Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 201-228-5 | CAS number: 79-81-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 October 1988 - 1 December 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD 406 and under GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- other grading scale
- Principles of method if other than guideline:
- In stead of the Magnusson/Kligman grading scale a (other) numerical grading system was used:
- Erythema and eschar formation
0 - No erythema
1 - Slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate erythema
4 - Severe erythema (beet redness) to slight eschar formation (injuries in depth)
- Edema formation
0 - No edema
1 - Slight edema (barely perceptible)
2 - Well-defined edema (edges of area well-defined by definite raising)
3 - Moderate edema (raised approximately 1 millimeter)
4 - Severe edema (raised more than 1 millimeter and extending beyond the area of exposure) - GLP compliance:
- yes
- Remarks:
- with statement of compliance, but without certificate
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Retinyl palmitate
- EC Number:
- 201-228-5
- EC Name:
- Retinyl palmitate
- Cas Number:
- 79-81-2
- Molecular formula:
- C36H60O2
- IUPAC Name:
- (2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraen-1-yl hexadecanoate
- Details on test material:
- - Physical state: Liquid
- Stability under test conditions: 2 hours
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan White spotted (outbred)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Institute of Biomedical Research, CH 4414 Füllinsdorf, Switzerland.
- Age at study initiation: 8 weeks.
- Weight at study initiation: 336 - 378 g.
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding.
- Diet (e.g. ad libitum): Ad libitum, pelleted standard guinea pig breeding/maintenance diet.
- Water (e.g. ad libitum): Ad libitum, community tap water.
- Acclimation period: 1 week under test conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- Induction:
intradermal injection - 5%
epidermal application - 100%
Challenge and re-challenge: 30%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Induction:
intradermal injection - 5%
epidermal application - 100%
Challenge and re-challenge: 30%
- No. of animals per dose:
- 10 control, 20 test substance.
- Details on study design:
- RANGE FINDING TESTS:
PRELIMINARY STUDY
Identification of irritant test article concentrations suitable for the induction phase of the main study.
INTRADERMAL injection:
6 concentrations (0.1, 0.3, 0.5, 1, 3 and 5%) of test article in olive oil injected into the flanks of 2 guinea-pigs. Dermal reactions assessed at 24 hours after injection.
EPIDERMAL application:
(Occlusive) Patches of filter paper (2x2 cm) saturated with 4 concentrations (3, 10, 30 and 100%) of test article in olive oil were applied to the flanks of each of four guinea-pigs. Period of exposure: 24 hours. Dermal reactions were assessed at 0, 24 and 48 hours after removal of patches.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epidermal).
- Exposure period: instant (intradermal) and 48 hours (epidermal).
- Test groups: 1
- Control group: 1
- Site: dorsal skin from the scapular region.
- Frequency of applications: epidermal application one week after intradermal injection.
- Duration: 48 hr (epidermal application)
- Concentrations:
INTRADERMAL (three pairs of injections)
1) Freunds' complete adjuvant 50:50 with distilled water for injection.
2) The test article, dilted to 5% with olive oil.
3) The test article, ate the concentration used in (2), emulsified in a 50:50 mixture of Freunds' complete adjuvant, and the vehicle used in (2).
EPIDERMAL
2x4 cm patch of filter paper saturated with the undiluted free test article (100%).
Reaction sites were assessed for erythema and edema at 0, 24 and 48 hours after removal of patches.
Remark: The control group was treated accordingly with the omission of the test article.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after epidermal induction application.
- Exposure period: approx. 24 hours
- Test groups: 1
- Control group: 1
- Site: left and right flank (5x5 cm area)
- Concentrations:
Treatment and control group (patches, 2x2 cm):
a) non-irritant concentration of test article (30% in olive oil) on left flank.
b) vehicle alone (olive oil) on right flank.
- Evaluation (hr after challenge):
Assessment of sites for erythema and edema at 0, 24 and 48 hours after removal of patch.
OTHER:
C. RE-CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after first challenge.
- Exposure period: approx. 24 hours
- Test groups: 1
- Control group: 1
- Site: left and right flank (5x5 cm area)
- Concentrations:
Treatment group (patches, 2x2 cm):
a) vehicle alone (olive oil) on left flank.
b) non-irritant concentration of test article (30% in olive oil) on right flank.
Control group (patch, 2x2 cm):
a) vehicle alone (olive oil) on left flank.
b) -
- Evaluation (hr after challenge):
Assessment of sites for erythema and edema at 0, 24 and 48 hours after removal of patch. - Challenge controls:
- The control guinea-pigs were challenged in the same way as the substance treated animals. At re-challenge control animals were treated with the vehicle alone.
- Positive control substance(s):
- yes
- Remarks:
- dinitro-chloro-benzene, tested twice a year on a control group as a sensitivity check of the guinea-pig strain (most recent test: September 1988)
Study design: in vivo (LLNA)
- Vehicle:
- other: Not relevant
- Concentration:
- Not relevant
- No. of animals per dose:
- Not relevant
- Details on study design:
- Not relevant
- Statistics:
- Not relevant
Results and discussion
- Positive control results:
- Clear positive testing results were observed in the DNCB treated animals after the epidermal challenge application (September 1988).
10 Dunkin-Hartley albino guinea-pigs (from DUHA Kleintierfarm Madoerin, Switzerland) were used, of which 6 reacted positive and 3 negative (1 diedspontaneously on day 11 of test). This results in a 67% positive reaction.
