Registration Dossier
Registration Dossier
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EC number: 237-360-5 | CAS number: 13762-51-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
- Justification for type of information:
- The study is well documented following general scientific practice.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The hair was removed from the back and flank areas as often as necessary. A solution was injected intracutaneously every other day until a total of 10 had been made. injections were made in the area of the flanks. Two weeks after the tenth injection, a retest injection was made. Twenty-four hours later readings were made.
- GLP compliance:
- no
- Type of study:
- not specified
- Justification for non-LLNA method:
- When the study was conducted, the LLNA-test was not the standard method. As the study is well-documented, it is still considered to be reliable.
Test material
- Reference substance name:
- Sodium tetrahydroborate
- EC Number:
- 241-004-4
- EC Name:
- Sodium tetrahydroborate
- Cas Number:
- 16940-66-2
- Molecular formula:
- BH4.Na
- IUPAC Name:
- Sodium tetrahydridoborate(1–)
- Details on test material:
- - Name of test material (as cited in study report): Sodium borohydride
- Lot/batch No.: 3-117
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 300-400 g
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Twenty-four hours after the 14-day challenge application the skin sensitization score was zero.
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