Registration Dossier
Registration Dossier
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EC number: 290-844-8 | CAS number: 90268-43-2
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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