Registration Dossier
Registration Dossier
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EC number: 424-650-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 31 July 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed at a time when the LLNA assay was not a validated or approved OECD/EU method for regulatory acceptance. This study was performed under an OECD/EC guideline with GLP-compliance. On the grounds of animal welfare and under REACH, it would not be acceptable to repeat this study using another in vivo method (namely the LLNA).
Test material
- Reference substance name:
- Donor C20
- IUPAC Name:
- Donor C20
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: ca. 3 weeks
- Weight at study initiation: not specified
- Housing: moblie battery, containing 6 cages; max. 10 animals per cage
- Diet (e.g. ad libitum): standard laboratory diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 45 - 82.5%
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12h dark / 12h light
Study design: in vivo (non-LLNA)
- Details on study design:
- RANGE FINDING TESTS:
The irritation response to intradermal injection of various concentrations of the test substance was examined in 3 guinea pigs. A sufficiently large area of the flanks was clipped free from hair with electric clippers. Amounts of 0.1mL of the selected concentrations were applied by intradermal injection. A concentration causing slight to moderate irritation but other well-tolerated by the animals, is usually used in the induction phase of the main study.
The irritation response to topical treatments of various concentrations of the test substance was examined in 3 guinea pigs. A sufficiently large area of the flanks was clipped free from hair with electric clippers. Patches were loaded with the test material and placed on the clipped skin of each animal and covered by elastic adhesive bandage, wound around the torso of the animal. The dressing was left in place for 24 hours. 24 and 48 hours after removal the animals were examined for skin irritation. A concentration causing slight to moderate skin irritation is usually chosen for topical induction and a non-irritant concentration for topical challenge
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6 test sites per animal
- Exposure period: 48 hour (topical application)
- Test groups: 1 (5 males and 5 females, selected at random)
- Control group: 1 (3 males and 3 females, selected at random)
- Site: dorsal skin of the scapular region
- Frequency of applications: intradermal injection, followed by topical application after 7 days
- Concentrations: 3% intradermal injection in maize oil; 30% topical application
- Additional information: 10% dilution of sodium lauryl sulfate in vasline was applied to the skin on the day before the topical application of the test substance to enhance sensitivity of the skin (no irritation seen at any concentration in the preliminary study).
B. CHALLENGE EXPOSURE
- No. of exposures: 6 test sites per animal
- Day(s) of challenge: 3 days in (exposure plus observation period)
- Exposure period: 24 hours
- Test groups: : 1 (5 males and 5 females, selected at random)
- Control group: 1 (3 males and 3 females, selected at random)
- Site: Site: dorsal skin of the scapular region
- Concentrations: 30% in maize oil
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches
- Challenge controls:
- Concurrent, 30% maize oil in topical application
- Positive control substance(s):
- yes
- Remarks:
- formaldehyde (historical control data from 1996)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% dilution in maize oil
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% dilution in maize oil
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30% dilution in maize oil
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30% dilution in maize oil
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- not measured/tested
- Remarks:
- no concurrent positive control was run in this study
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 30 %
Signs of irritation during induction:
Very slight erythema was observed after the topical
induction (in test and control animals).
Other observations:
All animals remained in good health during the experimental
period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was not sensitising to skin in a guinea pig maximisation test.
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