Registration Dossier
Registration Dossier
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EC number: 221-221-0 | CAS number: 3033-77-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1981-04-28 to 1981-05-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study equivalent to the guideline study, conducted without GLP, meeting generally accepted scientific principles and acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2,3-epoxypropyltrimethylammonium chloride
- EC Number:
- 221-221-0
- EC Name:
- 2,3-epoxypropyltrimethylammonium chloride
- Cas Number:
- 3033-77-0
- Molecular formula:
- C6H14NO.Cl
- IUPAC Name:
- N,N,N-trimethyl(oxiran-2-yl)methanaminium chloride
- Details on test material:
- Test substance: Quab 151, approx. 72 % aqueous solution
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: SPF-bred albino (no further details)
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: TNO. Central Institute for the breeding of laboratory animals, Zeist, NETHERLANDS
- Age at study initiation: -
- Weight at study initiation: 232-322 g
- Housing: -
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 1 day
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23+/-1 (OECD 406 recommends 20 +/- 3; the conditions might slightly exceed those recommended)
- Humidity (%): >=40% (OECD 406 recommends 30-70%; the conditions could exceed those recommended)
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1981-04-28 To: 1981-05-23
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: intradermal: water; epicutaneous: vaseline
- Concentration / amount:
- induction:
intradermal - 5%
epicutaneous - 5%
challenge: 2.5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: intradermal: water; epicutaneous: vaseline
- Concentration / amount:
- induction:
intradermal - 5%
epicutaneous - 5%
challenge: 2.5%
- No. of animals per dose:
- 20 test, 20 control
- Details on study design:
- 1st application: Induction 5 % intracutaneous
2nd application: Challenge 5 % occlusive epicutaneous
3rd application: Challenge 2.5 % occlusive epicutaneous - Challenge controls:
- Controls challenged in same manner as test animals.
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No positive control results presented
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. Dose level: 2.5%. No with. + reactions: 11.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 14.0. Total no. in groups: 20.0.
- Reading:
- other: all readings 0, 24, 48 h after challenge
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: all readings 0, 24, 48 h after challenge. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
In the topical induction phase, there was very slight erythema noted after 24 hours in 7 animals.
The challenge results showed erythema in 11 (55%) animals straight after the 24 -h challenge and in 14 (70%) animals 24 hours later. At 48 h after challenge, 3 still showed a skin reaction. There were no responses in any control animal at any time point.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- A guinea-pig maximisation test conducted without GLP or positive controls but otherwise in a manner similar to the standard guideline reported 70% response to challenge with the test substance. A response of 30% or more in an adjuvant test indicates sensitization.
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