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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 268-084-3 | CAS number: 68002-71-1 This substance is identified by SDA Substance Name: C16-C18 trialkyl glyceride and SDA Reporting Number: 19-001-00.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Not available
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
- Principles of method if other than guideline:
- Skin sensitization potential of fully hydrogenated coconut oil was determined in guinea pigs using Buehler method.
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Conducted prior to the mandate of in vitro test requirement
Test material
- Reference substance name:
- Glycerides, C8-18 and C18-unsatd.
- EC Number:
- 266-946-3
- EC Name:
- Glycerides, C8-18 and C18-unsatd.
- Cas Number:
- 67701-28-4
- Molecular formula:
- Triglycerides containing a glycerol backbone esterified to fatty acids with a carbon chain length of C8-18 as well as unsaturated C18 fatty acids
- IUPAC Name:
- Tri(C8-18 and C18-unsatd. fatty acyl)glycerol
- Details on test material:
- - Name of test material (as cited in study report): Fully hydrogenated coconut oil (CAS N° 84836-98-6, EC N° 284-283-8); under the SDA nomenclature, the name of this substance is ‘Glycerides, C8-18 and C18-unsatd.’
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- No data
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 95% ethyl alcohol
- Concentration / amount:
- 5%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 95% ethyl alcohol
- Concentration / amount:
- 5%
- No. of animals per dose:
- 15 in test group and 5 in control group
- Details on study design:
- RANGE FINDING TESTS: The primary irritation threshold for fully hydrogenated coconut oil was found to be 5% in ethyl alcohol, which produced slight irritation upon repeated application.
MAIN STUDY
A. INDUCTION EXPOSURE
An occlusive Webril pad containing 0.5 ml of the 5% fully hydrogenated coconut oil in ethyl alcohol was applied for 6 h to the shaved backs. This procedure was repeated three times weekly for a total of nine induction applications.
B. CHALLENGE EXPOSURE
Two weeks after the last prechallenge application, all animals were challenged topically on untreated sites with the same procedure for application and dosage employed previously. Skin reactions were graded 24 h after the challenge. - Challenge controls:
- Same treatment as used for test group but using only the vehicle
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- Not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: No details provided
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the test conditions, the substance was found to be non-sensitizing to guinea-pig skin.
- Executive summary:
A study was conducted to determine the skin sensitisation potential of ‘Glycerides,
C8-18 and C18-unsatd.’ (as fully hydrogenated coconut oil) in guinea pigs according to the Buehler method.An occlusive Webril pad containing 0.5 mL of 5% substance in ethyl alcohol was applied for 6 h to the shaved backs of 15 guinea pigs. This procedure was repeated three times weekly for a total of nine induction applications. A control group of 5 animals was subjected to the same treatment using only the vehicle, 95% ethyl alcohol. Two weeks after the last prechallenge application, all animals were challenged topically and skin reactions were graded after 24 h. No animals developed skin responses significantly greater than the controls.
Under the test conditions, the substance was found to be nonsensitizing to guinea-pig skin (CIR, 1986).
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.
