Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
(2S,3R,4R,5R,6R)-2-methyl-6-(pentyloxy)oxane-3,4,5-triol
EC Number:
700-713-3
Cas Number:
83161-22-2
Molecular formula:
C11H22O5
IUPAC Name:
(2S,3R,4R,5R,6R)-2-methyl-6-(pentyloxy)oxane-3,4,5-triol
Details on test material:
For technical reason (solubility), APRC5 was diluted at 30% in a water/glycerol (1/5) mixture
This mixture corresponds to the industrial form.

In vivo test system

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Positive control substance(s):
yes
Remarks:
DNCB

Study design: in vivo (LLNA)

Vehicle:
other: water/glycerol mixture
Concentration:
Tested concentrations : 3, 15 and 30%
No. of animals per dose:
no data
Positive control substance(s):
other: DNCB

Results and discussion

In vivo (LLNA)

Results
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: See results table below

Any other information on results incl. tables

 0  3%  15%  30%
 DPM-Blanc  13814.5  9921.5  8328.5  6378.5
 DPM/Glanglion  1726.8  1240.2  1041.1  797.3
 Ratio  -  0.7  0.6 0.5 
 Classification  -  no sensitisation   no sensitisation  no sensitisation 

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
APRC5 is not sensitising