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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 403-920-4 | CAS number: 107551-67-7 G 19-675 ZP
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 2, 1988 to March 6, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented, according to accepted guideline, with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
- EC Number:
- 403-920-4
- EC Name:
- 3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
- Cas Number:
- 107551-67-7
- Molecular formula:
- C13H18O3
- IUPAC Name:
- 3-(3-tert-butyl-4-hydroxyphenyl)propanoic acid
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- other: Chinese
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation:
a) Tolerability test: 27-35 g (males and females).
b) Mutagenicity test: 22-35 g (males); 21-34 g (females).
- Assigned to test groups randomly: Yes.
- Housing: Individually housed.
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: At least 3 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23°C.
- Humidity (%): 43-54%.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: CMC (carboxymethyl cellulose)
- Concentration of test material in vehicle: 0.5%
- Amount of vehicle (if gavage or dermal): 20 mL/kg.
- Manufacturer of Carboxymethyl cellulose (CMC): Hercules Comp.,USA. - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: 4000 mg/kg in 20 mL/kg CMC 0.5%.
DIET PREPARATION: Standard diet: NAFAG No. 924. - Duration of treatment / exposure:
- Single exposure.
- Frequency of treatment:
- Single exposure.
- Post exposure period:
- 16, 24, 48 hours after treatment application.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
200, 1000, 5000 mg/kg
Basis:
actual ingested
Tolerability test 1
- Remarks:
- Doses / Concentrations:
4000 mg/kg
Basis:
actual ingested
Tolerability test 2
- Remarks:
- Doses / Concentrations:
4000 mg/kg
Basis:
actual ingested
Mutagenicity test
- No. of animals per sex per dose:
- - In the tolerability test: 2/sex/group.
- In the mutagenicity test: 24/sex/group, except 8/sex/group in positive control group. - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide.
- Route of administration: Oral (not specified).
- Doses / concentrations: 64 mg/kg cyclophosphamide in 20 mL CMC 0.5%.
Examinations
- Tissues and cell types examined:
- Bone marrow (erythrocytes) is harvested from the shafts of both femurs.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
A preliminary test was performed to determine the suitable dosage of the test substance to be applied in the mutagenicity assay.
Three groups of four Chinese hamsters (two females and two males) are treated with three different doses, one receiving the maximum dose of 5000 mg/kg, or the highest applicable dose, and the other two doses of 1/5 (1000 mg/kg) and 1/25 (200 mg/kg) of that amount respectively. The animals are treated with a single dose. The observation period corresponds to the interval between administration and sacrifice of the animals in the mutagenicity test, plus one day. If all animals in all dose groups die in the first step, a second test is performed in which the highest dose given is 3/4 of the lowest used in the preceding test. If some of the animals in one of the dose groups die, the test is continued with a high dose corresponding to a predetermined fraction of that dose. Depending on the outcome the highest dose causing no death is used as the highest in the mutagenicity test, or if necessary the test is repeated with lower doses.
TREATMENT AND SAMPLING TIMES (in addition to information in specific fields):
The preparation was administered orally to animals. Treatment consisted of a single application. 16, 24 and 48 hours after application 8 female and 8 male animals per sampling time were sacrificed by dislocation of the cervical vertebrae.
DETAILS OF SLIDE PREPARATION:
Bone marrow is harvested from the shafts of both femurs with fetal calf serum. After centrifugation small drops of the sediment mixture are transferred on the end of a slide, spread out with the aid of a polished cover glass and the preparations are air-dried. Within 24 hours, the slides are stained in undiluted May-Grünwald solution for 3 minutes then in May-Grünwald solution/water 1/1 for 2 minutes. After being rinsed in distilled water, the slides are left immersed in diluted Giemsa solution (16.6%), for 10 minutes. After rinsing with distilled water and air-drying, the slides are cleared in Xylene and mounted.
