Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-290-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- challenge utilized Kodak foot pad method, which utilized a vehicle containing acetone+dioxane+guinea pig fat (7:2:1)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted prior to the introduction of the LLNA as a validated test method
Test material
- Reference substance name:
- Sucrose di(acetate) hexaisobutyrate
- EC Number:
- 204-771-6
- EC Name:
- Sucrose di(acetate) hexaisobutyrate
- Cas Number:
- 126-13-6
- IUPAC Name:
- Sucrose Acetate Isobutyrate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone+dioxane+guinea pig fat (7:2:1)
- Concentration / amount:
- 1% (induction); 10% (challenge)
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: acetone+dioxane+guinea pig fat (7:2:1)
- Concentration / amount:
- 1% (induction); 10% (challenge)
- No. of animals per dose:
- 10
- Details on study design:
- A 1% soluton of SAIB was prepared in Freund's Complete Adjuvant (FCA) and was applied topically to shaved skin of 10 guinea pigs, which was followed by an occlusive dressing. Ten control guinea pigs were treated similarly with FCA without SAIB.
- Challenge controls:
- vehicle controls
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- slight erythema in 5 of 10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: slight erythema in 5 of 10 animals.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- slight erythema in 6 of 10 animals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: slight erythema in 6 of 10 animals.
- Key result
- Reading:
- other: not measured
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- No positive group kept
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- Not measured
- Remarks on result:
- not measured/tested
- Remarks:
- Not measured
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test article, sucrose diacetate hexaisobutyrate (SAIB) has a low potential to cause human skin sensitization
- Executive summary:
Sucrose diacetate hexaisobutyrate (SAIB) was evaluated for its potential for dermal sensitization in guinea pigs, using the Kodak foot pad method. When a challenge concentration of 10% SAIB in the solvent vehicle was administered topically, alight erythema at the exposure site was notnd on five of ten irritation control animals and on six of ten animals previously induced with SAIB. No reaction was observed at challenge in any of the remaining animals in either group. Base on aimiliar reactions observed at challenge
between the group of animals previously induced with Freund' a adjuvant and the group of animals induced with the test article in
Freund's adjuvant, the test article was not considered a akin sensitizer. SAIB is considered to have a low potential to cause human skin sensitization.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
