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EC number: 701-024-0 | CAS number: 26038-87-9
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Full study but only available as a letter report.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Guinea pig test was already available.
Test material
- Reference substance name:
- MEA-Polyborate 1:3
- IUPAC Name:
- MEA-Polyborate 1:3
- Details on test material:
- - Name of test material (as cited in study report):
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:EU-SMG01696
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- No data
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1 and 0.3% liquid boron in water
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.1 and 0.3% liquid boron in water
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Site: Dorsum overlying the scapulae
- Frequency of applications: Once
- Concentrations: 0.1 ml per site
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 and 48 hours
- Site: Right flank
- Concentrations: 0.3. 0.1% liquid boron in water
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.3%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.3%. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Group:
- negative control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- It was concluded that MEA Polyborate 1:3 135 g/L was practically devoid of potential to cause sensitisation.
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