METHOD OF ANALYSIS:
Prior to analysis the slides are coded. Thereafter the quality of staining is evaluated. The slides of five animals from each sex showing the best differentiation between mature and polychromatic erythrocytes are selected for later scoring. The slides of five female and five male animals each of the negative control group and of the dosage group sacrificed at 16, 24 and 48 hours post treatment are examined. From the animals of the positive control group which are sacrificed 24 hours after application, the slides of five female and five male animals are scored. 1000 polychromatic erythrocytes per animal each are scored for the incidence of micronuclei. To determine the mitotic activity of the red compartment, the ratio of polychromatic to normochromatic erythrocytes is calculated for each animal by counting a total of 1000 erythrocytes. A low proportion of polychromatic erythrocytes is indicative for a mitosis inhibiting activity of the test substance. - Evaluation criteria:
- A test substance is considered to be active in this test system if a statistically significant increase in the number of polychromatic erythrocytes with micronuclei in comparison with the negative control occurs at any sampling time.
Assay acceptance criteria:
- The quality of the slides must allow a clear differentiation between polychromatic and normochromatic erythrocytes.
- The result obtained with the positive control has to fulfil the criteria given for a positive response. - Statistics:
- The significance of difference is assessed by Chi square-test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Additional information on results:
RESULTS OF RANGE-FINDING STUDY (Tolerability test)
- Dose range:
a) Test 1: 200, 1000, 5000 mg/kg
b) Test 2: 4000 mg/kg
- Clinical signs of toxicity in test animals: In Test 1 of the tolerability test the maximum dose (5000 mg/kg) caused the death of one animal. In Test 2 of the tolerability test the dose of 4000 mg/kg caused no death in a group of four animals.
- Rationale for exposure: Based on tolerability test.
RESULTS OF DEFINATIVE STUDY
- Ratio of PCE/NCE (for Micronucleus assay): Refer to Table 1.
- Appropriateness of dose levels and route: One female animal of the 24 hours dosage group died during the treatment period.
- Statistical evaluation: There was no significant increase in the number of micronucleated polychromatic erythrocytes in the animals treated with the dose of 4000 mg/kg as compared with the negative control animals at all three sampling times.
Any other information on results incl. tables
Table 1. Micronucleus Test on Chinese Hamster Bone Marrow Cells*
Sacrifice |
Treatment |
Sex |
PCE |
NCE |
Ratio of PCE/NCE |
Number of PCE with micronuclei |
% of PCE with micronuclei |
16 h |
Vehicle Control |
F |
559 |
441 |
1.3 |
0.6 |
0.06 |
M |
564 |
436 |
1.3 |
0.6 |
0.06 |
||
test item |
F |
515 |
485 |
1.1 |
1 |
0.1 |
|
M |
507 |
493 |
1 |
0.2 |
0.02 |
||
24 h |
Vehicle Control |
F |
526 |
474 |
1.1 |
0.2 |
0.02 |
M |
523 |
477 |
1.1 |
0.6 |
0.06 |
||
test item |
F |
505 |
495 |
1 |
0.2 |
0.02 |
|
M |
501 |
499 |
1 |
0.8 |
0.08 |
||
48 h |
Vehicle Control |
F |
529 |
471 |
1.1 |
0.4 |
0.04 |
M |
501 |
499 |
1 |
0.8 |
0.08 |
||
test item |
F |
491 |
509 |
1 |
0 |
0 |
|
M |
527 |
473 |
1.1 |
0.2 |
0.02 |
||
24 h |
Vehicle Control |
F |
526 |
474 |
1.1 |
0.2 |
0.02 |
M |
523 |
477 |
1.1 |
0.6 |
0.06 |
||
Positive control** |
F |
455 |
545 |
0.8 |
22 |
2.2 |
|
M |
487 |
513 |
0.9 |
22.6 |
2.26 |
% = percentage; F = females; h = hours; M = males; NCE = normochromatic erythrocytes; PCE = polychromatic erythrocytes.
* test item administered at 4,000 mg/kg.
** positive control = cyclophosphamide.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
It is concluded that under the conditions of this experiment, no evidence of mutagenic effects was obtained in Chinese hamsters treated withthe test substance.
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.