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EC number: 230-636-6 | CAS number: 7235-40-7
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2006-06-14 to 2006-07-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study performed under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- β,β-carotene
- EC Number:
- 230-636-6
- EC Name:
- β,β-carotene
- Cas Number:
- 7235-40-7
- Molecular formula:
- C40H56
- IUPAC Name:
- β,β-carotene
- Details on test material:
- - Name of test material (as cited in study report): beta carotene, technical grade
- Physical state: dark red crystals
- Analytical purity: 97.77%
- Purity test date: 4 May 2005
- Lot/batch No.: WC00504271
- Expiration date of the lot/batch: July 2007
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: at room temperature (20 °C ± 5 °C), protected from humidity and light. Storage under inert gas (nitrogen)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV, Horst, The Netherlands
- Age at study initiation: male: 13-14 weeks, female 8-9 weeks
- Weight at study initiation: 1460 - 2418 g
- Housing: Individually in stainless steel cages, equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks were provided for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 8/06) provided by Provimi Kliba AG, Kaiseraugst.
- Water (e.g. ad libitum): Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: yes, under laboratory conditions after health examinations. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-15 changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark (automatically controlled light cycle, with music played during the daytime)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per animal moistened with purified water
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL of water was used to moisten the substance - Duration of treatment / exposure:
- 4 hours
- Observation period:
- VIABILITY/MORTALITY
Daily from acclimatisation of the animals to the termination of the test
CLINICAL SIGNS
Daily from acclimatisation of the animals to the termination of the test
BODYWEIGHTS
At start of acclimatisation, on the day of application and at termination of observation
SKIN OBSREVATION
The skin reaction was assessed at approximately 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after exposure (removal of the dressing, gauze patch and test item) - Number of animals:
- 3 animals (1 male, 2 female)
- Details on study design:
- TEST SITE
- Area of exposure: left flank
- % coverage: not reported, 4 cm x 4 cm
- Type of wrap if used: surgical gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 4 hour treatment, the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site
- Time after start of exposure: 4 hours
SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004. If evident, corrosive or straining properties of the test item were described and recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.00, 0.00 and 0.33 respectively and the mean oedema score was 0.00 for all the animals. Very slight erythema forming was observed in all animals, one hour after removal of the dressing and persisted in one female animal until the 24 hour reading.
Neither alterations of the treated skin were observed, nor were corrosive effects evident on the skin. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. Slight red staining of the treated skin area produced by the test item was present in all animals from the 1 hour to the 7 day reading and persisted in one female animal until the 10-day reading. No abnormal findings were observed on the treated skin of animals 14 days after treatment, the end of the observation time. The body weights of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
Table 1: Bodyweights
Animal No. |
Sex |
First day of acclimatisation |
Day of treatment |
Last day of observation |
31 |
Male |
2130 |
2418 |
2841 |
32 |
Female |
1304 |
1407 |
1936 |
33 |
Female |
1249 |
1460 |
1864 |
Table 2: Skin irritation scores (individual values)
Animal number |
Sex |
Evaluation interval* |
Erythema |
Oedema |
31 32 33 |
M F F |
1 hour |
1 1 1 |
0 0 0 |
31 32 33 |
M F F |
24 hours |
0 0 1 |
0 0 0 |
31 32 33 |
M F F |
48 hours |
0 0 0 |
0 0 0 |
31 32 33 |
M F F |
72 hours |
0 0 0 |
0 0 0 |
31 32 33 |
M F F |
7 days |
0 0 0 |
0 0 0 |
31 32 33 |
M F F |
10 days |
0 0 0 |
0 0 0 |
31 32 33 |
M F F |
14 days |
0 0 0 |
0 0 0 |
* examinations were performed at the specified times after removal of the dressing.
Note: observations continued for 14 days due to staining present on the skin
Table 3: Skin irritation scores (Individual mean values after 24, 48 and 72 hours)
Animal number |
Sex |
Erythema |
N |
Oedema |
N |
31 32 33 |
M F F |
0.00 0.00 0.33 |
3 3 3 |
0.00 0.00 0.00 |
3 3 3 |
N = number of available data points
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the referred classification criteria (Commission Directive 2001/59/EC of August 2001), the test item is considered to be "not irritating" to rabbit skin.
- Executive summary:
The primary skin irritation potential of the test item was investigated under GLP according to OECD TG 404. The test item was applied by topical semi-occlusive application of 0.5 g substance moistened with 0.5 mL of water to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment under occlusion was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades separately. The mean erythema/eschar score of the three animals was 0.00, 0.00 and 0.33 respectively and the mean oedema score was 0.00 for all the animals.
The application of the test item to the skin resulted in very slight erythema in all animals 1 hour after removal of the dressing, persisting in one female animal until the 24 -hour reading. Red staining of the treated skin area produced by the test item was noted in all animals from the 1-hour reading to the 7-day reading and persisted in one female animal until the 10-day reading. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the skin.
Based on the referred classification criteria (Commission Directive 2001/59/EC of August 2001), the test item is considered to be "not irritating" to rabbit 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.
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