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EC number: 479-940-2 | CAS number: 613246-75-6
- 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
Based on the findings in this guinea pig maximisation test Sika Hardener LJ is not sensitising to the skin.
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:
- 2005-03-03 - 2005-03-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17th 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- July 30th 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- August 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig maximisation test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: LAB-ÁLL Bt. Budapest, 1174 Hunyadi u. 7.
- Housing: Animals were housed in macrolon cages (42 x 42 x 19 cm), with 3 or 2 animals/ cage
- Diet: PURISTAR standard diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 29 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30 - 70
- Air changes (per hr): 8 - 12
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Oleum helianthi
- Concentration / amount:
- intra-dermal Induction: 0.1 mL of the test item (5%) homogenized in oleum helianthi
dermal induction: 0.5 mL of test item (in undiluted state)
challenge: 0.5 mL of test item (in undiluted state) - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Oleum helianthi
- Concentration / amount:
- intra-dermal Induction: 0.1 mL of the test item (5%) homogenized in oleum helianthi
dermal induction: 0.5 mL of test item (in undiluted state)
challenge: 0.5 mL of test item (in undiluted state) - No. of animals per dose:
- test group: 10 animals treated with test item, 10 animals treated with reference material
control group: 5 animals treated with test item, 5 animals treated with reference material - Details on study design:
- RANGE FINDING TESTS:
In order to specify primary irritation by intra-dermal injection and dermal application a series of four dose levels each were tested. For intra-dermal injections the test item was injected at concentrations of 0.01, 0.1, 1, and 5 % (w/v). The dermal applications were conducted with 25, 50, 75% (w/v) and an undiluted state. 0.1 mL of the test item was used as test volume for injection and 0.5 mL were used for the dermal application.
As a result of these preliminary testings, the test item was formulated and used at a concentration of 5% for intra-dermal treatment and used in undiluted state for dermal induction treatment and challenge application.
MAIN STUDY
A total of 10 test animals were subjected to sensitisation procedures in a two-stage operation, i.e. an intra-dermal treatment and a topical application. The test item was administered at a concentration of 5% for intradermal injections and in undiluted state for dermal sensitisation treatments. The test area was painted with 0.5 mL of 10% sodium dodecyl sulphate in vaseline 24h prior to the topical induction application in order to create a local irritation. Two weeks following the last induction exposure a challenge dose (in undiluted state) was administered. Challenge was performed by dermal application of the test item. - Challenge controls:
- Control animals were treated similarly to test animals, except that the test item was omitted in the induction phase.
- Positive control substance(s):
- yes
- Remarks:
- potassium dichromate
- Positive control results:
- In the test group 10 animals were treated with the reference item. After the challenge with the reference item potassium dichromate, positive responses were seen in five out of ten animals in the treatment group (50%). Dermal scores represented patchy and confluent erythema, which had developed on the skin of sensitised guinea pigs (score 2). The opposite (right) flanks of animals, treated with vehicle only, showed no reaction. Five control animals were exposed to the vehicle of induction treatment and treated with the reference item for the challenge. No visible changes were recorded 24 hours and 48 hours after challenge initiation. During challenge exposure, the reference item potassium dichromate (in concentration of 0.3 %) did not evoke primary irritation.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3 % potassium dichromate
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- patchy and confluent erythema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3% potassium dichromate
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- patchy and confluent erythema
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- patchy erythema
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- patchy erythema
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the findings in this guinea pig maximisation test Sika Hardener LJ is not sensitising to the skin.
- Executive summary:
A guinea pig maximisation test (GPMT) was performed with a total of 10 guinea pigs according to the Magnusson-Kligman method, using Freund's complete adjuvant technique, to evaluate the sensitisation potential of test item Sika Hardener LJ. The undiluted test substance was applied topically to the intact skin of 10 (test group) respectively 5 (negative control group) rabbits after intra dermal induction by 5% dilution of the test substance (test group) or the vehicle only (negative control group). The test area was painted with 0.5 ml of 10 % sodium dodecyl sulphate in vaseline 24 h prior to the topical induction application in order to create a local irritation. Two weeks following the last induction exposure the challenge dose (in undiluted state) was administered. The results were read after 24h and 48h. Positive responses were observed in 20 % of the test animals after challenge with the test item. Challenge with the test item elicited patchy erythema on the skin surface of previously sensitised guinea pigs (score 1). There were no responses indicating skin sensitisation in the negative control group. Based on these findings the test substance is not sensitising to the skin. (LAB, 2005)
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A guinea pig maximisation test (GPMT) was performed with a total of 10 guinea pigs according to the Magnusson-Kligman method, using Freund's complete adjuvant technique, to evaluate the sensitisation potential of test item Sika Hardener LJ. The undiluted test substance was applied topically to the intact skin of 10 (test group) respectively 5 (negative control group) rabbits after intra dermal induction by 5% dilution of the test substance (test group) or the vehicle only (negative control group). The test area was painted with 0.5 ml of 10 % sodium dodecyl sulphate in vaseline 24 h prior to the topical induction application in order to create a local irritation. Two weeks following the last induction exposure the challenge dose (in undiluted state) was administered. The results were read after 24h and 48h. Positive responses were observed in 20 % of the test animals after challenge with the test item. Challenge with the test item elicited patchy erythema on the skin surface of previously sensitised guinea pigs (score 1). There were no responses indicating skin sensitisation in the negative control group. Based on these findings the test substance is not sensitising to the skin. (LAB, 2005)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data on sensitisation Sika Hardener LJ ist not subjected to classification and labelling according according to Regulation (EC) No 1272/2008, as amended for the fifteenth time in Regulation (EU) No 2020/1182.
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