Registration Dossier
Registration Dossier
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EC number: 246-805-2 | CAS number: 25306-75-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Sodium hydroxide is both reagents used in the manufacture of sodium O-isobutyl dithiocarbonate . Therefore, sodium hydroxide need to be considered in the assessment of sodium O-isobutyl dithiocarbonate
Data source
Reference
- Reference Type:
- publication
- Title:
- A study of skin responses to follow-up, rechallenge and combined effects of irritants using non-invasive measurements
- Author:
- Park et al.
- Year:
- 1 995
- Bibliographic source:
- Journal of Dermatological Science, 10, 159-165
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Patch testing for 24 hours with visual scoring being recorded by the subjective evaluation method and by the transepidermal water loss method. After the seventh day reading sodium hydroxide (0.125%) was re-applied to all pretested sites and reading was performed on the next day.
- GLP compliance:
- not specified
- Type of study:
- not specified
- Justification for non-LLNA method:
- Patch testing for 24 hours with visual scoring being recorded by the subjective evaluation method and by the transepidermal water loss method. After the seventh day reading sodium hydroxide (0.125%) was re-applied to all pretested sites and reading was performed on the next day.
The irritant response was well correlated to the concentration of the irritant.
Test material
- Reference substance name:
- Sodium O-isobutyl dithiocarbonate
- EC Number:
- 246-805-2
- EC Name:
- Sodium O-isobutyl dithiocarbonate
- Cas Number:
- 25306-75-6
- Molecular formula:
- C5H10OS2.Na
- IUPAC Name:
- sodium [(2-methylpropoxy)methanethioyl]sulfanide
- Test material form:
- solid: bulk
- Details on test material:
- SIBX/Sodium O-isobutyl dithiocarbonate is produced by the reaction of an isobutyl alcohol with sodium hydroxide to form alcoholate and subsequently adding carbon disulfide to form SIBX/ Sodium O-isobutyl dithiocarbonate.
SIBX/Sodium O-isobutyl dithiocarbonate contains 2-methylpropan-1-ol l/isobutyl alcohol (CAS number 78-83-1) and sodium hydroxide (CAS number 1310-73-2) which are an integral part of the substance.
2-methylpropan-1-ol l/ isobutyl alcohol (CAS number 78-83-1) and sodium hydroxide (CAS number 1310-73-2) are both reagents used in the manufacture of SIBX/Sodium O-isobutyl dithiocarbonate. Therefore, 2-methylpropan-1-ol l/ isobutyl alcohol (CAS number 78-83-1) and sodium hydroxide (CAS number 1310-73-2) need to be considered in the assessment of SIBX/Sodium O-isobutyl dithiocarbonate.
CAS name: isobutyl alcohol
EC / List name: 2-methylpropan-1-ol
IUPAC name: 2-methylpropan-1-ol
EC / List no.: 201-148-0
CAS no.: 78-83-1
CAS name: sodium hydroxide
EC / List name: Sodium hydroxide
IUPAC name: sodium hydroxide
EC / List no.: 215-185-5
CAS no.: 1310-73-2
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- HUMAN VOLUNTEERS
- Age at study initiation: between 20 and 25
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- Concentrations used for induction: 50 µl, 1.0, 0.5, 0.25, 0.125 and 0.063%
Challengeopen allclose all
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- Concentrations used for induction: 50 µl, 1.0, 0.5, 0.25, 0.125 and 0.063%
- No. of animals per dose:
- Number of volunteers: 15 without any previous history of atopy
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- Control group: yes, distilled water and empty chambers
- Site: back
- Duration: 24 hours (induction and challenge)
- Concentrations: 50 µl, 1.0, 0.5, 0.25, 0.125 and 0.063%
B. CHALLENGE EXPOSURE
- No. of exposures: on day 7, NaOH was reapplied
- Day(s) of challenge: 1
- Concentrations: 0.125% - 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:
- 50 µl, 1.0, 0.5, 0.25, 0.125 and 0.063%
- Total no. in group:
- 15
- Clinical observations:
- The irritant response was well correlated to the concentration of the irritant. However, increased response was not observed when subclinical doses were rechallenged on the previously patch tested sites.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 µl, 1.0, 0.5, 0.25, 0.125 and 0.063%. Total no. in groups: 15.0. Clinical observations: The irritant response was well correlated to the concentration of the irritant. However, increased response was not observed when subclinical doses were rechallenged on the previously patch tested sites..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 µl, 1.0, 0.5, 0.25, 0.125 and 0.063%
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50 µl, 1.0, 0.5, 0.25, 0.125 and 0.063%
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
The irritant response was well correlated to the concentration of the irritant. However, increased response was not observed when subclinical doses were rechallenged on the previously patch tested sites.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Sodium hydroxide is both reagents used in the manufacture of sodium O-isobutyl dithiocarbonate . Therefore, sodium hydroxide need to be considered in the assessment of sodium O-isobutyl dithiocarbonate
The irritant response was well correlated to the concentration of the irritant. However, increased response was not observed when subclinical doses were rechallenged on the previously patch tested sites.
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