Pentadecan-15-olide

Endpoint summary

Description of key information

Acute toxicity: oral: LD50 > 2000 mg/kg bw (WoE).
Acute toxicity: dermal: LD50 > 2000 mg/kg bw ( WoE).
Acute toxicity: inhalation: waiver.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Both read-across studies are GLP compliant and have a Klimisch score 2 whereas the study conducted on the substance itself is not GLP-compliant and has a Klimisch score 4.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

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

Quality of whole database:

Both read-across studies are GLP compliant and have a Klimisch score 2 whereas the study conducted on the substance itself is not GLP-compliant and has a Klimisch score 4.

Additional information

Acute toxicity: oral

In the non-GLP study, rats were administered a single oral dose of 5000 mg test material/kg bw. No mortality was observed throughout the study. This study was conducted before GLP and guidelines implementation and was only poorly described. Therefore a weight of evidence approach using the supporting substance (EC 422 -320 -3) was deemed more reliable to conclude on this endpoint. This read-across is justified is Iuclid section 13.

Two studies were available on the supporting substance. The two limit acute oral toxicity studies were performed according to the OECD test guideline No. 401 or 423 and were in compliance with GLP. Rats were administered a single oral dose of 2000 mg test material/kg bw by gavage. No mortality and no clinical signs were observed throughout the two studies. There was no adverse effect on bodyweight gain. In the OECD 401, at necropsy, the livers of all the males and two of the females were found to be swollen and/or appeared darkened. In most of the females and a proportion of males, the renal cortex appeared mottled. All other findings are considered to be consistent with the background macroscopic pathology of this strain of rat. These findings were not observed in the OECD 423 study.

The oral LD50 worst case value, 2000 mg/kg bw, was selected to conclude on this endpoint.

Acute toxicity: dermal

In the non-GLP study, rabbits were exposed to 5000 mg test material/kg bw. No mortality was observed throughout the study. This study was conducted before GLP and guidelines implementation and was only poorly described. Therefore a weight of evidence approach using the supporting substance (EC 422 -320 -3), was deemed more reliable to conclude on this endpoint. This read-across is justified is Iuclid section 13.

Two studies were available on the supporting substance. The two limit acute dermal toxicity studies were performed according to the OECD guideline No. 402 and were in compliance with GLP. Rats (5/sex) were occlusively exposed to undiluted test material for 24 hours at dose of 2000 mg/kg bw. No mortality occurred during the study and no clinical signs were observed. The animals gained the expected weight throughout the whole study period. No macroscopical changes were noted at necropsy. No skin reactions were observed.

The dermal LD50 worst case value, 2000 mg/kg bw, was selected to conclude on this endpoint.

Justification for selection of acute toxicity – oral endpoint
One study was available on the substance but was poorly described (Levenstein, 1974). Therefore, a weight of evidence approach using two reliable studies performed on a supporting substance (EC 422-320-3) (OECD 423 - Chevalier, 2004 & OECD 401 - Chubb, 1992) was selected as the best strategy to conclude on toxicological properties.

Justification for selection of acute toxicity – inhalation endpoint
In accordance with column 2 of REACH Annex VIII (§8.5), the acute toxicity by inhalation does not need to be conducted since the acute toxicity study is already provided for both the oral and the dermal route. Moreover, the vapour pressure of the substance (0.085 Pa at ambient temperature) indicated an absence of volatility and therefore no exposure by inhalation is anticipated. Thus, at ambient temperature, no respiratory absorption is expected under normal use and handling of the substance.

Justification for selection of acute toxicity – dermal endpoint
One study was available on the substance but was poorly described (Levenstein, 1974). Therefore, a weight of evidence approach using two reliable studies performed on the supporting substance (EC 422-320-3) (OECD 402 - Chevalier, 2004 & OECD 402 - Chubb, 1992), was selected as the best strategy to conclude on toxicological properties.

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 including ATP3.

Self classification:

Acute toxicity (Oral):

Based on the available information, the substance is:

- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the oral LD50 is higher than 2000 mg/kg bw

- not classified according to the Annex VI of the Directive 67/548/EEC as the oral LD50 is higher than 2000 mg/kg bw

Acute toxicity (Dermal):

Based on the available information, the substance is:

- not classified according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) as the dermal LD50 is higher than 2000 mg/kg bw

- not classified according to the Annex VI of the Directive 67/548/EEC as the dermal LD50 is higher than 2000 mg/kg bw

Acute toxicity (Inhalation):

This information is not available.

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the Annex VI of the Regulation (EC) No. 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, oral for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value, oral for a Category 2 classification (2000 mg/kg bwc ≥C > 300 mg/kg bw). No classification required.

Specific target organ toxicity: single exposure (Dermal):

The classification criteria according to the Annex VI of the Regulation (EC) No 1272/2008 as specific target organ toxicant (STOT) – single exposure, dermal are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, dermal for a Category 1 classification (C≤ 1000 mg/kg bw) and at the guidance value, dermal for a Category 2 classification (2000 mg/kg bw ≥C > 1000 mg/kg bw). No classification required.

Specific target organ toxicity: single exposure (Inhalation):

This information is not available.