Registration Dossier
Registration Dossier
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EC number: 218-259-5 | CAS number: 2095-06-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 23 - August 8, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Optimization test without GLP. Neither OECD guidelines nor GLP (for non-pharmaceuticals) were were in place when the study was performed. The study was perfromed in a GLP lab (for pharmaceuticals) and is well documented. The test system is validated.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Maurer test protocol for optimization test
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study performed before GLP were in place
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- The study have been performed before the REACh legislation enters into force.
Test material
- Reference substance name:
- p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline
- EC Number:
- 225-716-2
- EC Name:
- p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline
- Cas Number:
- 5026-74-4
- Molecular formula:
- C15H19NO4
- IUPAC Name:
- 4-(oxiran-2-ylmethoxy)-N,N-bis(oxiran-2-ylmethyl)aniline
- Test material form:
- liquid: viscous
- Details on test material:
- - Substance type: organic
- Physical state: liquid
- Storage condition of test material: In refrigerator (2-8°C) in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Ltd. Sisseln, Switzerland
- Weight at study initiation: 370 - 460 grams
- Housing: individual caging in type 3 Macrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2 deg C
- Humidity (%): 55 +/-10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10 hours light per day
IN-LIFE DATES: From: To: June 23, 1980 - August 8, 1980
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1%
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1%
- No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- RANGE FINDING TESTS: not reported
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10 intradermal injections in total
- Exposure period: 22 days
- Test groups: 10 animals
- Control group: 10 animals (vehicle)
- Site: right flank (shaven) and on the back for the 1st injection, and on the followwing days a single injection into the back
- Frequency of applications: 3 injections per week, 2 days intervals
- Duration: 22 days induction and 14 days rest period
- Concentrations: 1 (0.1%)
- Adjuvant: Injections during the 2nd and 3rd week were done with a mixture 1:1 of vehicle and complete Freud adjuvant (Bacto).
B. CHALLENGE EXPOSURE
- No. of exposures: 1 intradermal challenge injection and 1 epicutaneous challenge patch
- Day(s) of challenge: 10 days interval between challenge injection and challenge patch
- Exposure period: challenge patch: 24 hours
- Test groups: 1
- Control group: 1
- Site: left flank
- Concentrations: 1 (0.1%)
- Evaluation (hr after challenge): 24 hours - Challenge controls:
- vehicle (propylene glycol) plus 0.1% test material
- Positive control substance(s):
- not required
- Remarks:
- Tests with positive controls have been run periodcally in separate experiments.
Results and discussion
- Positive control results:
- not available
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- none reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: none reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1% in propylene glycol
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- none reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1% in propylene glycol. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: none reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1% in propylene glycol
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- none reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1% in propylene glycol. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: none reported.
Any other information on results incl. tables
Incidence of positive animals per group after intradermal challenge Injection
Negative control group : positive reaction in 2/10 males and 2/10 females => 4/20
Testing group : positive reaction in 5/10 males, and 3/10 females => 8/20
Incidence of positive animals per group after occlusive epicutaneous application
Negative control group : 0/20
Testing group : 20/20
Challenge reactions after occlusive epicutaneous administration of the test material
Animal No. male : 2361 2362 2363 2364 2365 2366 2367 2368 2369 2370
Erythema score (Draize Score)
24 hours after removal of the 2 2 2 2 2 1 2 2 2 2
dressing.
Animal No. female : 2371 2372 2373 2374 2375 2376 2377 2378 2379 2380
Erythema score (Draize Score)
24 hours after removal of the 2 2 2 1 2 2 2 2 2 2
dressing.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions employed, significant differences between the test group and the vehicle-treated controls were only seen after epidermal challenge application of the test material.
The test material is therefore considered to possess skin-sensitizing (contact allergenic) potential in albino-guinea pigs. - Executive summary:
Under the experimental conditions employed, significant differences between the test group and the vehicle-treated controls were only seen after epidermal challenge application of the test material.
The test material is therefore considered to possess skin-sensitizing (contact allergenic) potential in albino-guinea pigs.
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