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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Objective of study:
- distribution
- Principles of method if other than guideline:
- The aim of the study was to determine the bioavailability of four stabilized products of Vitamin A acetate using the liver accumulation test.
Male and female Sprague-Dawley rats, depleted of vitamin A, were administered the different products in the diet for 7 and 14 days and the Vitamin A content in liver was determined.
and the vitamin A level of their livers was determined. - GLP compliance:
- no
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:
- Four commercial samples of stabilised Vitamin A acetate (CAS No. 127-47-9):
- substance codes: 78/337 and C1
Vitamin A Acetate dry powder 500000 IE: Vitamin A acetate
(500000 IU/g, ca. 170 mg/g or 17%); matrix: gelatin,
glucose, corn starch
manufacturer: BASF AG
- substance codes: 78/338 and C2
Microvit A 750 Super: Vitamin A acetate; 750000 IU/g (ca.
260 mg/g or 26%); matrix: gelatin, dextrin, lactose,
glycerol
manufacturer: external supplier
- substance codes: 78/339 and C3
Vitamin A Acetate dry powder 650000 IE: Vitamin A acetate
(650000 IU/g, ca. 220 mg/g or 22%); matrix: gelatin,
glucose, corn starch
manufacturer: BASF AG
- substance codes: 78/340 and C4
Vitamin A Acetate 650000 IE: Vitamin A acetate (650000
IU/g, ca. 220 mg/g or 22%); matrix: gelatin, sugar,
modified starch
manufacturer: external supplier
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Wiga, Sulzfeld
- Housing: individual housing in Typ D2/3 cages
- Diet : ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-5
- Photoperiod (hrs dark / hrs light):12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: in feed
- Details on exposure:
- Male and female Sprague-Dawley rats depleted of vitamin A were
administered the different products in the diet for 7 and 14 days. - Duration and frequency of treatment / exposure:
- diet for 7 and 14 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Approx. 1.7 - 2.6 ppm in the diet (5670 - 7640 IU/kg diet)
- No. of animals per sex per dose / concentration:
- Males: 80 Females: 80
- Control animals:
- no
- Positive control reference chemical:
- not applicable
- Details on study design:
- Pregnant rats were administered normal diet until day 15 of gestation. Thereafter, the rats were offered vitamin-A-depleted diet until weanling
of their pups. The livers of 25 neonates were analysed for vitamin A content. One hundred male and 100 female weanlings were fed
vitamin-A-depleted diets until the onset of clinical signs of vitamin-A-deficiency. Following parameters were determined:
- Body weight/ body weight gain
- Food consumption
- Mortality/ clinical signs of toxicity
- Vitamin A concentration in the liver
Thereafter, the rats were allocated to 8 groups of 10/sex and fed the different samples of vitamin A acetate as indicated in the table (see freetext ). Groups 1-4 and 5-8 were treated for 7 and 14 days, respectively. The following parameters were determined for each animal:
- body weight / body weight gain
- food consumption during exposure
- Mortality/ clinical signs of toxicity
- gross pathology
- organ weight of liver, heart, kidneys, spleen, testes
- skeletal assessment by X ray
- Vitamin A concentration in the liver - Statistics:
- statistical evaluation (t-test and Duncan test);
statistical significance was set at p = 0.05 and p = 0.01.
Results and discussion
Toxicokinetic / pharmacokinetic studies
Transfer into organs
- Transfer type:
- other: accumulation in liver
- Observation:
- distinct transfer
Metabolite characterisation studies
- Metabolites identified:
- no
Any other information on results incl. tables
General results:
================
Body weight, body weight gain and food consumption was unaffected. During the
period of vitamin A depletion (feeding of a vitamin A deficient diet), signs
indicative of a hypovitaminosis (swollen eyelids and swollen limbs) were
observed. These symptoms were reversible within the first days of vitamin A
feeding. No animal died during the test period. Gross pathology revealed no
alterations of the internal organs and skeleton.
The ranking of Vitamin A resorption from the four products was as follows:
Microvit A 750 Super (external supplier), substance code C2 > Vitamin A Acetate
dry powder 500000 IE (BASF), substance code C1 = Vitamin A Acetate dry powder
650000 IE (BASF), substance code C3 > Vitamin A Acetate 650000 IE (external
supplier), substance code C4.
