Registration Dossier
Registration Dossier
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EC number: 221-221-0 | CAS number: 3033-77-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: EU Risk Assessment report
- Adequacy of study:
- other information
- Study period:
- No data
- 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-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other 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
- Principles of method if other than guideline:
- No detail about the methodology used for the experiment
- GLP compliance:
- no
- Remarks:
- Study performed before GLP establishment
- Test type:
- fixed dose procedure
- Limit test:
- no
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:
- no detail
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Details on dermal exposure:
- no detail
- Duration of exposure:
- no data
- Doses:
- 1500 or 3000 mg/kg
- No. of animals per sex per dose:
- 3 animals/dose
- Control animals:
- not specified
- Details on study design:
- no detail
- Statistics:
- no data
Results and discussion
- Preliminary study:
- no data
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- >= 1 500 - <= 3 000 mg/kg bw
- Based on:
- not specified
- Mortality:
- In the lower dose group (1500 mg/kg), 1/3 animal died after 7 days of administration.
In the higher dose group, 2/3 animals died after 5h or 2 days of administration. - Clinical signs:
- other: No data
- Gross pathology:
- No data
- Other findings:
- No other findings
Any other information on results incl. tables
No other information
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Considering the lower limit of the range dermal LD50 (1500 mg/kg bw), EPTAC is classified as Acute tox. 4 (H312, harmful in contact with skin) according to the CLP regulation (No. 1272/2008 EC) and as harmful in contact with skin (Xn, R21) according to the Directive 67/548/EEC.
- Executive summary:
In a dermal acute study (Shellengberger, 1962), two groups of three rabbits each were administered dermally either 1500 or 3000 mg/kg 2,3-Epoxypropyltrimetylammonium Chloride (EPTAC) in an aqueous solution. There was no information about the methodology used to expose the animals to the test substance (duration, type of patch).
In the lower dose group (i.e.1500 mg/kg bw) one rabbit died after 7 days of administration whereas in the higher dose group (i.e.3000 mg/kg bw), two rabbits died in 5 h or 2 days. The LD50was estimated to be between 1500 – 3000 mg/kg bw.
Considering the lower limit of the range dermal LD50(1500 mg/kg bw), EPTAC is classified as Acute tox. 4 (H312, harmful in contact with skin) according to the CLP regulation (No. 1272/2008 EC) and as harmful in contact with skin (Xn, R21) according to the Directive 67/548/EEC.
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