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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
Qualifier:
according to guideline
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 chemical
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 chemical
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).