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EC number: 916-914-6 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 6, 1981 to April 15, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of Octyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate and 2-Ethylhexyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate
- EC Number:
- 916-914-6
- Molecular formula:
- C27H36ClN3O3
- IUPAC Name:
- Reaction mass of Octyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate and 2-Ethylhexyl-3-[3-tert-butyl-4-hydroxy-5-(5-chloro-2H-benzotriazole-2-yl)phenyl]propionate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Weight at study initiation: 2 to 3 kg
- Housing: individually in metal cages
- Water: ad libitum
- Acclimation period: a minimum 4 days
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10%
- Photoperiod: 12hrs light cycle day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.5 mL of the test material
- Duration of treatment / exposure:
- 24 hour
- Observation period:
- 24 hours, 48 hours, 72 hours, 4 days and 7 days after the patches removal
- Number of animals:
- For male: three
For female: three - Details on study design:
- - Area of exposure: the prepared abraded and intact skin
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 2
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24/72 h
- Score:
- 1.9
- Max. score:
- 3.3
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.8
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
Any other information on results incl. tables
Table 1. Calculation of the primary skin irritation index
Time after exposure hours |
Mean reaction score |
|||
Erythema |
Edema |
|||
Intact skin |
Abraded skin |
Intact skin |
Abraded skin |
|
24 |
1.5 |
1.8 |
0.3 |
0.5 |
72 |
1.5 |
1.5 |
0.3 |
0.3 |
Primary Irritation Index (PII)* = 1.9 |
* The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. (FHSLA § 191.11)
Assessment of irritation
0
0.1-1.0 = minimal
1.1-2.0 = slight
2.1-4.0 = moderate
4.1-6.0 = marked
6.1-8.0 = extreme
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to U.S. EPA § 163.81-5, Federal Register, Vol. 43, No. 163 (1978) and assessment of irritation, the PII for TK 12871 was 1.9 and TK 12871 was found to cause a slight irritation when applied to intact and abraded rabbit skin. Therefore, TK 12871 was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the CIBA-GEIGY Study Plan for 810283 and U.S. EPA § 163.81-5, Federal Register, Vol. 43, No. 163 (1978). The sites were grades for erythema and edema at 24 hours, 48 hours, 72 hours, 4 days and 7 days after the patches removal. The Primary Irritation Index for TK 12871 was calculated to be 1.9. On the basis of the test results given above and according toassessment of irritation, TK 12871 was found to cause a slight irritation when applied to intact and abraded rabbit skin.
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