from female animal no. 609 which was killed in a moribund state on study day 6. The lung showed a minimal to slight diffuse acute congestion and a minimal to slight diffuse alveolar histiocytosis. The nasal cavity showed a slight to moderate multifocal necrotizing and purulent rhinitis with degeneration and regeneration. The larynx and trachea were without findings.

Under the conditions of this study the LC50 for male and female rats after liquid aerosol inhalation exposure of iGloss Crosslinker (ZQ54-2211) was estimated to be 5.031 mg/L (analytical concentration).

Justification for selection of acute toxicity – oral endpoint
GLP guideline study

Justification for classification or non-classification

Based on the available acute oral and inhalation toxicity study, no classification and labeling is required (according to Directive 67/548/EEC and according to CLP).