Absolute of Nicotiana tabacum (Solanaceae) obtained from leaves by organic solvent treatment and subsequent ethanol extraction

Endpoint summary

Description of key information

- Oral LD50 > 5000 mg/kg bw (K, Rel.2)

- Dermal LD50 > 5000 mg/kg bw (WoE, Rel.2)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Only basic data given in the available study. However, no death out of ten animals was observed at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 401/423/425. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint.

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:

5 000 mg/kg bw

Quality of whole database:

Only basic data given in the available studies. However, it was considered sufficiently robust to cover this endpoint.

Additional information

Acute toxicity: via oral route:

A key study was identified (Moreno, 1976, Rel. 2). In this limit acute oral toxicity study, 10 rats were administered a single oral dose of test material of 5000 mg/kg bw. The animals were observed for mortality and clinical signs for 14 days.

No mortality occurred during the study. No clinical signs related to the administration of the test item were observed during the study.

Oral LD50 > 5000 mg/kg bw

 

Acute toxicity: via dermal route:

Two studies are available and considered as WoE (Moreno, 1976, Rel.2):

- In an acute dermal toxicity study (limit test), two rabbits were given a single dermal application of the test material at a dose level of 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.

No mortality occurred during the study. No clinical signs were observed. Moderate redness was observed in two animals, slight edema in one rabbit and moderate edema in another.

- In an acute dermal toxicity study (limit test), ten guinea-pigs were given a single dermal application of the test material at a dose level of 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days. One mortality occurred during the study. No clinical signs were observed. Slight redness was observed in four animals and slight edema in another one.

Dermal LD50 > 5000 mg/kg bw

 

Justification for classification or non-classification

 

Harmonized classification:

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

 

Self classification:

Acute toxicity (Oral):

Based on the available information, the substance is:

- not classified according to the CLP and to the GHS as the oral LD50 is higher than 5000 mg/kg bw

 

Acute toxicity (Dermal):

Based on the available information, the substance is:

- not classified according to the CLP and to the GHS as the dermal LD50 is higher than 5000 mg/kg bw

 

Acute toxicity (Inhalation):

No information was available. Not required for substances at the REACH Annex VII tonnage level.

 

Specific target organ toxicity: single exposure (Oral):

The classification criteria according to the CLP and to the GHS 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 bw≥C > 300 mg/kg bw). No classification is required.

The criteria for Transient Organ effects (STOT-SE Category 3) according to the CLP and to the GHS are not met since narcotic effects were not observed in the acute oral toxicity study.

 

Specific target organ toxicity: single exposure (Dermal):

The classification criteria according to the CLP and to the GHS 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 is required.

The criteria for Transient Organ effects (STOT-SE Category 3) according to Annex I of the Regulation (EC) No. 1272/2008 are not met since narcotic effects were not observed in the acute dermal toxicity study.

 

Specific target organ toxicity: single exposure (Inhalation):

No information was available. Not required for substances at the REACH Annex VII tonnage level.

 

Aspiration hazard:

The substance is not a hydrocarbon and no effects were observed on lungs in oral studies, therefore the criteria for aspiration toxicity according to the CLP and to the GHS are not met.