Registration Dossier

Administrative data

Description of key information

The acute oral toxicity test used for read-across was performed on a structural analogue . The study was performed according to OECD Short-term and Long-term toxicology groups and WHO pubblication: Environmental Health criteria 6, Principles and method for evaluating the toxicity of chemicals, part 1, Geneva 1979. 
The acute dermal toxicity was investigated on the substance "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite" according to OECD guideline 402, EPA OPPTS 870.1200 (Acute Dermal Toxicity) and EC 440/2008, following GLP conditions.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

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
2 000 mg/kg bw

Additional information

The acute oral toxicity test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows clearly that the substance is not toxic (LD50 > 5000 mg/kg b.w.) .

The acute dermal toxicity test was performed in the year 2011, under GLP conditions and following the OECD guidelines. Under the conditions of the study, neither mortality nor signs of toxicity but minor signs of irritation were observed.

The dermal LD50 was determined to be > 2000 mg / kg body weight (based on the active components).


Justification for selection of acute toxicity – oral endpoint
The study refers to "D-Glucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts", a structurally related substance to "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite". The acute oral toxicity test, performed in the year 1993, did not follow the OECD. However the conditions applied in the study are acceptable and the result shows clearly that the substance is not toxic.

Justification for selection of acute toxicity – dermal endpoint
Study was performed with "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite". The study was carried out in GLP and according to an OECD standard method.

Justification for classification or non-classification

Basing on the results above reported and following the REGULATION (EC) No 1272/2008 (EU Regulation on Classification, Labelling and Packaging of substances and mixtures) the substance "Sulfonation products of (esterification products of C9-11 (branched and linear) alkyl-(mono-, di- and tri-)glycosides with maleic anhydride) with dipotassium sulfite" does not required classification for acute toxicity.

 

Oral Toxicity:

Classification : not required

Signal word : none

Hazard statement (Oral) : none

 

Dermal toxicity

Classification : Not required

Signal word : None

Hazard statement : None