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EC number: 204-844-2 | CAS number: 127-47-9
- 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 - 2 December 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD guideline 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 used
- Principles of method if other than guideline:
- In stead of the Magnusson/Kligman grading scale an 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
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed before LLNA was formally validated and available as OECD guideline in 2002.
Test material
- Reference substance name:
- Retinyl acetate
- EC Number:
- 204-844-2
- EC Name:
- Retinyl acetate
- Cas Number:
- 127-47-9
- Molecular formula:
- C22H32O2
- 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 acetate
- Details on test material:
- - Name of test material (as cited in study report): Vitamin-A-Acetate
- Physical state: Liquid
- Composition of test material, percentage of components: 1.5 million IU/g (diluted with arachidis oil)
- Stability under test conditions: At least 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: 328 - 386 g
- Housing: Individually in cages
- 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: One 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
IN-LIFE DATES: From: To: 2 December 1988
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- Induction:
- Intradermal: 5%
- Epicutaneous: 30%
Challenge: 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Induction:
- Intradermal: 5%
- Epicutaneous: 30%
Challenge: 10%
- No. of animals per dose:
- Control group: 10
Test article-treated group: 20 - Details on study design:
- RANGE FINDING TESTS:
Intradermal: injections made into shaved flank of two guinea-pigs: 0.1, 0.3, 0.5, 1, 3 and 5% test article in olive oil. Dermal reactions assessed 24 hours later.
Epicutaneous: occlusive patches with 3, 10, 30 and 100% test article in olive oil applied (24 hours) to shaved flanks of each of four guinea-pigs. At 0, 24 and 48 hours after treatment the reactions were assessed.
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 (6x8 cm)
- Frequency of applications: epidermal application one week after intradermal injection
- Concentrations:
INTRADERMAL (three pairs of injections)
1) Freunds' complete adjuvant 50:50 with distilled water for injection.
2) The test article, diluted to 5% with olive oil.
3) The test article at 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 30% test article in olive oil.
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 (10% 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 (10% 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 as sensitivity check (most recent test: September 1988)
Results and discussion
- Positive control results:
- For the induction period a 0.5 % dilution of DNCB in ethanol, and for the challenge procedure a 0.3 % dilution of DNCB was used.
According to the results observed it is considered that DNCB possess a strong skin sensitizing (contact allergenic) potential in the guinea pig strain used (Dunkin-Hartley albino guinea pigs; DUHA KFM. Kleintierfarm Madoerin AG, CH 4414 Fullinsdorf // Switzerland).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 5
- 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: 10%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 5
- 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: 10%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 3
- 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: 10%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 4
- 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: 10%. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- 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. 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
- 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. 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:
- 10%
- 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: 10%. 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:
- 10%
- 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: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
Any other information on results incl. tables
Table 1: | VEHICLE CONTROL | ||||||
SKIN RESPONSE AFTER THE FIRST CHALLENGE PROCEDURE | |||||||
VEHICLE, OLIVE OIL (RIGHT FLANK) | |||||||
Animal Number |
Sex | Erythema/Edema immediately |
readings after 24 hours |
removal of badage 48 hours |
|||
E | O | E | O | E | O | ||
431 | female | 0 | 0 | 0 | 0 | 0 | 0 |
432 | female | 0 | 0 | 0 | 0 | 0 | 0 |
433 | female | 0 | 0 | 0 | 0 | 0 | 0 |
434 | female | 0 | 0 | 0 | 0 | 0 | 0 |
435 | female | 0 | 0 | 0 | 0 | 0 | 0 |
436 | female | 0 | 0 | 0 | 0 | 0 | 0 |
437 | female | 0 | 0 | 0 | 0 | 0 | 0 |
438 | female | 0 | 0 | 0 | 0 | 0 | 0 |