Induction by 0.5% DNCB in ethanol, challenge by 0.3% DNCB. Substance: DNCB (1-chloro-2,4-dinitro-benzol) from Fluka (Switzerland) frabricated under No. 24440 with a purity of 98%.
Substance possesses a strong skin sensitizing potential according to the test.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Vehicle (olive oil)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Vehicle (olive oil). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle (olive oil)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Vehicle (olive oil). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30% Vitamin-A-Palmitate
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30% Vitamin-A-Palmitate. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30% Vitamin-A-Palmitate
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30% Vitamin-A-Palmitate. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Vehicle (olive oil)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: Vehicle (olive oil). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Vehicle (olive oil)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: Vehicle (olive oil). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% Vitamin-A-Palmitate
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30% Vitamin-A-Palmitate. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% Vitamin-A-Palmitate
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% Vitamin-A-Palmitate. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Vehicle (olive oil)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: Vehicle (olive oil). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle (olive oil)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: Vehicle (olive oil). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Vehicle (olive oil)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: Vehicle (olive oil). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Vehicle (olive oil)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: Vehicle (olive oil). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30% Vitamin-A-Palmitate
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 30% Vitamin-A-Palmitate. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30% Vitamin-A-Palmitate
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 30% Vitamin-A-Palmitate. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Not relevant
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Not relevant
Any other information on results incl. tables
Overview of important test results:
Reading | Hours after challenge | Group | Dose level | No. with + reactions | Total No. in group | Positive reactions (%) | Clinical observations | |
Erythema (E) | Edema (O) | |||||||
2nd reading | 24 | Negative control | Vehicle (olive oil) | 0 | 0 | 10 | 0 | None |
2nd reading | 48 | Negative control | Vehicle (olive oil) | 0 | 0 | 10 | 0 | None |
2nd reading | 24 | Negative control | 30% Vitamin-A-Palmitate | 0 | 0 | 10 | 0 | None |
2nd reading | 48 | Negative control | 30% Vitamin-A-Palmitate | 0 | 0 | 10 | 0 | None |
2nd reading | 24 | Test group | Vehicle (olive oil) | 0 | 0 | 20 | 0 | None |
2nd reading | 48 | Test group | Vehicle (olive oil) | 0 | 0 | 20 | 0 | None |
2nd reading | 24 | Test group | 30% Vitamin-A-Palmitate | 4 | 0 | 20 | 20 | None |
2nd reading | 48 | Test group | 30% Vitamin-A-Palmitate | 2 | 0 | 20 | 10 | None |
Re-challenge | 24 | Negative control | Vehicle (olive oil) | 0 | 0 | 10 | 0 | None |
Re-challenge | 48 | Negative control | Vehicle (olive oil) | 0 | 0 | 10 | 0 | None |
Re-challenge | 24 | Test group | Vehicle (olive oil) | 0 | 0 | 20 | 0 | None |
Re-challenge | 48 | Test group | Vehicle (olive oil) | 0 | 0 | 20 | 0 | None |
Re-challenge | 24 | Test group | 30% Vitamin-A-Palmitate | 0 | 0 | 20 | 0 | None |
Re-challenge | 48 | Test group | 30% Vitamin-A-Palmitate | 0 | 0 | 20 | 0 | None |
In test group after first challenge: 20% (after 24 hours) and 10% (after 48 hours) positively reacting guinea-pigs.
On the rating of allergenicity (see below, Magnusson B. and Kligman A.M. 1969) this means that Vitamin-A-Palmitate 1.7 mIU/g is considered to be of a mild grade in this test.
Sensitization rate (%) | Grade | Classification |
0-8 | 1 | Weak |
9-28 | 2 | Mild |
29-64 | 3 | Moderate |
65-80 | 4 | Strong |
81-100 | 5 | Extreme |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- According to the results described above the allergenic potency of the test article Vitamin-A-Palmitate is considered to be of a mild grade in this test when followed the rating of allergenicity described by Magnusson B. and Kligman A.M. (1969). However, according to the criteria for the classification of a substance as sensitiser as set in Annex VI of EU Directive 67/548/EEC, this test article is not a sensitiser.
- Executive summary:
The purpose of this skin sensitization study was to assess the allergenic potential of Vitamin-A-Palmitate when administered to the skin of male and female albino guinea pigs.
For this purpose the Maximization-Test of B. Magnusson and A.M. Kligman (1969) was used. Ten animals (10 females) were treated with the vehicle alone (i.e. olive oil) and 20 animals (20 females) were treated with the test article.
The study was conducted between October 17th and December 1st, 1988 at the RCC laboratories in 4452 Itingen/Switzerland.
If necessary prior to the first reading of the reactions, the skin was flushed with the vehicle or other solvents to clean the application site from staining produced by the test article, so that the reactions (erythema) were clearly visible at that time.
Results show that in 4 of 20 (20%) Vitamin-A-Palmitate treated guinea-pigs the test was positive 24 hours after first challenge, and 2 of 20 (10%) animals after 48 hours. No positive reactions were observed after second challenge (24 and 48 hours) and in the control group (n=10) after both challenges. No toxic symptoms were evident in the guinea pigs of either the control nor test group. No death occured.
According to the rating of allergenicity described by Magnusson B. and Kligman A.M. (1969), the test article is considered to be of a mild grade. According to the criteria in Annex VI of the EU directive for classification (67/548/EEC), the test article is considered not to be a sensitizer (<30% positive reactions).
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.