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Registration Dossier
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EC number: 939-180-9 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Equivalent to EU method B.6. No data on GLP.
Data source
Reference
- Reference Type:
- publication
- Title:
- Étude expérimentale du pouvoir sensibilisant d´un échantillonnage de polyaziridines
- Author:
- Zissu D
- Year:
- 2 003
- Bibliographic source:
- Cahiers de Notes Documentaires - Hygiène et sécurité du travail, No. 193, 19-21.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- Magnusson and Kligman maximisation test
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An appropriate guinea pig maximisation test is available which would not justify conducting an additional LLNA due to animal welfare.
Test material
- Reference substance name:
- 64264-57-2
- IUPAC Name:
- 64264-57-2
- Details on test material:
- Nº1: purity 99%
Nº2: purity >99%
Nº3: purity 99%
Nº4: purity 96%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 350 g
- Housing: The animals were housed individually in polypropylene cages
- Diet (e.g. ad libitum): Sterilized granules (UAR 114); ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 ± 1 ºC
- Humidity (%): 50 ± 5%
- Air changes (per hr): 15 cycles/hour
- Photoperiod (hrs dark / hrs light): light - dark cycle 12 h:12 h
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Concentration / amount:
- Nº1:
Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water)
Nº2:
Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water)
Nº3:
Induction: 0.5 and 3 % p/v (in propylene glycol)
Challenge: 0.5 % p/v (in propylene glycol)
Nº4:
Induction: 0.3 and 1 % p/v (in water)
Challenge: 1 % p/v (in water)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Concentration / amount:
- Nº1:
Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water)
Nº2:
Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water)
Nº3:
Induction: 0.5 and 3 % p/v (in propylene glycol)
Challenge: 0.5 % p/v (in propylene glycol)
Nº4:
Induction: 0.3 and 1 % p/v (in water)
Challenge: 1 % p/v (in water)
- No. of animals per dose:
- Treatment: 20 animals
Control: 10 animals - Details on study design:
- RANGE FINDING TESTS:
The concentrations used in the main study were established in a preliminary study to determine the lowest concentrations producing low irritation for the induction phase and the highest non irritant concentrations for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
Day 1:
Three pairs of intradermal injections of 0.1 ml are given in the shoulder region.
Injection 1: the test substance in an appropriate vehicle at the selected concentration
Injection 2: a 1:1 mixture (v/v) FCA/physiological saline
Injection 3: the test substance at the selected concentration formulated in a 1:1 mixture (v/v) FCA/physiological saline.
Day 8: The substance is applied to the treated area (occlusive) at a slightly irritant concentration for 48 hours.
The control group is treated with the vehicle and FCA following the same conditions as for the treated group.
B. CHALLENGE EXPOSURE
- Day(s) of challenge: Day 22
- Exposure period: 24 h
- Concentrations: 0.5 ml of the test substance at the highest non irritant concentration (occlusive)
- Evaluation (hr after challenge): 24 and 48 h - Positive control substance(s):
- yes
- Remarks:
- (α-hexylcinnamaldehyde (HCA), CAS No. 101-86-0)
Results and discussion
- Positive control results:
- The percentage of animals showing a positive response was 31% (6/19).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water) - No. with + reactions:
- 13
- Total no. in group:
- 20
- Remarks on result:
- other: Test group Nº1
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 1 and 3 % p/v (in water)
Challenge: 0.5 % p/v (in water) - No. with + reactions:
- 18
- Total no. in group:
- 20
- Remarks on result:
- other: Test group Nº2
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 0.5 and 3 % p/v (in propylene glycol)
Challenge: 0.5 % p/v (in propylene glycol) - No. with + reactions:
- 12
- Total no. in group:
- 19
- Remarks on result:
- other: Test group Nº3
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 0.3 and 1 % p/v (in water)
Challenge: 1 % p/v (in water) - No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- other: Test group Nº4
Any other information on results incl. tables
The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups. The substance is considered to be a skin sensitiser.
- Executive summary:
A Magnusson and Kligman maximisation test was performed to determine the sensitising potential of the test substance.
The percentage of animals showing a positive response after treatment with the test substance was ≥35% in all the test groups. The substance is considered to be a skin sensitiser.
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