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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 619-079-3 | CAS number: 949109-75-5
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to current OECD test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Not applicable-UVCB
- EC Number:
- 619-079-3
- Cas Number:
- 949109-75-5
- Molecular formula:
- UVCB- Mixture of many formulae.
- IUPAC Name:
- Not applicable-UVCB
- Reference substance name:
- Steroids, hydroxy
- EC Number:
- 271-413-3
- EC Name:
- Steroids, hydroxy
- Cas Number:
- 68555-08-8
- IUPAC Name:
- 68555-08-8
- Test material form:
- other: Solid
- Details on test material:
- - Name of test material (as cited in study report): Generol 122. This substance is known by CAS number 68555-08-8. It fits the substance identity of the registered substance
- Substance type: Phytosterol UVCB
- Typical composition: beta-sitosterol (EC 201-480-6) 30-80%; campesterol (EC 207-484-4) ≤ 45%; Stigmasterol (EC 201-482-7) ≤ 30%; brassicasterol (EC 207-486-5) ≤ 20%; sitostanol (EC 201-479-0) ≤ 15%; campestanol (CAS 474-60-2) ≤ 2%
- Physical state: solid (at room temperature)
- Analytical purity: 95-100% Plant sterols
- Purity test date: not given
- Lot/batch No.:1055
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- Application dose - 0.65 g/plaster
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- Application dose - 0.65 g/plaster
- No. of animals per dose:
- 3 preliminary, 10 control; 5 dose finding;
20 treatment.group
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12% dilution
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- First challenge - Slight/weak dermal effects on the flank 24 hours after challenge.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 12% dilution. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: First challenge - Slight/weak dermal effects on the flank 24 hours after challenge..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 12% dilution
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- First challenge - Slight dermal reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 12% dilution. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: First challenge - Slight dermal reaction.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12% dilution
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Clinical observations:
- First challenge - Slight to weak dermal reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 12% dilution. No with. + reactions: 17.0. Total no. in groups: 20.0. Clinical observations: First challenge - Slight to weak dermal reaction.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 12% dilution
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- First challenge - Slight to weak dermal effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 12% dilution. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: First challenge - Slight to weak dermal effects.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 12% dilution
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- First challenge - Slight dermal reaction
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 12% dilution. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: First challenge - Slight dermal reaction.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 12% dilution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- First challenge - no effects reported
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 12% dilution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: First challenge - no effects reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3% dilution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Second challenge - no effects reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3% dilution. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Second challenge - no effects reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3% dilution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Second challenge - no dermal effects reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 3% dilution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Second challenge - no dermal effects reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Clinical observations:
- Second challenge - slight dermal reaction
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: Second challenge - slight dermal reaction.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3% dilution
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- Second challenge - slight dermal reaction
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 3% dilution. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Second challenge - slight dermal reaction.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 3% dilution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Second challenge - no dermal effects reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 3% dilution. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Second challenge - no dermal effects reported.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 3% dilution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Second challenge - no dermal effects reported
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 3% dilution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Second challenge - no dermal effects reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- In a well conducted skin sensitisation study using non adjuvant method (Buehler,OECD 406, Rel 1, GLP) Plant sterols did not show any responses in guinea pigs following induction and challenge (epicutaneous, occlusive method). Plant sterols therefore do not fall under the criteria of classification as per EU Regulation CLP. (1272/2008)
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.
