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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD methode used

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
yes
Remarks:
Temporary deviation from minimum relative humidity
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 98,9%

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
Conditions: 15 air changes/hr, Temp. range: 20.0-23.3°C, Relative humidity: 37-83%, Light: 12hrs artificial fluorescent light/12 hrs darkness per day
Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF Spezialdiäten GmbH, Soest, Germany)
Water: free access to tap water.

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
0, 10, 25 and 50%
No. of animals per dose:
5 per group
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: 0%: 1,0 10%: 1,4 25%: 0,8 50%: 1,0
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Median DPM: 0%: 252 10%: 245 25%: 343 50%: 202

Any other information on results incl. tables

DPM - individual data and calculations    
group/animal nrs an 1-5 an 6-10 an 11-15 an 16-20  
Concentration * vehicle 10% 25% 50%  
  232 300 343 647  
  619 349 391 196  
  803 245 175 202  
  207 237 518 462  
  252 169 220 195  
DPM mean 423 260 329 340  
sem 121 30 61 92  
Concentration vehicle 10 25 50  
SI** mean 1,0 0,6 0,8 0,8  
sem 0,4 0,2 0,3 0,3  
           
DPM median 252 245 343 202  
SI median 1,0 1,0 1,4 0,8  

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The SI values calculated for the substance concentrations 10, 25 and 50% were 1.0, 1.4 and 0.8 respectively.
Since there was no indication that the test substance elicit an SI larger or equal to 3 when tested up to 50%, 4B-Acid was considered to be a non skin sensitizer