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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-668-1 | CAS number: 26402-26-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- November 12th, 1984 - April 18th, 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: 79(831/EWG, Annex V, Part B)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- , lack of details on test substance and lack of positive control data.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed before REACH inforcement.
Test material
- Reference substance name:
- Glycerides, C16-18 and C18-hydroxy mono- and di-
- EC Number:
- 295-191-2
- EC Name:
- Glycerides, C16-18 and C18-hydroxy mono- and di-
- Cas Number:
- 91845-19-1
- Molecular formula:
- C51H98O6; C57H110O6 C57H110O9; C57H110O12
- Reference substance name:
- Glyceride, C16-18- und C18-Hydroxymono- und Di-
- IUPAC Name:
- Glyceride, C16-18- und C18-Hydroxymono- und Di-
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: no data
- Weight at study initiation: mean: 312 g (test group) and 303 (control group)
- Housing: Makrolon Type IV, 5 animals per cage
- Diet (e.g. ad libitum): Altromin Diet 3032 DK, Lage, Germany.
- Water (e.g. ad libitum): tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 50-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: paraffin oil (1%) for intradermal application and vaseline (50%) for epicutaneous application
- Concentration / amount:
- induction: 50%
challenge: 25 % in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: paraffin oil (1%) for intradermal application and vaseline (50%) for epicutaneous application
- Concentration / amount:
- induction: 50%
challenge: 25 % in vaseline
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
3 preliminary tests were performed with 5 animals each:
For the intradermal induction a 1% concentration of test substance in vaseline induced sufficient skin irritation.
For the epidermal induction a 50% concentration of test substance in vaseline was determined as the minimal irritating concentration.
To be able to determine the maximum non-irritating concentration for challenge treatment, intracutaneous injections of 0.1 mL FCA bilaterally of the vertebral column were made. 2 weeks later 25% and 50% test substance concentrations were applied for 24 h under plaster-covering. A 25% concentration was found to be the maximum non-irritating concentrations.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: 2nd induction: 48 h (epicutaneous exposure)
- Test groups: 20 animals, TS (intracutaneously: FCA alone (cranial application), TS in FCA, TS in vehicle, epicutaneously: 1 week after intradermal induction, occlusive conditions)
- Control group: 20, vehicle only
- Site: 1. induction: Interscapular region, 2nd induction on the same site as 1st induction
- Frequency of applications: 1st induction on day 0, 2nd induction on day 7
- Concentrations: 1% for intradermal induction, 50 % for topical induction
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the 2nd induction
- Exposure period: 24 hours
- Test groups: 20, TS
- Control group: 20, TS
- Site: right flank, occlusive conditions
- Concentrations: 25 % (0.2 g application volume)
- Evaluation (hr after challenge): 24 and 48 hours after exposure - Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities observed.
- Reading:
- other: Reliabilty
- Group:
- positive control
- Remarks on result:
- other: no data available
Any other information on results incl. tables
Individual results were not given in tabulated form, as all skin examination were negative, both at 24 and 48 hours after challenge exposure. None of the animals showed abnormalities in clinical observations and body weight gain.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information to guinea pig skin
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.
