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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 425-400-6 | CAS number: 179986-09-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD, GLP, QAU)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted July, 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 425-400-6
- EC Name:
- -
- Cas Number:
- 179986-09-5
- Molecular formula:
- UVCB substance
- IUPAC Name:
- methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate; propane-1,2,3-triol; tetradecanoic acid
- Details on test material:
- - Physical state: colourless liquid
- Analytical purity: 95%
- Storage condition of test material: at room temperature away from direct sunlight
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 243 - 314 g
- Housing: individually in Makrolon type-3 cages with standard softwood bedding
- Diet (ad libitum): pelleted standard Nafag Ecosan 845 25W4
- Water (ad libitum): tap water
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 5 % ( intradermal induction), 100 % (epicutaneous induction and challenge)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 5 % ( intradermal induction), 100 % (epicutaneous induction and challenge)
- No. of animals per dose:
- 20 (test group), 10 (control group)
- Details on study design:
- RANGE FINDING TESTS: The objective of this investigation was to identify a maximally tolerated concentration of the test article suitable for the induction phase of the main study (2 animals). In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application (4 animals).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal exposure (day 1) and 1 epicutaneous exposure (day 8)
- Exposure period: 3 pairs of intradermal injections on day 1 and an epicutaneous exposure on day 8 for 48 hours
- Test groups: 1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test article, diluted to 5% with polyethylene glycol 400.
3) The test article diluted to 5% by emulsion in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Control group: 1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) Polyethylene glycol 400
3) 1:1 (w/w) mixture of polyethylene glycol 400 in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline
- Epicutaneous exposure: approximately 0.3 g of the unchanged test substance was applied under an occlusive dressing, duration of exposure 48 hours; Readings after 48 hours after the beginning of application.
- Site: area of dorsal skin from the scapular region
- Frequency of applications: intradermal injections and 1 epicutaneous exposure (see above)
- Duration: Day 1 (intradermal injection) – Day 8 (epicutaneous exposure)
- Concentrations: 5 % of the test substance for intradermal induction; 100 % of the test substance for epicutaneous application and in the challenge
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22 days after intradermal injection
- Exposure period: 24 hours
- Test groups: 100% (saturated filter paper) of the test substance on the left flank under an occlusive dressing.
- Control group: 100% (saturated filter paper) of the test substance on the left flank under an occlusive dressing.
- Site: left flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24, 48 hours after removal of the dressing - Challenge controls:
- none
- Positive control substance(s):
- yes
- Remarks:
- The sensitivity and reliability of the experimental technique used was assessed by use of substances which are known to have skin sensitization properties in the guinea pig strain. The positive controls were performed with 2-MERCAPTOBENZOTHIAZOLE.
Results and discussion
- Positive control results:
- In the studies with the positive controls 90% (at the 24-hour reading) and 100% (at the 48-hour reading) of the tested animals showed positive skin reaction after treatment with a non-irritant test substance concentration of 50% in mineral oil. No skin reactions were observed in the control group. A response of at least 30% positive animals is considered positive "R43": may cause sensitization by skin contact according to the "Commission Directive 93/21/EEC, April 27, 1993 adapting to technical progress for the 18th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances". Therefore, the test article 2-MERCAPTOBENZOTHIAZOLE applied at a concentration of 50% in mineral oil is considered to be a sensitizer. According to the rating of allergenicity by Magnusson and Kligman the test article is an extreme sensitizer.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- 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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- 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: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0.
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.