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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
TK 12871 did not caused any sensitization in albino guinea pigs.
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:
- From October 19, 1981 to December 22, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Agents & Actions 5 (2), 174-179, 1975
- Version / remarks:
- Maurer Th., Thomann P., Weirich E.G., Hess R.
- Qualifier:
- according to guideline
- Guideline:
- other: Contact Dermatitis 4, 321-333, 1978
- Version / remarks:
- Maurer Th., Thomann P., Weirich E.G., Hess R.
- Qualifier:
- according to guideline
- Guideline:
- other: Contact Dermatitis 5, 1-10, 1979
- Version / remarks:
- Maurer Th., Thomann P., Weirich E.G., Hess R.
- Qualifier:
- according to guideline
- Guideline:
- other: Toxicology, 15, 163-171, 1980
- Version / remarks:
- Maurer Th., Weirich E.G. and Hess R.
- Principles of method if other than guideline:
- During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % solution of TK 12871 in 50 % propylenglycol / 50 % saline 0.9 %. One control group was treated with the vehicle alone ("negative control").
On the first day, injections of 0.1 ml were administered into the shaven skin of the right flank and on the back, while on the following days a single intracutaneous injection was given into the back. During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant.(vehicle : adjuvant = 1 : 1). During week 6 a challenge injection of 0.1 ml of a freshly prepared 0.1 % solution of TK 12871 in 50 % propylenglycol/ 50 % saline 0.9 % was administered into the skin of the left flank. During week 8 a subirritant dose (50 % TK 12871 in vaseline) of the test compound was applied epicutaneously under occlusive dressings which were left in place for 24 hours. - GLP compliance:
- yes
- Type of study:
- not specified
- Justification for non-LLNA method:
- The guinea pig test is already available for the registration of EU. Therefore, LLNA is not conducted.
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- - Weight at study initiation: 390-500g
- Housing: individually in Macrolon cages, type 3
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10%
- Photoperiod: 12-hrs light cycle day - No. of animals per dose:
- Ten male and ten female
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to Agents & Actions 5 (2), 174-179, 1975, Contact Dermatitis 4, 321-333, 1978, Contact Dermatitis 5, 1-10, 1979 and Toxicology, 15, 163-171, 1980 test method, no differences between the test group and the vehicle-treated controls were seen, after either intradermal or epidermal challenge application of TK 12871. TK 12871 was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs. 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 811257 and Agents & Actions 5 (2), 174-179, 1975, Contact Dermatitis 4, 321-333, 1978, Contact Dermatitis 5, 1-10, 1979 and Toxicology, 15, 163-171, 1980.A 0.1% and 50% TK12871 was used for intradermal injection and occlusively patchedrespectively, to ten male and ten female test guinea pigs to induce sensitization. The skin sensitization reactions were scored at approximately 24 hours after patch removal. At the end of study, body weight increase was observed in all animals. Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen, after either intradermal or epidermal challenge application of TK 12871. Therefore, TK 12871 was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs.
Reference
Table 1. Incidence of positive animals per group after intradermal challenge injection
|
No. of positive animals / No. of treated animals |
P |
|||
Vehicle alone |
3/20 |
> 0.01
|
|||
TK 12871 |
4/20 |
*A probability of P < 0.01 was considered to indicate a significant difference.
Table 2. Incidence of positive animals per group after occlusive epicutaneous application
|
No. of positive animals / No. of treated animals |
P |
|||
Vehicle alone |
0/20 |
> 0.01 |
|||
TK 12871 |
1/20 |
*A probability of P < 0.01 was considered to indicate a significant difference.
Table 3. Challenge reactions after occlusive epicutaneous administration of the test material
Animal No. |
m |
3751 |
3752 |
3753 |
3754 |
3755 |
3756 |
3757 |
3758 |
3759 |
3560 |
Erythema score (Draize Score) 24 hours after removal of the dressing. |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
|
Animal No. |
f |
3761 |
3762 |
3763 |
3764 |
3765 |
3766 |
3767 |
3768 |
3769 |
3770 |
Erythema score (Draize Score) 24 hours after removal of the dressing. |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 4. Mean Bodyweights and Standard Deviation (g)
|
Vehicle control |
TK 12871 |
||
male |
female |
male |
female |
|
pretest |
453/28 |
435/16 |
426/28 |
422/18 |
end of test |
625/58 |
584/68 |
685/50 |
629/42 |
Mean body weight gain |
172 |
149 |
259 |
206 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization
A 0.1% and 50% TK 12871 was used for intradermal injection and occlusively patched respectively, to ten male and ten female test guinea pigs to induce sensitization. The skin sensitization reactions were scored at approximately 24 hours after patch removal. At the end of study, body weight increase was observed in all animals. Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen, after either intradermal or epidermal challenge application of TK 12871. Therefore, TK 12871 was found to be devoid of skin-sensitizing (contact allergenic) potential inalbinoguinea-pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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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