439 | female | 0 | 0 | 0 | 0 | 0 | 0 |
440 | female | 0 | 0 | 0 | 0 | 0 | 0 |
E = Erythema | |||||||
O = Oedema |
Table 2: | VEHICLE CONTROL | ||||||
SKIN RESPONSE AFTER THE FIRST CHALLENGE PROCEDURE | |||||||
TEST ARTICLE-TRATED, 10% IN OLIVE OIL (LEFT FLANK) | |||||||
Animal Number |
Sex | Erythema/Edema immediately |
readings after 24 hours |
removal of badage 48 hours |
|||
E | O | E | O | E | O | ||
431 | female | 0 | 0 | 0 | 0 | 0 | 0 |
432 | female | 1 | 0 | 1 | 0 | 1 | 0 |
433 | female | 1 | 0 | 1 | 0 | 1 | 0 |
434 | female | 1 | 0 | 1 | 0 | 1 | 0 |
435 | female | 0 | 0 | 0 | 0 | 0 | 0 |
436 | female | 0 | 0 | 0 | 0 | 0 | 0 |
437 | female | 1 | 0 | 1 | 0 | 1 | 0 |
438 | female | 0 | 0 | 0 | 0 | 0 | 0 |
439 | female | 0 | 0 | 0 | 0 | 0 | 0 |
440 | female | 1 | 0 | 1 | 0 | 1 | 0 |
Table 3: | TEST ARTICLE GROUP | ||||||
SKIN RESPONSE AFTER THE FIRST CHALLENGE PROCEDURE | |||||||
VEHICLE, OLIVE OIL (RIGHT FLANK) | |||||||
Animal Number |
Sex | Erythema/Edema immediately |
readings after 24 hours |
removal of badage 48 hours |
|||
E | O | E | O | E | O | ||
441 | female | 0 | 0 | 0 | 0 | 0 | 0 |
442 | female | 0 | 0 | 0 | 0 | 0 | 0 |
443 | female | 0 | 0 | 0 | 0 | 0 | 0 |
444 | female | 0 | 0 | 0 | 0 | 0 | 0 |
445 | female | 0 | 0 | 0 | 0 | 0 | 0 |
446 | female | 0 | 0 | 0 | 0 | 0 | 0 |
447 | female | 0 | 0 | 0 | 0 | 0 | 0 |
448 | female | 0 | 0 | 0 | 0 | 0 | 0 |
449 | female | 0 | 0 | 0 | 0 | 0 | 0 |
450 | female | 0 | 0 | 0 | 0 | 0 | 0 |
451 | female | 0 | 0 | 0 | 0 | 0 | 0 |
452 | female | 0 | 0 | 0 | 0 | 0 | 0 |
453 | female | 0 | 0 | 0 | 0 | 0 | 0 |
454 | female | 0 | 0 | 0 | 0 | 0 | 0 |
455 | female | 0 | 0 | 0 | 0 | 0 | 0 |
456 | female | 0 | 0 | 0 | 0 | 0 | 0 |
457 | female | 0 | 0 | 0 | 0 | 0 | 0 |
458 | female | 0 | 0 | 0 | 0 | 0 | 0 |
459 | female | 0 | 0 | 0 | 0 | 0 | 0 |
460 | female | 0 | 0 | 0 | 0 | 0 | 0 |
Table 4: | TEST ARTICLE GROUP | ||||||
SKIN RESPONSE AFTER THE FIRST CHALLENGE PROCEDURE | |||||||
TEST ARTICLE-TREATED, 10% IN OLIVE OIL (LEFT FLANK) | |||||||
Animal Number |
Sex | Erythema/Edema immediately |
readings after 24 hours |
removal of badage 48 hours |
|||
E | O | E | O | E | O | ||
441 | female | 0 | 0 | 0 | 0 | 0 | 0 |
442 | female | 0 | 0 | 0 | 0 | 0 | 0 |
443 | female | 0 | 0 | 0 | 0 | 0 | 0 |
444 | female | 0 | 0 | 0 | 0 | 0 | 0 |
445 | female | 0 | 0 | 0 | 0 | 0 | 0 |
446 | female | 0 | 0 | 1 | 0 | 1 | 0 |
447 | female | 0 | 0 | 0 | 0 | 0 | 0 |
448 | female | 0 | 0 | 0 | 0 | 0 | 0 |
449 | female | 0 | 0 | 0 | 0 | 0 | 0 |
450 | female | 0 | 0 | 0 | 0 | 0 | 0 |
451 | female | 1 | 0 | 0 | 0 | 0 | 0 |
452 | female | 0 | 0 | 0 | 0 | 0 | 0 |
453 | female | 0 | 0 | 0 | 0 | 0 | 0 |
454 | female | 0 | 0 | 0 | 0 | 0 | 0 |
455 | female | 1 | 0 | 0 | 0 | 0 | 0 |
456 | female | 1 | 0 | 1 | 0 | 0 | 0 |
457 | female | 0 | 0 | 1 | 0 | 1 | 0 |
458 | female | 0 | 0 | 0 | 0 | 1 | 0 |
459 | female | 0 | 0 | 0 | 0 | 0 | 0 |
460 | female | 0 | 0 | 0 | 0 | 1 | 0 |
Both the negative control and article-treated group respond positive to a challenge with vitamin-A-acetate. This indicates that the substance is rather irritating than sensitizing. At re-challenge, none of the animals reacts positively to the test substance.
Considering the article-treated group, 3 and 4 out of 20 animals responded positively at challenge: this is 15-20%. 50% of the controls (5 out of 10) responded positive to the substance.
In accordance with the OECD-guidelines, a rechallenge was performed to clarify the results (as also mentioned in the REACH guidance on Information Requirements). As no skin reactions were noted at the rechallenge, the results of the test can be used for classification.
Table 5:
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-Acetate 1.5 millionIU/g is considered to be of a mild to moderate grade in this test when followed the rating of allergenicity described by Magnusson B. and Kligman A.M. (1969).
According to EEC (European Economic Community) classification criteria described in guidelines 83/467, September 16, 1984 however, this test article is not a sensitiser. - Executive summary:
In this skin sensitization study Vitamin-A-Acetate 1.5 millionIU/g was used at concentrations of 5% for intradermal and 30% for epicutaneous induction. After the first challenge with 10% test article, 20% of experimental and 50% of control animals showed skin responses, while no skin reactions were noted after rechallenge.
According to the data of this study it can be concluded that Vitamin-A-Acetate 1.5 millionIU/g possesses slight allergenic potential for guinea pigs. It can be assumed that occasional or intended and conditioned exposure of the human skin to this test article will, with high probability, be harmless for human health.
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