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Administrative data

Description of key information

Acute oral toxicity: LD50 = 2000 mg/Kg

Acute inhalation toxicity: waiving

Acute dermal toxicity: LD50 > 2000 mg/Kg

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:
Sulfosuccine of Lanoline Alcohol is chemically a complex substance. Several studies on Lanoline Alcohol and Sulfosuccinates are reported to indicate the tested toxicity for the different portions of the molecule.

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
Quality of whole database:
Sulfosuccinate of Lanoline Alcohol is chemically a complex substance. Several dermal studies on Lanoline Alcohol and Sulfosuccinates are reported to indicate the tested toxicity for the different portions of the molecule.

Additional information

Sulfosuccinate of Lanoline Alcohol is chemically a complex substance. Several studies on Lanoline Alcohol and sulfosuccinic (represented by two types of sulfosuccinates) are reported to indicate the tested toxicity for the different parts of the molecule.

Lanoline Alcohol portion could be the most involved part in the oral systemic metabolism of the whole substance.

The most conservative value selected from studies indicates no oral toxicity, the LD 50 was determined at 2.000 mg/L.

The inhalation route is not considered appropriate and the test has been waived.

Dermal studies on Lanoline Alcohol and Sulfosuccinates are reported to indicate the tested toxicity for the different parts of the molecule.

The acute dermal median lethal dose (LD50) of Lanoline Alcohol in rat was found to be greater than 2.000 mg/kg body weight.

Justification for selection of acute toxicity – oral endpoint

Sulfosuccinate of Lanoline Alcohol is chemically a complex substance. Lanoline Alcohol could be the  most conservative involved portion in the oral systemic metabolism of the substance. The study was selected due to the most conservative value.

Justification for selection of acute toxicity – inhalation endpoint

According to the Annex VIII of the REACH Regulation n. 1907/2006, inhalation route is not considered appropriate, based also on vapour pressure. Dermal acute toxicity has been tested.

Justification for selection of acute toxicity – dermal endpoint

The study was selected due to the most conservative value.

Justification for classification or non-classification

Oral acute toxicity

The substance Sulfosuccinate of lanolin alcohol is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008:

Oral (mg/kg bodyweight)

Category 1: ATE ≤ 5

Category 2: 5 < ATE≤ 50

Category 3: 50 < ATE≤ 300

Category 4: 300 < ATE≤ 2 000

The value selected for the Lanoline Alcohol is borderline (= 2.000 mg/L) but several supporting studies indicates higher values (range 2.000 - 16.000 mg/Kg). Different Sufosuccinates were also tested, showing acute oral toxicity values >= 2.000 mg/Kg (range 2.000 - 3540 mg/Kg)

Inhalation acute toxicity

According to the Annex VIII of the REACH Regulation n. 1907/2006, inhalation route is not considered appropriate, based also on vapour pressure and the test can be waived.

Dermal acute toxicity

The substance Sulfosuccinate of Lanolin Alcohol is not classified for dermal toxicity because it doesn't meet the classification criteria of the CLP regulation n. 1272/2008:

Dermal (mg/kg bodyweight)

Category 1: ATE ≤ 50

Category 2: 50 < ATE≤ 200

Category 3: 200 < ATE≤ 1000

Category 4: 1000 < ATE≤ 2000

The value selected for the Lanoline Alcohol is > 2.000 mg/Kg.

A representative Sulfosuccinate was also tested, showed acute dermal toxicity values > 5.000 mg/Kg.