Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 Aug 2014 - 24 Nov 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: ElmSam:HA
Sex:
male
Details on test animals and environmental conditions:
Temperature : (20.5-22.8)℃
Relative humidity : (49.0-57.7)% R.H.
Air exchange : (10-20)/h
Light cycle : Light 12h(08:00-20:00)
Dark 12h(20:00-08:00)
Illumination : (150-300)Lux
Cage style : Stainless steel wire cage
Quarantine cage size : (700W x 475D x 200H) mm
Experiment cage size : (540W x 610D x 200H)mm
Animal per cage : Less than 5

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 80% Ethanol
Concentration / amount:
Concentrations:
INDUCTION
Treatment : 25%(w/v) test substance
Negative control : 80% Ethanol
Positive control : 1%(w/v) DNCB
CHALLENGE:
Treatment : 25%(w/v) test substance
Negative control : 25%(w/v) test substance
Positive control : 1%(w/v) DNCB
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 80% Ethanol
Concentration / amount:
Concentrations:
INDUCTION
Treatment : 25%(w/v) test substance
Negative control : 80% Ethanol
Positive control : 1%(w/v) DNCB
CHALLENGE:
Treatment : 25%(w/v) test substance
Negative control : 25%(w/v) test substance
Positive control : 1%(w/v) DNCB
No. of animals per dose:
Treatment : 20
Negative control : 10
Positive control : 10
Details on study design:
Induction exposure
- No. of exposure : 3
- Exposure period : 6h
- Test groups : 3
- Site : The fur on one flank [(4*6)cm2]
- Frequency of application : day 0, 7, 14
- Duration : induction period continues to day 21
- Observation : Approximately 21hours after removing the patch of the challenge area
Challenge controls:
Induction exposure
- No. of exposure : 1
- Exposure period : 6h
- Test groups : 3
- Site : The untreated flank of treated and control animals
- Frequency of application : day 27
- Duration : induction period continues to day 29
- Observation : Approximately 21hours after removing the patch of the challenge area
Positive control substance(s):
yes
Remarks:
1-chloro-2,4-dinitrobenzene(DNCB)

Results and discussion

Positive control results:
See table 1, below.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
25%(w/v) test substance in Ethanol
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%(w/v) test substance in Ethanol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
25%(w/v) test substance in Ethanol
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%(w/v) test substance in Ethanol. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%(w/v) test substance in Ethanol
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%(w/v) test substance in Ethanol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%(w/v) test substance in Ethanol
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%(w/v) test substance in Ethanol. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
1%(w/v) DNCB in Ethanol
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%(w/v) DNCB in Ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
1%(w/v) DNCB in Ethanol
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1%(w/v) DNCB in Ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: no.

Any other information on results incl. tables

Table 1. Evaluation of skin reaction

 Group Number of animals  Observation time  Score of skin reaction           Mean score Semsotosatopm rate(%) 
       0 1    
Test substance group  20  24  20* 0.0  0.0 
     48  20 0.0  0.0 
 Negative control  10  24  10 0.0  0.0 
     48  10 0 0 0 0.0  0.0 
Positive control  10  24 1 5 4 0 1.3  90.0 
     48 2 7 1 0 0.9  80.0 

* : Number of animals showing the score

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
These results indicate that this test substance is considered to have no skin sensitizing potency of Red 620 in guinea pigs by Buehler test under the conditions of this study.