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EC number: 810-472-7 | CAS number: 159325-45-8
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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.
- 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.
Reference
| 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.
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).
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