Registration Dossier

Administrative data

Description of key information

No information is available on sucrose benzoate regarding sensitisation.

As a worst case scenario read-across to data on benzoic acid can be used. This is considered as a precautious approach as sucrose benzoate is a non-reactive chemcial substance having  a low water solubility (3 mg/L) and high molacular weight (1175 g/mol) and thus considered to have a much lower potential for dermal penetration than benzoic acid.

See also read-across justification attached in section 13.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
No information is available on sucrose benzoate. As a worst case scenario read across to benzoic acid can be used. This is considered as a precautious approach as sucrose benzoate is a non-reactive chemcial substance having a low water solubility (3mg/L) and high molacular weight (1175 g/mol) and thus considered to have a much lower potential for dermal penetration than benzoic acid.
See also read-across justification attached in section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Species:
mouse
Strain:
CBA:J
Sex:
female
Key result
Parameter:
other:
Value:
0
Test group / Remarks:
not indicated
Remarks on result:
other: negative, the substance is not a skin sensitiser
Remarks:
negative, the substance is not a skin sensitiser
Interpretation of results:
GHS criteria not met
Conclusions:
No information is available on sucrose benzoate. As a worst case scenario read across to benzoic acid can be used. For benzoic acid several sensitisation studies including LLNA, GPMT and Buehler tests revealed no sensitising potential of the substance. Based on this RAC concluded on no classification regarding skin sensitisation for benzoic acid (ECHA/RAC 2012).
Neither benzoic acid nor sucrose are of concern in relation to skin sensitisation. So even in a worst case situation with some hydrolysis and liberation of benzoic acid, sucrose benzoate can be concluded as non sensitising as well.
Executive summary:

No information is available on sucrose benzoate. As a worst case scenario read across to benzoic acid can be used. For benzoic acid several sensitisation studies including LLNA, GPMT and Buehler tests revealed no sensitising potential of the substance. Based on this RAC concluded on no classification regarding skin sensitisation for benzoic acid (ECHA/RAC 2012).

Neither benzoic acid nor sucrose are of concern in relation to skin sensitisation. So even in a worst case situation with some hydrolysis and liberation of benzoic acid sucrose benzoate can be concluded as non sensitising as well.

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No information is available on sucrose benzoate. As a worst case scenario read across to benzoic acid can be used. For benzoic acid several sensitisation studies including LLNA, GPMT and Buehler tests revealed no sensitising potential of the substance. Based on this RAC concluded on no classification regarding skin sensitisation for benzoic acid (ECHA/RAC 2012).

Thus, neither benzoic acid nor sucrose are of concern in relation to skin sensitisation. So even in a worst case situation with some hydrolysis and liberation of benzoic acid, sucrose benzoate can be concluded as non sensitising as well.

Justification for classification or non-classification

Based on read-across to data on benzoic acid, it can be concluded that sucrose benzoate does not have a potential for skin sensitisation. Thus, no classification according to the CLP-criteria applies for this end-point.