Polymer with 2-Butyne-1,4-Diol and (Chloromethyl-)Oxirane, Brominated, Dehydrochlorinated, Methoxylated

Endpoint summary

Description of key information

The substance showed moderate acute oral toxicity in male rats with a LD50 of 917 mg/kg bw. In a range finding inhalation study, the LC50 was determined at >4900 mg/m3 for male and female rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

917 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Dose descriptor:

LC50

Value:

4 900 mg/m³ air

Additional information

Oral route

In a GLP compliant acute oral toxicity study, performed according to a protocol similar to the OECD guideline 401, male Wistar rats (5/dose) were exposed to 250, 500, 1000, and 2000 mg/kg bw of Polyol IXOL M125 (Dunphar B.V. 1986). At 250 mg/kg bw no mortalities were observed; at 500 mg/kg bw, 1 animal died; at 1000 mg/kg bw: 3 animals died and 2000 mg/kg bw: 4 animals died. In survivors, in the first days after dosing there was a weight loss in all dose groups, except the 250 mg/kg bw group. Thereafter there was a recovery. Clinical signs were mainly indicative of effects on the autonomic nervous system (ptosis, diminished respiratory rate, respiratory difficulties, piloerection and hypothermia), on the central nervous system (apathy and positional passivity), on motor coordination (abnormal gait, abnormal body posture, diminished locomotor activity, loss of righting-reflex) and on muscle tone (decreased abdominal and limb tone and paralysis). Autopsy of rats that died as a result of treatment, revealed effects on the gastro-intestinal tract (irritation), kidneys (pale), liver (pale), lungs (red spots) and thymus (red spots). In the surviving animals no abnormalities were detected. The LD50 was determined to be 917 mg/kg bw.

Inhalation route

In a GLP compliant range finding inhalation toxicity study, the acute inhalation toxicity of Polyol IXOL M125 was investigated (TNO Triskelion BV 2012). In this study, groups of 3 rats per sex were exposed to 0, 0.5, 1.7 or 4.9 g/m3 Polyol IXOL M125 for 6 hours per day, 5 days per week, over a 7-day period. Clinical signs consisted of increased kidney weights in females ofthe mid and high concentration, increased liver weights in females of all exposed groups, and increased relative liver weights in males of the mid and high concentration group. Histopathological examination of the upper airways revealed treatment-related changes in the larynx at all concentration levels. Microscopic changes in the nasal tissues were limited to animals of the high concentration and one animal of the mid concentration group. At necropsy, no treatment-related macroscopic abnormalities were observed. Mortality did not occur throughout the study. It is therefore concluded that the LC50 is above 4.9 g/m3 for male and female rats.

 

Dermal route

In accordance with column 2 of REACH Annex VIII and IX, as acute toxicity studies for the oral and inhalation route are available, no study regarding the dermal route is needed.

 

Justification for classification or non-classification

As no mortality was observed after 5 days of inhalation exposure (LC50 > 4900 mg/m3, the highest dose tested), classification for acute inhalation toxicity is not needed.

The substance has to be classified for Acute toxicity, Cat. 4 via the oral route (H302, harmful if swallowed) according to the EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.