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EC number: 402-580-4 | CAS number: 111439-76-0 ALKYLSILANE TZ 01748; DYNASYLAN 9405; EURENOR(R) 5020; PSX 5305
- 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:
- 19 October 1987 to 13 November 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in accordance with an acceptable scientific method.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In the maximization test the intensity of local reactions in guinea pigs after an epidermal administration (challenge) of the test compound in animals which have undergone a sensitizing treatment procedure with this compound (induction), is compared with animals which have undergone the same induction procedure with the vehicle only and serve as controls. Any clear cut stronger reaction in animals treated with ZK 119.649 should be regarded as indicative of a sensitizing potential of the test compound.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA 429 was not formally adopted by the OECD until 22 July 2010.
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- female
- Details on test animals and environmental conditions:
- Number of animals and strain: 20 Pirbright White guinea pigs
Breeder: Hagemann
Acclimatization time: > 18 days
Caging condition:conventional
Cage type: Makrolon, type III
Animals per cage: 2
Number of groups: 2, 5M/5F each
Body weight: F: 327-421 g, M: 330-447 g
Feed type: pell. Altromin MS
Feeding time: ad libitum
Type of drinking water: tap water
Watering time: ad libitum
Room temperature: 21-22°C
Relative humidity: 48-64%
Light period: 12 hours day-night cycle
Randomization: by lot
Identification: by ear marks and ear cuts - Route:
- intradermal and epicutaneous
- Vehicle:
- peanut oil
- Concentration / amount:
- Induction procedure:
Intradermal injection (Test group):
a) 0.1 ml complete Freund's adjuvant + vehicle (1+1)
b) 0.1 ml ZK 119.649; 25% w/v
c) 0.1 ml ZK 119.649; 50% w/v + complete Freund's adjuvant (1+1) = 25% w/v of ZK 119.649
Epidermal: original formulation of ZK 119.649
Challenge epidermal: 0.1 ml ZK 119.649 (50% w/v) in peanut-oil - Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- Induction procedure:
Intradermal injection (Test group):
a) 0.1 ml complete Freund's adjuvant + vehicle (1+1)
b) 0.1 ml ZK 119.649; 25% w/v
c) 0.1 ml ZK 119.649; 50% w/v + complete Freund's adjuvant (1+1) = 25% w/v of ZK 119.649
Epidermal: original formulation of ZK 119.649
Challenge epidermal: 0.1 ml ZK 119.649 (50% w/v) in peanut-oil - No. of animals per dose:
- 5 male + 5 female
- Details on study design:
- Induction procedure
Intradermal injections
In the neck region (right and left side of the spine) of each animal an overall area of 4 x 6 cm was shorn (10M/10F). A total of 6 intradermal injections, 3 on each side, were made. The 3 on each side were as follows:
A. Test group
a) 0.1 ml complete Freund's adjuvant + vehicle (1+1)
b) 0.1 ml ZK 119.649; 25% w/v
c) 0.1 ml ZK 119.649; 50% w/v + complete Freund's adjuvant (1+1) = 25% w/v of ZK 119.649
B. Control group
a) 0.1 ml Freund's complete adjuvant + vehicle (1+1)
b) 0.1 ml vehicle
c) 0.1 ml Freund's complete adjuvant + vehicle (1+1)
The injections were set within an area of 2 x 4 cm. The above mentioned concentration of ZK 119.649 did not produce necrosis and ulcerations in the guinea pigs after intradermal application in the same region as was previously proved.
Epidermal application
In order to favour the sensitizing effect of ZK 119.649, the same area of skin ( 4 x 6 cm) in which intradermal injections were performed, was reshaved on day 8 of the test and epidermally treated with approximately 1 ml sodium lauryl sulphate (10 %w/v) in liquid paraffin. 24 hours later, on day 9, 0.1 ml of original formulation of ZK 119.649 was spread over a 2 x 4 cm filter paper (Whatmann, no. 3MM) for the use in the test group, whereas for
the control group only peanuts-oil was used. Then, this filter paper was applied on the above mentioned area pretreated with sodium lauryl sulphate. The patch was bandaged occlusively for 48 hours. The original formulation of ZK 119.649 was previously proved to provoke no necrosis to the skin after epidermal administration under occlusion.
Challenge procedure
On day 23 (two weeks after the epidermal administration) a skin area of 5 x 5 cm was shorn on the right flank of each animal in both groups.
0.1 ml ZK 119.649 (50% w/v) in peanut-oil which previously proved to be locally tolerated was spread over a 2 x 2 cm piece of filter paper. This patch was placed in the middle of the shorn area of skin and bandaged occlusively for 24 hours. Reactions were recorded 24 and 48 hours after removal of the bandage. 3 hours prior to the first reading the test area was carefully shorn.
Reading and recording of local reactions
48 and 72 hours after the epidermal administration of ZK 119.649 (50% w/v) suspended in peanuts-oil in the right flank region in all animals (test group and control group), i.e. 24 and 48 hours after the occlusive bandage was removed, the local reactions were recorded according to the following scheme:
0 = neither reddening nor swelling
1 = slight reddening
2 = mild reddening
3 = severe reddening
4 = slight swelling
5 = mild swelling
6 = severe swelling
additional findings
Evaluation of findings
The types and the number of reactions in both groups were compared visually. Any clear cut increase in the animals treated with the test compound in comparison to the controls was considered as indicative of a sensitizing potential of the test compound in guinea pigs. - Challenge controls:
- No challenge controls.
For the challenge, induction controls also received the filter paper impregnated with ZK 119.649 (50% w/v) in peanut-oil. - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- ZK 119.649 (50% w/v) in peanut-oil.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: ZK 119.649 (50% w/v) in peanut-oil.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- ZK 119.649 (50% w/v) in peanut-oil.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: ZK 119.649 (50% w/v) in peanut-oil.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: Not applicable. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Not applicable
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: Not applicable. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- ZK 119.649 proved to be non-sensitising in guinea pigs in the maximization test.
- Executive summary:
The sensitising potential of the test substance was evaluated using the guinea pig maximisation test.
ZK 119.649 proved to be non-sensitising in guinea pigs in the maximization test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The sensitising potential of the test substance was evaluated using the guinea pig maximisation test. The results of this test showed the substance to be non-sensitising.
Migrated from Short description of key information:
The test substance was non-sensitising in guinea pigs in the maximization test.
Justification for selection of skin sensitisation endpoint:
Only one study is available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Migrated from Short description of key information:
No study available.
Justification for classification or non-classification
The above study has been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the study was conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the 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.
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