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Diss Factsheets

Administrative data

Description of key information

Skin sensitisation in vivo (OECD 406, Buehler): not sensitising

Read-across from structural analogue source substance D-Glucopyranose, oligomers, hexyl glycosides (CAS 54549-24-5)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to analogue justification report provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
One animal was found dead on Day 22.
Remarks on result:
other: Source, 54549-24-5, Safepharm Laboratories, 1998a
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Source, 54549-24-5, Safepharm Laboratories, 1998a
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
75%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
One animal was found dead on Day 22.
Remarks on result:
other: Source, 54549-24-5, Safepharm Laboratories, 1998a
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Source, 54549-24-5, Safepharm Laboratories, 1998a
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
One animal was found dead on Day 22.
Remarks on result:
other: Source, 54549-24-5, Safepharm Laboratories, 1998a
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Source, 54549-24-5, Safepharm Laboratories, 1998a
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
One animal was found dead on Day 22.
Remarks on result:
other: Source, 54549-24-5, Safepharm Laboratories, 1998a
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Source, 54549-24-5, Safepharm Laboratories, 1998a
Key result
Group:
positive control
Remarks on result:
other: summary of historical positive control data appended to study report
Remarks:
Source, 54549-24-5, Safepharm Laboratories, 1998
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
Based on the results of a Buehler test conducted with a structurally analogue substance, the target substance is not expected to be a skin sensitiser.
Executive summary:

The skin sensitisation potential of the target substance is estimated based on an adequate and reliable in vivo study from a structural analogue source substance. In the study following the Buehler test design, no skin sensitisation was observed following occlusive epicutaneous challenge after induction treatments (occlusive epicutaneous exposure). Therefore, based on read-across, for the target substance no hazard regarding skin sensitisation is expected.. As explained in the analogue justification, the differences in molecular structure between the target and the source substance are unlikely to lead to differences in the skin sensitisation potential.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Based on the results of a Buehler test conducted with a structurally analogue substance, D-Glucopyranose, oligomeric, pentyl glycosides (CAS 100231-63-8) is not expected to be a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation from an adequate analogue substance do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP). Data are, therefore, conclusive but not sufficient for classification. Based on read-across, D-Glucopyranose, oligomeric, pentyl glycosides (CAS 100231-63-8) is also considered not to meet the criteria for classification for skin sensitisation. No data regarding respiratory sensitisation are available.