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:
- other: EU Risk Assessment report
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Although the EU risk assessment report is secondary literature, all data and risk assessment for the human, health and the environment have been evaluated and reviewed by Finland prior to publication. The risk assessment report has been submitted to final approval and published in the Official Journal of the European Union C157/10 dated on 21.06.2008. Thus, it is considered the information reported are reliable with the restrictions that reliability of the data presented has not been assessed again.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- European Union Risk Assessment 2,3-epoxypropyltrimethylammonium chloride CAS RN 3033-77-0 Einecs No: 221-221-0
- Author:
- EC
- Year:
- 2 008
- Bibliographic source:
- Risk Assessment. Final approved version. Rapporteur: Finland (FIN). European communities. Printed in Italy. 147pp
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- 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
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Vaeseline
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaeseline
- No. of animals per dose:
- 20 guinea-pigs/group
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2: one intradermal exposure and one topical exposure
- Exposure period: 3 weeks
- Test groups:
- Control group: yes
- Site: dorsal area
- Frequency of applications: one week after the intradermal injection
- Duration: 48 hours for topical exposure
- Concentrations: 5% of the test substance in water for the intradermal injection and 5% in vaseline for the topical induction
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after first topical induction
- Exposure period: 24 hours
- Test groups:
- Control group: yes
- Site: dorsol area
- Concentrations: 2.5% test substance in vaseline
- Evaluation (hr after challenge): 24 and 48 hours after challenge - Challenge controls:
- Controls were treated with vaseline only.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- test chemical
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- erythema, immediately after challenge
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. No with. + reactions: 11.0. Total no. in groups: 20.0. Clinical observations: erythema, immediately after challenge.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of erythema.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the test conditions, EPTAC is classified as skin sensitiser according to the criteria of the Annex VI to the CLP Regulation (EC) N°1272/2008 and to the criteria of the Annex VI to the Directive 67/548/EEC.
- Executive summary:
In a dermal sensitization study, equivalent to a OECD 406 guideline, EPTAC was tested in guinea-pigs using the Maximisation Test method (20 animals treated and 20 controls).
EPTAC diluted at 5% in vaseline was administered by intradermal injection. Topical induction was performed with EPTAC diluted at 5% in vaseline. EPTAC was tested at 2.5% for the challenge.
In the topical induction phase, there was slight erythema noted after 24 hours.
Dermal reactions were observed in 14 of the 20 guinea-pigs treated and no reactions have been observed in the control animals.More than 30% of the animal tested showed positive reactions.
Therefore, under the test conditions, EPTAC is classified as a skin sensitizer according to the criteria of the Annex VI to the CLP Regulation (EC) N° 1272/2008 and to the criteria of the Annex VI to the Directive 67/548/EEC.
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