Reaction mass of 1,3-diacetoxypropan-2-yl 12-acetoxyoctadecanoate and 2,3-diacetoxypropyl 12-acetoxyoctadecanoate

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure

DNEL related information

Local effects

Acute/short term exposure

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure

DNEL related information

Additional information - workers

Inhalation.

TS-ED 532 is evaluated to have no hazardous properties and shall not be classified. Absorption via the respiratory system is evaluated to be negligible. TS-ED 532 is a non-volatile liquid; the vapour pressure is approximately 5-10x10-8 Pa at room temperature (20-25 °C) and no aerosols are expected.

Dermal absorption.

TS-ED 532 is evaluated to have no hazardous properties and shall not be classified. The acute oral and dermal toxicities of TS-ED 532 are greater than 2000 mg/kg bodyweight. TS-ED 532 was not irritating in a dermal irritation test and was not a skin sensitizer in a Local Lymph Node Assay. TS-ED 532 is a liquid with a relatively high molecular weight (about 500); the water solubility is very low (0.06-0.09 mg/l at 20 °C); and the n-octanol-water partition coefficient is high (Log Pow 6.42). Dermal absorption is evaluated to be negligible. Possible local and systemic effects after dermal exposure is evaluyated to be negligible.

 

Overall, no local or systemic effects of short-term or long-term exposure to TS-ED 532 is expected in workers exposed by inhalation or dermal application. TS-ED 532 is evaluated to have no hazardous properties and shall not be classified

according to GHS and DSD-DPD. Consequently, no DNEL's have been developed.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure

DNEL related information

Local effects

Acute/short term exposure

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure

DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure

DNEL related information

Additional information - General Population

Inhalation.

TS-ED 532 is evaluated to have no hazardous properties and shall not be classified. TS-ED 532 is a non-volatile liquid; the vapour pressure is approximately 5-10x10-8 Pa at room temperature (20-25 °C), and no aerosols are expected. Absorption via the respiratory system is evaluated to be negligible and local effects in respiratory system are evaluated to be unlikely. Consequently, no DNEL has been developed for local effects after long-term inhalation exposure.

Dermal absorption.

TS-ED 532 is evaluated to have no hazardous properties and shall not be classified. TS-ED 532 is a non-volatile liquid; the vapour pressure is approximately 5-10x10-8 Pa at room temperature (20-25 °C), and no aerosols are expected. Absorption via the respiratory system is evaluated to be negligible and local effects in respiratory system are evaluated to be unlikely. Consequently, no DNEL has been developed for local effects after long-term inhalation exposure.

 

Oral exposure.

TS-ED 532 is evaluated to have no hazardous properties and shall not be classified.

The acute oral toxicity of TS-ED 532 is greater than 2000 mg/kg bw and therefore considered to be very low. N

o systemic effects were identified from long-term exposures with TS-ED 532. Oral administration of TS-ED 532, up to 5000 mg/kg bw/day for 90-days did not results in any signs of toxicity; neither did oral administration of TS-ED 532 for a period of up to 12 months. NOAEL in these studies were ≥ 5000 mg/kg bw/day and ≥ 1333 mg/kg bw/day (up to 30000 ppm), respectively.

In a multigeneration reproduction/developmental neurotoxicity study the lowest identified NOAEL was ≥ 1159 mg/kg bw/day (exposure to up to 25000 ppm in the feed) for reproductive and developmental neurotoxicity. In prenatal developmental toxicity studies a NOAEL > 1000 mg/kg bw/day for was established. In general, the metabolism of ingested TS-ED 532 is expected to be rapid with extensive hydrolytic cleavage of the 12-acetyl group and subsequent catabolism of the majority of the released acetate to CO2. Hence, no systemic effect is expected.

Genotoxicity

TS-ED 532 was shown not to have the potential to induce neither mutations nor genotoxicity in vivo and in vitro. No

evidence of pre-neoplastic changes was observed in the 90-day oral toxicity study, indicating no basis for induction of carcinogenicity in vivo.

 

Conclusion

Overall, TS-ED 532 was found to have very low acute toxicity, to be not irritating and non-sensitizing. In long-term toxicity studies, oral exposure to TS-D 532 was found not to have reproductive, including endocrine disruption, or developmental effects at the highest tested levels in accordance with the guidelines. TS-ED 532 was shown not to have potential for inducing neither mutations nor genotoxicity in vivo and in vitro at the highest tested levels in accordance with the guidelines and was evaluated not have potential to induce carcinogenicity in vivo. Systemic effects of TS-ED 532 via dermal absorption or inhalation were evaluated to be unlikely.

TS-ED 532 is evaluated to have no hazardous properties and shall not be classified

according to GHS and DSD-DPD. Thus, no DNEL has been derived.