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EC number: 610-949-8 | CAS number: 53045-70-8
- 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
The purpose of this GLP study performed according to OECD GL 406 was to assess the contact sensitisation potential of the test material in guinea pigs. The test item produced a 0 % (0/10) sensitisation rate and can therefore be assessed as a non sensitiser to guinea pig skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 04, 2006 - January 18, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 07-1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- not further specified
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test material was screened for its irritating potential using the hen's egg test on the chorioallantoic membrane (HET-CAM). In this model the cumulative irritation score of the test item was 19.09, indicating strongly irritant properties. Therefore, the test item was evaluated for skin sensitizing properties in the guinea pig maximization test and not in a Local Lymph Node Assay.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: 326 - 388 g
- Housing: groups of 5 animals in type GM/5 Makrolon cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): 49 - 77
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- cranial: 0.1 mL Freund's complete adjuvant + sodium chloride solution
medial: 0.1 mL test item (1 g/L ad liquid paraffin)
caudal: 0.1 mL Freund's complete adjuvant with test item and sodium chloride solution - Day(s)/duration:
- day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Filter patch saturated with 1 mL of the test item preparation or vehicle
- Day(s)/duration:
- Application on day 7 over 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Filter papers fully loaded with 0.5 ml of the test item preparation and soaked with 0.5 mL PEG 400.
Topical induction: test item (10 g/L ad PEG 400)
Challenge: test item (5 g/L ad PEG 400)
Challenge: PEG 400 (undiluted) - Day(s)/duration:
- day 21 over 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Pretest: 5 f
Number of animals in test group: 10 f
Number of animals in negative control group: 5 f - Details on study design:
- To determine the concentrations suitable for the main study, a pre-test with intradermal or topical administrations of the vehicle and test item preparations was performed. Six intradermal injections with different concentrations were given to one animal. Four further animals were used to determine the topical concentrations for the main study. Two of the guinea pigs were exposed for 48 hours without pre-treatment to 4 different concentrations to determine the slightly irritating concentration for the dermal induction. The other two animals were treated according to the control group including intradermal injections with FCA. One week after topical induction the two animals of the pre-test group were exposed for 24 hours to 4 different test material concentrations to find out the non-irritating challenge concentration. In the pre-test the following concentrations were used:
Test item with liquid paraffin as vehicle:
no pre-treatment: intradermal injection: 50, 25, 10, 5, 1 and 0 g/L
Test item with polyethylene glycol 400 as vehicle:
no pre-treatment: topical exposure (48 hours): 200, 100, 50 and 10 g/L
pre-treatment with FCA: topical exposure (24 hours): 50, 10, 5 and 1 g/L
Clinical investigations
During the induction phase, the guinea pigs were examined on days 2, 3, 7, 11, 12, 15, and 22 of the experimental part for local skin reactions, and the results were documented. The behaviour and general condition of all animals were monitored daily. The challenge sites were investigated for reactions 48 hours after start of the challenge. Further inspections followed 72 hours after start of the challenge, to detect weak or slowly developing reactions.
Bodyweight
The body weight of the guinea pigs was determined prior to the start of the experimental part (day 1), on experimental days 8, 15, 22, and at the end of the experimental part. - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10 g/L
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 10 g/L
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study the test item can be assessed as a non sensitiser to guinea pig skin.
- Executive summary:
Study design
The test material was screened for its irritating potential using the hen's egg test on the chorioallantoic membrane (HET-CAM). In this model the cumulative irritation score of the test item was 19.09, indicating strongly irritant properties.
Therefore, the test item was evaluated for skin sensitizing properties in the guinea pig maximization test and not in a Local Lymph Node Assay. In this GLP study performed according to OECD GL 406, guinea pigs in the negative control group treated with the vehicles and animals in the test group were investigated. Induction included intradermal injection of test material preparation in liquid paraffin both with and without Freund's complete adjuvant on experimental day 1 and topical application for 48 hours of test material preparation in polyethylene glycol 400 on experimental day 8.
Challenge by topical application for 24 hours of the test material preparation in polyethylene glycol 400 was performed two weeks after topical induction and readings taken at 48 hours and 72 hours after start of treatment.
Results
After challenge no positive reactions in the test material treated skin sites at both readings were seen. The clinical behavior of the guinea pigs was normal during the experimental part and all animals survived the experimental part. The body weight development corresponded to that of the animals of the vehicle group.
Conclusion
Under the given experimental conditions, the test item showed no positive responders and has not to be classified as a sensitizer.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Based on the provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.
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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