Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013-11-14 to 2013-11-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Carried out under GLP conditions and under OECD and EU methods.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Deviations:
no
GLP compliance:
yes
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Storage condition of test material: room temperature until 14 October 2013 then approximately 4 °C in the dark

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK
- Age at study initiation: eight to twelve weeks old
- Weight at study initiation: 15 to 23 g
- Housing: individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet
- Water (e.g. ad libitum): Free access to mains tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:
dimethylformamide
Concentration:
50% , 25% or 10% w/w
No. of animals per dose:
4
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: Soluble
- Irritation: No signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: A mean ear thickness increase of equal to or greater than 25% was considered to indicate excessive irritation and limited biological relevance to the endpoint of sensitization.

Results and discussion

Positive control results:
None

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Concentration (% w/w) in dimethyl formamide - Stimulation Index - Result 10 9.18 Positive 25 12.07 Positive 50 9.62 Positive
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Concentration (% w/w) in dimethyl formamide - dpm - dpm/Node a - Stimulation Index b - Result 21515.04 2689.38 na na 10 197450.90 24681.36 9.18 Positive 25 259725.20 32465.65 12.07 Positive 50 207039.40 25879.93 9.62 Positive

Any other information on results incl. tables

Disintegrations per minute

Concentration (% w/w) in dimethyl formamide

 

 

dpm

 

 

dpm/Node a

 

 

Stimulation Index b

 

 

Result

 

Vehicle

 

21515.04

 

2689.38

 

na

 

na

 

10

 

197450.90

 

24681.36

 

9.18

 

Positive

 

25

 

259725.20

 

32465.65

 

12.07

 

Positive

 

50

 

207039.40

 

25879.93

 

9.62

 

Positive

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was considered to be a sensitizer under the conditions of the test.
Executive summary:

.