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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
Endpoint summary
Administrative data
Description of key information
Skin irritation
The Primary Irritation Index (PII) of TK 12871 was 1.9 and TK 12871 was found to cause a slight irritation when applied to intact and abraded rabbit skin (U.S. EPA § 163.81-5, Federal Register, Vol. 43, No. 163).
Eye irritation
TK 12871 was found to cause a minimal irritation when applied to the rabbit eye mucosa (U.S. EPA § 163.81-4, Federal Register, Vol. 43, No. 163).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- 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 - 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
- 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
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From April 6, 1981 to April 14, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: The United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Water: ad libitum
- Acclimation period: minimum of 4 days
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10%
- Photoperiod: 12-hrs light cycle day - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.1 mL
- Observation period (in vivo):
- day 1, 2, 3, 4 and 7
- Number of animals or in vitro replicates:
- For male: three
For female: three - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #103, 104, 105, 106 107, 108
- Remarks:
- Not rinsed: #103, 104 and 105; rinsed: #106, 107 and 108
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #103, 104, 105, 106 107, 108
- Remarks:
- Not rinsed: #103, 104 and 105; rinsed: #106, 107 and 108
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #105
- Remarks:
- Not rinsed
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #103, 104, 106, 107, 108
- Remarks:
- Not rinsed: #103 and 104; rinsed: #106, 107 and 108
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #103, 104, 105, 107, 108
- Remarks:
- Not rinsed: #103, 104 and 105; rinsed: #107 and 108
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #106
- Remarks:
- Rinsed
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Remarks on result:
- probability of weak irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to U.S. EPA § 163.81-4, Federal Register, Vol. 43, No. 163 (1978), TK 12871 was found to cause a minimal irritation when applied to the rabbit eye mucosa. 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 810282 and U.S. EPA § 163.81-4, Federal Register, Vol. 43, No. 163 (1978). The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. TK 12871 was found to cause a minimal irritation (primary irritation index 0.7) when applied to the rabbit eye mucosa. When the application site was rinsed, the irritation was found to be minimal (primary irritation index 0.9).
Reference
Table 1. Calculation of the primary eye irritation index
Time after exposure days |
Mean reaction score |
|||||
Unrinsed eyes (A) |
Rinsed eyes (B) |
|||||
cornea |
iris |
conjunctive |
cornea |
iris |
conjunctive |
|
1 |
0 |
0 |
2.7 |
0 |
0 |
3.3 |
2 |
0 |
0 |
0 |
0 |
0 |
1.3 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
0 |
7 |
0 |
0 |
0.7 |
0 |
0 |
0 |
Subtotal |
0 |
0 |
3.4 |
0 |
0 |
4.6 |
Ttotal |
3.4 |
4.6 |
||||
Primary irritation index* |
0.7 |
0.9 |
*The mean reaction scores for cornea, iris and conjunctiva observed after 1, 2, 3, 4 and 7 days were summed up and the sum divided by 5.
Index 0 = none
0.1 - 10.9 = minimal
11.0 - 25.9 = slight
26.0 - 55.9 = moderate
56.0 - 84.0 = marked
above 84.0 = extreme
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
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 to assessment of irritation, TK 12871 was found to cause a slight irritation when applied to intact and abraded rabbit skin.
Eye irritation
The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. TK 12871 was found to cause a minimal irritation (primary irritation index 0.7) when applied to the rabbit eye mucosa. When the application site was rinsed, the irritation was found to be minimal (primary irritation index 0.9).
Justification for classification or non-classification
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.
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