2-ethylhexyl 14-ethyl-6,6-dioctyl-4,8,11-trioxo-5,7,12-trioxa-6-stannaoctadeca-2,9-dienoate

Endpoint summary

Description of key information

LD50 (oral) = 3793 mg/kg (male/female rat)

LD50 (dermal) >2000 mg/kg bw (male/female rat)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 793 mg/kg bw

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

Additional information

Acute Oral Toxicity

The acute toxicity of the substance was assessed after the single oral administration of the substance at 4 g/kg bw in white mice. The dose was selected based on a preliminary study (48 -hr observation period) where an LD50 = 2700 mg/kg bw was determined. After 24 hours all animals were sacrificed and histopathology was performed in some tissues. No mortality was observed during the study. Some clinical signs, macroscopical and microscopical findings were observed in the liver, spleen, lungs, stomach and colon. However, since all animals were sacrificed 24 hours after intubation, reversibility of these signs was not able to be evaluated.

The (non) acute toxicity of the substance is supported by available experimental data on Similar Substance 02. Its acute oral toxicity was evaluated in the key study according to the standardised guideline OECD 401. Albino rats were administered a single oral dose of the test material by gavage at dose levels of 1000, 2500 and 5000 mg/kg bw. Five animals per sex were dosed at each concentration and the animals observed for 14 days. Four male and four female animals died within 5 days at the 5000 mg/kg bodyweight dose level. No further mortality was seen. Clinical signs included sedation, dyspnoea, exophthalmus, ruffled fur and exhibiting a curved body position. All survivors had recovered by the end of the observation period and no gross abnormalities were observed at necropsy. LD50 = 3793 mg/kg bw.

For chemical safety assesseent the LD50 = 3793 mg/kg bw is used since it is obtained by a study performed according to the OECD guideline 401 and under GLP conditions. In addition, an adequate observation period which permits the better evaluation of the presence/absence of clinical signs and mortality. The LD50 of 2700 mg/kg bw is not used for CSA even if it is obtained by a study conducted on the substance, since the observation period was lower (only 48 hours) and no details on clinical signs and mortality are known.

Acute Inhalation Toxicity

In accordance with Column 2, point  8.5.2 of Annex VIII, testing by the inhalation route is appropriate if exposure of humans via inhalation is likely, taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Based upon the available vapour pressure of 1.58.10^-013 Pa at 25 °C, exposure to the test material via inhalation is considered unlikely. Acute toxicity data via the oral route and via the dermal route (on Similar Substance 02) are instead provided.

Acute Dermal Toxicity

In the acute dermal toxicity study on Similar Substance 02, a LD50 > 2000 mg/kg bw was determined. Justification for Read Across is given in Section 13 of IUCLID. The acute dermal toxicity of the analogue substance was investigated in accordance with the standardised guidelines OECD 402 and EU Method B.3. During the study, a group of ten animals (five males and five females) was given a single 24 hour, semi-occluded dermal application of the test material to intact skin clipped free of hair at a dose level of 2000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. During the study there were no deaths and no signs of systemic toxicity were observed. One female showed bodyweight loss during the first week but expected gain in bodyweight during the second week and one female showed expected gain in bodyweight during the first week but bodyweight loss during the second week. Remaining animals showed expected gains in bodyweight over the study period. Signs of dermal irritation noted were very slight erythema, crust formation and desquamation. There were no signs of dermal irritation noted at the test site of one male. No abnormalities were noted at necropsy.

Justification for Read Across is given in Section 13 of IUCLID.

Justification for classification or non-classification

Fot the assessmenent of classification of the substance data on the substance but also data on analogue substances is used.

LD50 (oral) = 3793 mg/kg bw.

LD50 (dermal) > 2000 mg/kg bw.

The LD50 values determined via both dermal and oral route are higher than the threshold for classification. The substance is therefore not classified for acute toxicity according to the CLP Regulation (EC) No. 1272/2008.