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EC number: 285-077-0 | CAS number: 85029-52-3
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 05 October 2012 to 31 October 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the OECD internationally recognised guideline and according to GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- removal of the furtake place 27h before the test instead 24h +/- 2h
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- removal of the furtake place 27h before the test instead 24h +/- 2h
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde
- EC Number:
- 285-077-0
- EC Name:
- Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde
- Cas Number:
- 85029-52-3
- Molecular formula:
- Not necessary (UVCB substance)
- IUPAC Name:
- (3R,4S)-6-({2,3-dihydroxy-5-[(3R,4S)-3,4,7-trihydroxy-3,4-dihydro-2H-1-benzopyran-2-yl]phenyl}methyl)-2-(3,4-dihydroxyphenyl)-3,4-dihydro-2H-1-benzopyran-3,4,7-triol; (3R,4S)-6-({2,3-dihydroxy-5-[(3R,4S)-3,4,7-trihydroxy-3,4-dihydro-2H-1-benzopyran-2-yl]phenyl}methyl)-2-(3-{[(3R,4S)-2-(3,4-dihydroxyphenyl)-3,4,7-trihydroxy-3,4-dihydro-2H-1-benzopyran-6-yl]methyl}-4,5-dihydroxyphenyl)-3,4-dihydro-2H-1-benzopyran-3,4,7-triol
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Acacia mearnsi, ext., reaction products with amonium chloride and formaldehyde
- Substance type: UVCB
- Physical state: liquid
- Density: 1.1-1.2
- Analytical purity: 100%
- Storage condition of test material: room temperature, protected from light
- Stabilty in container and water: stable
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Strain: Wistar rats Crl: WI(Han) (full barrier)
- Age at study initiation:males, 8-10weeks and female, 11-12 weeks
- Weight at study initiation: males, 245-254 g and females, 216-240 g
- Housing: the animal were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 190612)
- Diet (e.g. ad libitum): free access to Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): free access to tap water, sulphur acidfied to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10x/hour
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Type of coverage:
- other: The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal
- % coverage: approximately 10%
- Type of wrap if used: the dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test item was removed using aqua ad injectionem (Allem Pharma, lot no. 120203).
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the test item was applied at a single dose of 2000 mg/kg body weight to each animal. - Duration of exposure:
- - 24 hours
- Doses:
- - The test item was applied at a single dose of 2000 mg/kg body weight to each animal.
- No. of animals per sex per dose:
- - 5 males and 5 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: The animals were weighed on day 1 (prior to the application) and on days 8 and 15.
- Frequency of observations: A careful clinical examination was made several times on the day of dosing (once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: cageside observations included changes in the skin and fur, eyes and mucous menbranes. Also respiratory, circulatory, autonomic amd central nervous systems and somatomotor activity and behaviour pattern were examinated. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, sleep and coma.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - No mortality
- Clinical signs:
- other: - No signs of toxicity but signs of dermal irritation: no erythema or oedema was observed. Eschar was observed in 1 of 5 male animals. Scratches were observed in 4 or 5 male and all female animals (see table 1 and table 2). All signs of irritation were re
- Gross pathology:
- - No specific findings for all animals.
