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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Feb. 9, 1988 to Apr. 12, 1988
- 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:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland.
- Age at study initiation: Approximately 10 weeks old.
- Weight at study initiation: 310 to 445 g.
- Housing: Housed individually in Macrolon cages (Type 3).
- Diet (e.g. ad libitum): ad libitum.
- Water (e.g. ad libitum): ad libitum.
- Acclimation period: 8 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C.
- Humidity (%): 30 to 70%.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: sesame oil or vaseline
- Concentration / amount:
- Induction:
Intradermal: 1% in sesame oil.
Epidermal: Approximately 0.4 g paste of 30% in vaseline.
Challenge: Approximately 0.2 g paste of 10% in vaseline.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil or vaseline
- Concentration / amount:
- Induction:
Intradermal: 1% in sesame oil.
Epidermal: Approximately 0.4 g paste of 30% in vaseline.
Challenge: Approximately 0.2 g paste of 10% in vaseline.
- No. of animals per dose:
- 10/sex/group .
- Details on study design:
- RANGE FINDING TESTS: Separate animals were treated with the test substance for the evaluation of the primary irritation threshold concentration.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2.
- Exposure period: First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later for 48 hours.
- Control group: Treated with adjuvant and the vehicle during the induction period.
- Site: The neck region.
- Concentrations:
First induction (Intradermal): 1% in sesame oil and adjuvant mixture.
Second induction (Epidermal): Approximately 0.4 g paste of 30 % in vaseline.
B. CHALLENGE EXPOSURE
- No. of exposures: 1.
- Day(s) of challenge: Two weeks after the epidermal induction application.
- Exposure period: 24 hours.
- Test groups: substance in vaseline.
- Control group: Vehicle and test compound.
- Site: Flank.
- Concentrations: Approximately 0.2 g paste of 10 % in vaseline.
- Evaluation (hr after challenge): Twenty four hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale (Appendix 1). A second evaluation was made 48 hours after removing the dressings.
The sensitizing potential was classified according to the grading of Magnusson and Kligman (Refer to Table 1).
The body weight was recorded at start and end of the test. - Challenge controls:
- A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
- Positive control substance(s):
- yes
- Remarks:
- Paraphenylene-diamine or Potassium-dichromate
Results and discussion
- Positive control results:
- The sensitivity of the strain is checked every six months with Paraphenylene-diamine or Potassium-dichromate.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 g paste of 10% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 g paste of 10% in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.2 g paste of 10% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.2 g paste of 10% in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 g paste of 10% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 g paste of 10% in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.2 g paste of 10% in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.2 g paste of 10% in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Table 2. Challenge reactions after epicutaneous administration
Animal |
Erythema score |
Edema score |
||
24 h* |
48 h** |
24 h |
48 h |
|
Test group Male |
0 |
0 |
0 |
0 |
Test group Female |
0 |
0 |
0 |
0 |
Control group Male |
0 |
0 |
0 |
0 |
Control group Female |
0 |
0 |
0 |
0 |
* DRAIZE Score 24 hours after removal of the dressing.
** DRAIZE Score 48 hours after removal of the dressing.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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.