Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
in vitro
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 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Deviations:
yes
Principles of method if other than guideline:
Standard protocol n°CEPC.B.ETU.PRO.EPI.04
Study of cytotoxicity on reconstituted epiderm by quantification of different endpoints (MTT, LDH, IL1a and IL8)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
pentyl 6-deoxy-alpha-L-mannopyranoside
EC Number:
700-713-3
Cas Number:
83161-22-2
Molecular formula:
C11H22O5
IUPAC Name:
pentyl 6-deoxy-alpha-L-mannopyranoside
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.

Test animals

Details on test animals or test system and environmental conditions:
test in vitro on reconstituted epiderm

Test system

Type of coverage:
other: in vitro test
Vehicle:
other: water/glycerol mixture
Controls:
yes
Amount / concentration applied:
APRC5 30%
Duration of treatment / exposure:
72h
Observation period:
72h
Details on study design:
test item : APRC5 30%
positive control item : Triton 4%

Results and discussion

In vivo

Results
Irritation parameter:
other: in vitro pamameters (LDH, IL1a, IL8)
Remarks on result:
other: slighly irritant
Irritant / corrosive response data:
 

Any other information on results incl. tables

 

   Test item  Positive control item
24h exposure  MTT % viability  89.9
24h exposure  LDH ratio

 1.4

 124.7
24h exposure  IL1a ratio  2.4  36
24h exposure  IL8 ratio  5.2 3.7 
72h exposure  MTT % viability  82.1  1.5
72h exposure  LDH ratio  1  77.3
72h exposure  IL1a ratio  2  7.2
72h exposure  IL8 ratio  4  0.9
 Classification    Slighly irritant  Irritant
     
       
       
       
       
       
       
       

Applicant's summary and conclusion

Conclusions:
slightly irritating