Any other information on results incl. tables
Table 1: Skin Irritation, individual data for males
Day after startof application | Animal No. 21 | Animal No. 22 | Animal No. 23 | Animal No. 24 | Animal No. 25 | |||||
E/O | Comments | E/0 | Comments | E/O | Comments | E/O | Comments | E/O | Comments | |
day 2 | 0/0 | nsf | 0/0 | nsf | 0/0 | nsf | 0/0 | nsf | 0/0 | nsf |
day 3 | 0/0 | s* | 0/0 | * | 0/0 | s* | 0/0 | s* | 0/0 | s* |
day 4 | 0/0 | s* | 0/0 | * | 0/0 | s* | 0/0 | s* | 0/0 | s* |
day 5 | 0/0 | s* | 0/0 | * | 0/0 | s* | 0/0 | s* | 0/0 | s* |
day 6 | 0/0 | s* | 0/0 | * | 0/0 | s* | 0/0 | s* | 0/0 | s* |
day 7 | 0/0 | s* | 0/0 | * | 0/0 | s* | 0/0 | s* | 0/0 | s* |
day 8 | 0/0 | s* | 0/0 | * | 0/0 | * | 0/0 | s* | 0/0 | * |
day 9 | 0/0 | s* | 0/0 | * | 0/0 | * | 0/0 | s* | 0/0 | * |
day 10 | 0/0 | s* | 0/0 | * | 0/0 | * | 0/0 | s* | 0/0 | * |
day 11 | 0/0 | s* | 0/0 | * | 0/0 | * | 0/0 | es* | 0/0 | * |
day 12 | 0/0 | s* | 0/0 | * | 0/0 | * | 0/0 | es* | 0/0 | * |
day 13 | 0/0 | * | 0/0 | * | 0/0 | * | 0/0 | * | 0/0 | * |
day 14 | 0/0 | * | 0/0 | * | 0/0 | * | 0/0 | * | 0/0 | * |
day 15 | 0/0 | * | 0/0 | * | 0/0 | * | 0/0 | * | 0/0 | * |
E = erythema; O = oedema; 0,1,2,3,4 = scoring system laid down in OECD guideline 404; es = eschar; s = scratches; * = residual test item (yellow); nsf = no specific findings
Table 2: Skin Irritation, individual data for females
Day after startof application | Animal No. 26 | Animal No. 27 | Animal No. 28 | Animal No. 29 | Animal No. 30 | |||||
E/O | Comments | E/0 | Comments | E/O | Comments | E/O | Comments | E/O | Comments | |
day 2 | 0/0 | nsf | 0/0 | nsf | 0/0 | nsf | 0/0 | nsf | 0/0 | nsf |
day 3 | 0/0 | s* | 0/0 | s* | 0/0 | s* | 0/0 | s* | 0/0 | s* |
day 4 | 0/0 | s* | 0/0 | s* | 0/0 | s* | 0/0 | s* | 0/0 | s* |
day 5 | 0/0 | s* | 0/0 | s* | 0/0 | s* | 0/0 | s* | 0/0 | s* |
day 6 | 0/0 | s* | 0/0 | s* | 0/0 | s* | 0/0 | s* | 0/0 | s* |
day 7 | 0/0 | s* | 0/0 | s* | 0/0 | s* | 0/0 | s* | 0/0 | s* |
day 8 | 0/0 | s* | 0/0 | * | 0/0 | s* | 0/0 | s* | 0/0 | * |
day 9 | 0/0 | s* | 0/0 | * | 0/0 | s* | 0/0 | s* | 0/0 | * |
day 10 | 0/0 | s* | 0/0 | * | 0/0 | * | 0/0 | s* | 0/0 | * |
day 11 | 0/0 | s* | 0/0 | * | 0/0 | * | 0/0 | s* | 0/0 | * |
day 12 | 0/0 | s* | 0/0 | * | 0/0 | * | 0/0 | s* | 0/0 | * |
day 13 | 0/0 | s* | 0/0 | * | 0/0 | * | 0/0 | * | 0/0 | * |
day 14 | 0/0 | s* | 0/0 | * | 0/0 | * | 0/0 | * | 0/0 | * |
day 15 | 0/0 | * | 0/0 | * | 0/0 | * | 0/0 | * | 0/0 | * |
E = erythema; O = oedema; 0,1,2,3,4 = scoring system laid down in OECD guideline 404; es = eschar; s = scratches; * = residual test item (yellow); nsf = no specific findings
Table 3: Absolute body weights in g and body weight gain in %
Dose: 2000 mg/kg body weight | ||||
Animal No. / Sex | Day 1 (g) | Day 8 (g) | Day 15 (g) | Day 1 -15 (%) |
21 / male | 245 | 266 | 292 | 19 |
22 / male | 254 | 272 | 300 | 18 |
23 / male | 254 | 288 | 321 | 26 |
24 / male | 248 | 277 | 314 | 27 |
25 / male | 251 | 285 | 316 | 26 |
26 / female | 216 | 216 | 221 | 2 |
27 / female | 227 | 218 | 226 | 0 |
28 / female | 235 | 220 | 232 | -1 |
29 / female | 227 | 223 | 232 | 2 |
30 / female | 240 | 233 | 239 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to Annex I of Regulation (EC) 1272/2008 the test item Acacia mearnsi extract is unclassified for acute dermal toxicity in the test conditions.
- Executive summary:
Under the conditions of the present study, single dermal application of the test item Acacia mearnsi extract to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity but signs of dermal irritation. However, all signs of irritation were reversible within the observation period.
The dermal LD50 was determinated to be > 2000 mg Acacia mearnsi extract/kg body weight.
According to Annex I of Regulation (EC) 1272/2008 the test item Acacia mearnsi extract is unclassified for acute dermal toxicity and skin irritation in the test conditions.
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