Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 November 1997 to 1 January 1998
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 6 weeks old
- Weight at study initiation: Less than 500 grams
- Housing: Metal cages with wire-mesh floors
- Diet: Free access to standard guinea pig diet, including ascorbic acid (1600 mg/kg); LC 23-B, pellet diameter 4 mm (Hope farms, Woerden, The Netherlands).
- Water: Free access to tap water, diluted with decalcified water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50%
- Air changes (per hr): 15/hours
- Photoperiod (hrs dark / hrs light): 12/12 - artificial fluorescent light

IN-LIFE DATES: From: 09 November 1997 To: 1 January 1998
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Induction: 1%, 2%, and 50%;

Challenge: 50%
Route:
epicutaneous, semiocclusive
Vehicle:
corn oil
Concentration / amount:
Induction: 1%, 2%, and 50%;

Challenge: 50%
No. of animals per dose:
10
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: 10 days
- Test groups: 10 animals
- Control group: 5 animals
- Site: Scapular region
- Frequency of applications: Day 1, Day 7 and Day 8
- Duration: 48 hours - Day 8
- Concentrations: 1%, 2%, and 50%

B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 22 and Day 23
- Exposure period: 24 hours
- Test groups: 10 animals
- Control group: 5 animals
- Site: Scapular region
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 hours

OTHER:
Challenge controls:
Vehicle - corn oil
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Moderate to intense erythema and swelling
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Moderate to intense erythema and swelling.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
Moderate to intense erythema and swelling
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Moderate to intense erythema and swelling.

Challenge  
Animal No. Day 24 Day 25 Comments  
 50%# Vehicle 50% Vehicle  
 Control              
66 0 0 0 0  
67 0 0 0 0  
68 0 0 0 0  
69 0 0 0 0  
70 0 0 0 0  
 
Experimental  
71 3 0 4n 2 Sensitised  
72 3 0 4n 0 Sensitised  
73 4n 0 4s 1 Sensitised  
74 3 0 3n 2 Sensitised  
75 3 0 4n 0 Sensitised  
76 3 0 3n 0 Sensitised  
77 4n 0 4s 0 Sensitised  
78 2 0 3s 0 Sensitised  
79 2 0 3n 0 Sensitised  
80 2 0 2 0 Sensitised  

#. Test substance concentration

n. Signs of necrosis

s. Eschar formation.

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study it can be concluded that the test substance would be considered a sensitisation agent.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Under the conditions of this study, epyrron caused sensitization following dermal exposure of guinea pigs.


Migrated from Short description of key information:
Under the conditions of this study, epyrron caused sensitization following dermal exposure of guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Epyrron is classified as a sensitizer according to Directive 67/548/EEC and according to Regulation (EC) 1272/2008 (CLP).