D-Xylopyranose, oligomeric, 2-octyldodecyl xylosides

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Applicant's summary and conclusion

Executive summary:

The dermal toxicity study for D-Xylopyranoside, 2-octyldodecyl was not performed based on other scientific information available.According to REACH guidance R.7.a, chapter. 7.4 Acute toxicity, study does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).

In the oral acute toxicity experimental study (see section 7.2.1),

The LD50 oral was rat > 2000 mg/kg no treatment-related macroscopic findings were observed and no mortality was observed 

This shows that the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route.

In the OECD 404: (see section 7.3.1 Skin irritation):

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. Loss of skin elasticity was also noted at two treated skin sites. One treated skin site appeared normal at the 72-hour observation and the remaining two treated skin sites appeared normal at the 7-day observation.No systemic effects have been observed in in vivo studies with dermal exposure.

In the OECD 406: (see section 7.4.1 (Skin Sensitisation):

No macroscopic cutaneous reactions attributable to allergy was recorded during the examination following the removal of the occlusive dressing (challenge phase) from the animals of the treated group with the test product. No cutaneous intolerance reaction was recorded in animals from the negative control group.

Conclusion:

In view of these results, under these experimental conditions,no systemic effects have been observed in in vivo studies with dermal exposure

 The test material did not meet the criteria for classification as sensitisation according to the EU labelling regulations Commission Directive 2001/59/EC.