Registration Dossier

Administrative data

Description of key information

oral
rat: LD50 > 2000 mg/kg bw (GLP, OECD 425; Langobardi 2003)
dermal
rat: L50 > 2000 mg/kg bw (GLP, OECD 402; Langobardi 2004)
inhalation
no reliable data availabe

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

There are reliable data available to assess the acute toxicity of the substance after oral, dermal and inhalative application.

Oral

In a GLP compliant study performed according to OECD test guideline 425 (Longobardi, 2003), 5 female Sprague-Dawley rats received 2000 mg/kg bw of hexaoxatricosane by gavage and were subsequently observed for 14 days. At the end of the observation period, all survivors were sacrificed and submitted to gross-pathological examination. One animal died at 2000 mg/kg bw within approximately one hour of dosing, therefore the LD50 level was > 2000 mg/kg bw. The clinical signs observed at 2000 mg/kg bw comprised convulsions, lacrimation, salivation, lethargy, piloerection, reduced activity on day 1 and hunched posture on days 2 and 3. No abnormalities were observed in any animal at the necropsy examination performed at the end of the observation period or in the early decedent animal.

In a supporting study the acute oral toxicity of hexaoxatricosane in Sherman Wistar rats was determined to be approximately 3310 mg/kg (Shelanski, 1958)

 

Dermal

There are two studies available adressing the acute dermal toxicity of hexaoxatricosane in two different species. In a GLP compliant study according to OECD test guideline 402 male and female Spraque-Dawley rats (10/sex/dose) received a single dermal dose of 2000 mg/kg bw over 24 hours (Longobardi, 2004). After removal of the test substance the test animals were observed for 14 days. No mortality occured. Apart from reduced body weight gain in the female group at the end of the observation period no clinical signs of toxicity and no pathological abnormalities were observed.

The findings in the key study are supported by a second acute dermal toxicity study in rabbits (Green, 1977). Six male and six female rabbits were topically exposed to 2000 mg/kg bw of the test substance for 24 h. No mortalities and no signs of toxicity were observed.

Inhalation

Limited information is available on the acute inhalation toxictiy of hexaoxatricosane (Green, 1977). For both, vapor and aerosol an inhalation hazard test with whole body exposure for 1 hour was performed in rats and mice. A very high aerosolic concentration of 200 mg/l was reported. This value is not comprehensible and therefore, the reference is considered as not reliable (Klimisch code 3).

No human information is available on the acute toxicity (oral, dermal and inhalation) of hexaoxatricosane.

Justification for classification or non-classification

Based on the available data on the acute toxicity of hexaoxatricosane no classification is warranted according to the criteria of both, 67/548/EEC and CLP regulation (EC) 1272/2008.