Details of the statistical evaluation:
======================================
Comparison of 7-day and 14-day exposure:
----------------------------------------
The following changes were observed for the different vitamin A compounds,
regarding the vitamin A concentration per gram liver after 14 days compared to
those after 7-day exposure:
substance code C1 (groups 1 and 5):
vitamin A content after 14 days less than 2-fold those after 7 days
substance code C2 (groups 2 and 6):
vitamin A content after 14 days approximately 2-fold those after 7 days
substance code C3 (groups 3 and 7):
vitamin A content after 14 days approximately 3-fold those after 7 days in
males and approximately 2-fold those after 7 days in females
substance code C4 (groups 4 and 8):
vitamin A content after 14 days approximately 3-fold those after 7 days
Tables 1-4:
-----------
FOOD CONSUMPTION, LIVER WEIGHT, AND BODY WEIGHT of males and females after 7
and 14 days of exposure. Values are given as mean +/- standard deviation (SD),
mean of n = 10.
Table 1: 7-day exposure, males
group food cons. liver wt. body wt.
no. [g] [g] [g]
---------------------------------------------------------
1 145.1+/-8.87 11.71+/-1.276 264.4+/-16.10
2 151.1+/-9.32 11.57+/-1.181 268.1+/-18.48
3 150.3+/-12.08 11.27+/-1.294 365.5+/-21.14
4 146.4+/-13.06 11.15+/-1.568 364.8+/-20.80
Table 2: 7-day exposure, females
group food cons. liver wt. body wt.
no. [g] [g] [g]
---------------------------------------------------------
1 113.1+/-8.30 7.48+/-0.630 189.4+/-11.09
2 115.7+/-9.32 7.47+/-0.517 190.8+/-12.79
3 115.6+/-9.51 7.41+/-0.630 191.6+/-11.05
4 116.3+/-10.38 7.39+/-0.628 191.8+/-9.75
Table 3: 14-day exposure, males
group food cons. liver wt. body wt.
no. [g] [g] [g]
---------------------------------------------------------
5 295.5+/-17.85 11.89+/-1.252 298.2+/-23.47
6 303.5+/-23.49 12.57+/-1.633 302.8+/-21.85
7 288.5+/-28.41 11.58+/-1.723 294.4+/-28.89
8 298.6+/-13.04 12.25+/-1.130 298.4+/-18.31
Table 4: 14-day exposure, females
group food cons. liver wt. body wt.
no. [g] [g] [g]
---------------------------------------------------------
5 239.0+/-13.16 7.66+/-0.835 207.6+/-8.77
6 240.3+/-19.70 7.81+/-0.943 206.3+/-16.01
7 226.4+/-17.40 7.65+/-0.979 205.2+/-16.51
8 227-2+/-11.63 7.96+/-0.805 205.4+/-9.17
Tables 5-8:
-----------
VITAMIN A CONCENTRATIONS in the livers of males and females, both after 7 and
14 days of feeding.
The parameter "Vit. A [IE/g liver]" (3rd column) is defined as IE vitamin
A per 1 gram of liver (remark: 1 IE = 0.344 ug vitamin A acetate).
The parameter "% Vit. A" (4th column) is defined as Vitamin A in liver per
Vitamin in food consumption * 100.
All values are given as mean +/- standard deviation (SD), mean of n = 10.
Table 5: 7-day exposure, males
group subst. Vit A % Vit A
no. code [IE/g liver]
-------------------------------------------------------
1 C1 37.8 +/- 12.84 53.4 +/- 17.91
2 C2 50.6 +/- 6.88 54.3 +/- 5.25
3 C3 28.1 +/- 10.53 28.0 +/- 8.63
4 C4 24.0 +/- 8.78 26.1 +/- 10.39
Table 6: 7-day exposure, females
group subst. Vit A % Vit A
no. code [IE/g liver]
-------------------------------------------------------
1 C1 46.5 +/- 13.10 54.2 +/- 15.55
2 C2 67.1 +/- 13.03 61.0 +/- 11.49
3 C3 48.3 +/- 13.43 41.0 +/- 10.06
4 C4 29.3 +/- 10.76 26.0 +/- 9.36
Table 7: 14-day exposure, males
group subst. Vit A % Vit A
no. code [IE/g liver]
-------------------------------------------------------
5 C1 56.6 +/- 12.03 42.1 +/- 10.09
6 C2 106.8 +/- 9.48 62.0 +/- 5.38
7 C3 83.7 +/- 15.43 45.8 +/- 9.18
8 C4 69.4 +/- 8.33 40.5 +/- 4.99
Table 8: 14-day exposure, females
group subst. Vit A % Vit A
no. code [IE/g liver]
-------------------------------------------------------
5 C1 91.9 +/- 24.24 45.8 +/- 11.96
6 C2 130.3 +/- 23.13 59.3 +/- 9.00
7 C3 93.7 +/- 19.22 40.9 +/- 7.44
8 C4 93.0 +/- 10.30 46.1 +/- 4.34
Applicant's summary and conclusion
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.
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