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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 470-870-8 | CAS number: 690271-93-3
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 August 2004 to 11 September 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP in accordance with an internationally recognised test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A Guinea Pig Maximisation study result which pre-dates the OECD guideline for the LLNA is available and the study is considered to be of sufficient reliability to satisfy the data requirement. On this basis it is considered that a supplementary LLNA would not be appropriate.
- Species:
- guinea pig
- Strain:
- other: Hartley albino
- Sex:
- male
- Route:
- other: First induction phase - intradermal. Second induction phase - topical
- Vehicle:
- water
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal induction 1% w/w mixture in distilled water
b) topical induction 70% w/w mixture in distilled water
Concentration of test material and vehicle used for each challenge:
70% w/w mixture of the test substance in distilled water
23% w/w mixture of the test substance in distilled water - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal induction 1% w/w mixture in distilled water
b) topical induction 70% w/w mixture in distilled water
Concentration of test material and vehicle used for each challenge:
70% w/w mixture of the test substance in distilled water
23% w/w mixture of the test substance in distilled water - No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- RANGE FINDING TESTS:
Prior to the induction phase, a group of four animals was used to determine the concentration of the test substance which produced faint to moderate irritation via intradermal injection. Each guinea pig received six intradermal injections (0.1 m1 each); three concentrations (1, 3, and 5%) of the test substance in distilled water and the same three concentrations in an emulsion of Complete Freund's Adjuvant.
Prior to the topical induction, a group of four animals was used to determine the irritation potential of the test substance to be used during the topical induction. The test substance was mixed with distilled water to yield w/w concentrations of 70%1 and 53% (75% of the dry paste concentration).
A group of four animals was used to determine the highest non-irritating concentration. The test substance was mixed with distilled water to yield w/w concentrations of 70%, 53%, 35% and 18%.
Based on these findings, the concentrations which produced very faint to faint irritation (0.5-1) for the intradermal induction were the 3% and 5% w/w mixtures in distilled water. However, due to the difficulty of injection at these concentrations a 1% w/w mixture was used. That which produced very
faint to faint irritation (0.5-1) selected for the topical induction was a 70% w/w mixture in distilled water with a pretreatment of sodium lauryl sulfate (SLS). The HNIC selected for the challenge phase was a 70% w/w mixture in distilled water.
MAIN STUDY
INDUCTION EXPOSURE (intradermal phase)
- No. of exposures: 6
- Exposure period: 48 hours
- Concentrations: i) 50% v/v mixture Complete Freund's Adjuvant in distilled water
ii) 1% w/w mixture of test substance in distilled water
iii)1% w/w mixture of test substance in 50% Complete Freund's Adjuvant in distilled water
INDUCTION EXPOSURE (topical phase)
- No. of exposures: 1
- Exposure period: 48 hours
- Concentrations: 0.5 g of a 70% w/w mixture of the test substance in distilled water
B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Day(s) of challenge: challenge phase started on Day 21
- Concentrations: i) 0.5 g of a 70% w/w mixture of the test substance (HNIC) in distilled water
ii) 0.5 ml of a 23% w/w mixture (33% dilution of the HNIC)
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- 0.5 ml of distilled water
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 70 %
- 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: 70 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 23 %
- 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: 23 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 70 %
- 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: 70 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 23 %
- 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: 23 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 %
- 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: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a Guinea pig maximisation test according to OECD 406 and OPPTS 270.2600 test guidelines, a group of twenty experimental animals (guinea pigs) were treated with test substance concentrations of 1% intradermally, 70% epidermally, and 70% at challenge. 50% Complete Freund's Adjuvant in distilled water was used as vehicle. None of the animals showed a positive response at both 24 and 48 hours after challenge, indicating no sensitisation. Therefore, Terracess TF was considered not to be a skin sensitiser.
Migrated from Short description of key information:
Not sensitising (OECD 406/OPPT 270.2600 Guinea Pig Maximisation Test
Justification for selection of skin sensitisation endpoint:
One valid and available study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the Guinea pig maximisation test, Terracess TF does not have to be classified for skin sensitisation according to CLP Regulation EC (No.) 1272/2008.
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.