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EC number: 416-600-4 | CAS number: -
- 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
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Endpoint summary
Administrative data
Description of key information
HAT ISO was assessed for skin sensitization in two studies. In the key study, a guinea pig maximization test EU Method B.6 (Skin Sensitisation), no sensitization by skin contact was revealed. The second study was also a guinea pig maximization test. However, the disregarded study was considered not valid (reliability grade 3), as the test material was contaminated with solvent residues.
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:
- 1996-12-09 to 1997-01-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- EC 92/69
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 1997. By this time the LLNA was not established yet.
- Specific details on test material used for the study:
- Analytical purity: treated as 100 % pure
Lot/batch No.: V96/16 - Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland;
- Age at study initiation: approx. 6 weeks;
- Weight at study initiation: max. 500 g,
- Housing: groups of 5 in metal wire cages with wire-mesh floors;
- Diet: standard guinea pig diet ad libitum; Suppl.: Hope Farms, Woerden, The Netherlands;
- Water: tap-water, diluted with decalcified water, ad libitum;
- Acclimation period: at least 5 days;
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C;
- Humidity: 50 % R.H.
- Air changes: approx. 15 air changes per hour;
- Photoperiod: 12 hours artificial fluorescent light/12 hours dark;
- Route:
- intradermal and epicutaneous
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- Induction: 0.2 % test substance concentration
- Route:
- epicutaneous, occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Concentration / amount:
- Challenge: 50 % test substance concentration;
- No. of animals per dose:
- Experimental group: 10 females,
Control group: 5 females; - Details on study design:
- Test substance concentrations (in 1 % aqueous carboxymethyl cellulose) selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 0.2 % concentration and epidermally exposed to a 50 % concentration. Five control animals were similarly treated, but with vehicle only. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10 % SDS. Two weeks after the epidermal application all animals were challenged with a 50 % test substance concentration and the vehicle.
- Positive control substance(s):
- not specified
- Positive control results:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Key result
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- HAT S2 was tested for skin sensitization properties in the albino guinea pig maximization test. No skin reactions were evident after the challenge exposure in the experimental and control animals. This result indicates a sensitisation rate of 0 %. No classification and labelling for skin sensitization is necessary according to Regulation 1272/2008/EC (CLP).
- Executive summary:
HAT S2 was tested for skin sensitization properties in the albino guinea pig maximization test.
No skin reactions were evident after the challenge exposure in the experimental and control animals. No evidence was obtained that HAT S2 had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitisation rate of 0 %. Therefore, HAT S2 can be regarded as not sensitizing
Reference
Based on the results of a preliminary study, the test substance concentrations selected for the main study were a 0.2 % concentration for the intradermal induction and a 50 % concentration for the epidermal induction exposure.
Since no signs of irritation were observed at the concentrations selected for the epidermal induction, all animals were treated with 10 % SDS (Sodium Dodecyl Sulfate) approximately 24 hours before the epidermal induction. A 50 % test substance concentration was selected for the challenge phase.
Induction phase:
The skin effects caused by the intradermal injections and epidermal exposure during the induction phase are given in the table. The reactions noted in two experimental animals after the epidermal induction exposure were considered to be enhanced by the SDS treatment.
Induction
Animal Number |
Intradermal Injection (DAY 3) |
Epidermal Exposure (DAY 10) 50%# |
|||
A |
B |
C |
|||
Control |
Erythema |
Oedema |
|||
72 |
E1 |
NA |
E1 |
0 |
0 |
73 |
E1 |
NA |
E1 |
0 |
0 |
74 |
E1 |
NA |
E1 |
0 |
0 |
75 |
E1 |
NA |
E1 |
0 |
0 |
76 |
E1 |
NA |
E1 |
0 |
0 |
Experimental |
|
|
|||
77 |
E1 |
NA |
E1 |
0 |
0 |
78 |
E1 |
NA |
E1 |
0 |
0 |
79 |
E1 |
NA |
E1 |
0 |
0 |
80 |
E2 |
NA |
E2 |
0a |
0 |
81 |
E1 |
NA |
E1 |
0 |
0 |
82 |
E2 |
NA |
E1 |
0a |
0 |
83 |
N3 |
NA |
E1 |
0 |
0 |
84 |
E1 |
NA |
E1 |
0 |
0 |
85 |
E1 |
NA |
E1 |
0 |
0 |
86 |
E1 |
NA |
E1 |
0 |
0 |
A. 1 : 1 mixture of FCA and water for injection.
B. A 0..2% test substance concentration (Experimental); vehicle (Control).
C. 1 : 1 mixture of FCA and a 0.4% concentration (Experimental) or vehicle (Control).
#. Test Substance concentration.
a. Small scabs
Skin effects intradermal injections:
NA No abnormalities
E( . ) Erythema (grade)
N ( . ) Signs of necrosis (mm in diameter)
Challenge phase:
No skin reactions were evident after the challenge exposure in the experimental and control animals (see table).
Challenge
CHALLENGE |
|||||
Animal No. |
DAY 24 |
DAY 25 |
COMMENTS |
||
50%# |
Vehicle |
50% |
Vehicle |
||
Control |
|||||
72 |
0 |
0 |
0 |
0 |
0 |
73 |
0 |
0 |
0 |
0 |
0 |
74 |
0 |
0 |
0 |
0 |
0 |
75 |
0 |
0 |
0 |
0 |
0 |
76 |
0 |
0 |
0 |
0 |
0 |
Experimental |
|
|
|||
77 |
0 |
0 |
0 |
0 |
not sensitised |
78 |
0 |
0 |
0 |
0 |
not sensitised |
79 |
0 |
0 |
0 |
0 |
not sensitised |
80 |
0 |
0 |
0 |
0 |
not sensitised |
81 |
0 |
0 |
0 |
0 |
not sensitised |
82 |
0 |
0 |
0 |
0 |
not sensitised |
83 |
0 |
0 |
0 |
0 |
not sensitised |
84 |
0 |
0 |
0 |
0 |
not sensitised |
85 |
0 |
0 |
0 |
0 |
not sensitised |
86 |
0 |
0 |
0 |
0 |
not sensitised |
# . Test substance concentration.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Key study:
HAT S2 was tested for skin sensitization properties in the guinea pig maximization test according to EU Method B.6. No skin reactions were evident after the challenge exposure in the experimental and control animals. No responses were observed in the experimental animals in the challenge phase, thus no evidence was obtained indicating HAT S2 to cause skin hypersensitivity in the guinea pig. This result indicated a sensitization rate of 0 %. Therefore, HAT S2 was regarded as not sensitizing.
Disregarded study:
Mastic base PATE HAT was tested for cutaneous delayed hypersensitivity in the albino Hartley guinea pig. This test was performed with a method equivalent or similar to EU-Method B.6. From the results obtained under the experimental conditions employed, the test article provoked a reaction of cutaneous sensitization in 63 % of the animals examined. Its sensitizing potential to the skin of the guinea-pig is moderate (grade III). Further investigation showed that the test sample was contaminated with solvent residues, which caused the sensitization reactions. Therefore, the results of this study were not used to derive the classification and labelling. For more details on classification and labelling see the INRS/BERPC Official Notice (2006) attached in section 13.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. Based on
available data on skin sensitisin properties, the test item does not
require classification according to Regulation (EC) No 1272/2008 (CLP),
as amended for the tenth time in Regulation (EU) No 2017/776.
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.
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