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EC number: 259-470-2 | CAS number: 55067-15-7
- 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 sensitsiation
In the guinea pig maximization test no sensitising properties of the test substance were observed.
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:
- 1990-02-26 to 1990-03-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The purpose of this skin sensitization study was to assess the allergenic potential of the test item when administered to the skin of albino guinea pigs.
This study should provide a rational basis for risk assessment of the sensitizing potential of the test article in man. - Specific details on test material used for the study:
- - Lot/batch No.: Op. 604/89
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, Fullinsdorf, Switzerland
- Age at study initiation: 7-8 weeks (at acclimatization start)
- Weight at study initiation: males: 328-382 g, females: 330-359 g (at acclimatization start)
- Housing: individually
- Diet: ad libitum Pelleted standard Kliba 342, "Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst
- Water: tap water ad libitum, once weekly additional supply of ascorbic acid via the drinking water
- Acclimation period: one week under test conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15 - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal injections: 0.1 mL per site, test group:
1) Freund's complete adjuvant 50:50 with bi-distilled water
2) The test article, diluted to 5 % with bi-distilled water.
3) The test article at the concentration used in (2), emulsified in a 50:50 mixture of Freund's complete adjuvant and the vehicle used in (2)
Control group:
1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) Vehicle used in (2) for test group.
3) Freund's complete adjuvant 50:50 with bi-distilled water.
Epidermal application: 25 % in bidistilled water
Challenge: 25 % in bidistilled water (non-irritant concentration), vehicle only - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal injections: 0.1 mL per site, test group:
1) Freund's complete adjuvant 50:50 with bi-distilled water
2) The test article, diluted to 5 % with bi-distilled water.
3) The test article at the concentration used in (2), emulsified in a 50:50 mixture of Freund's complete adjuvant and the vehicle used in (2)
Control group:
1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) Vehicle used in (2) for test group.
3) Freund's complete adjuvant 50:50 with bi-distilled water.
Epidermal application: 25 % in bidistilled water
Challenge: 25 % in bidistilled water (non-irritant concentration), vehicle only - No. of animals per dose:
- 10 males, 10 females for the test group, 5 males, 5 females per control group
- Details on study design:
- RANGE FINDING TESTS:
Intradermal injections (0.1 mL/site) were made into the clipped flank of two guinea-pigs at concentrations of 5%, 3% and 1 % of the test article in bidistilled water. The resulting dermal reactions were assessed 24 hours later.
Epidermal applications:
Patches of filter paper ( 2 x 2 cm) were saturated with concentrations of 25%, 15%, 10% and 5% of the test article in bi-distilled water and applied to the clipped and shaved flanks of each of four guinea-pigs. The patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. This procedure ensured the intensive contact of the test article. The dressings were removed after an exposure period of 24 hours and the reaction sites were assessed for erythema and edema. To confirm the results observed at first epidermal pretest without depilating the test sites prior to the first reading, a second pretest was performed 5 days before primary challenge on a further 4 guinea pig individuals according to the same method.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: Approximately 24 hours prior to the epidermal application the test area was pretreated with 10 % Sodium-Lauryl-Sulfat (SLS) in petrolatum-oil, because no primary irritation concentration could be determined in the corresponding pretest. The SLS was massaged into the skin with a glass rod without bandaging to provoke a mild inflammatory reaction.
Epidermal application: one week after injections, a patch containing test article was applied to the shaved skin over the injection sites and fixed for an exposure time of appr. 48 hours. Reaction sites were evaluated immediately, 24 h and 48 hours after removal.
- Control group: The guinea-pigs of the control group were treated as described above with the omission of test article.
- Site: scapular region (dorsal)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: two weeks after the epidermal induction application
- Exposure period: 24 hours
- Test groups: Two patches ( 2 x 2 cm) of filter paper were saturated with a) non-irritant concentration (25 % in bi-distilled water) of the test article and b) with the vehicle only and applied to the (a) left flank and (b) right flank using the same method as for the epidermal application.
- Control group: control animals were treated in the same way.
- Site: left adn right flank
- Evaluation (hr after challenge): immediately, 24 and 48 hours - Challenge controls:
- The control animals were treated in the same way.
- Positive control substance(s):
- yes
- Remarks:
- formaldehyde
- Positive control results:
- According to the results observed it is considered that HCHO possess an extreme skin sensitizing (contact allergenic) potential in the guinea pig strain used.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 % test article dilution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- other: Reading: 1st reading. Hours after challenge: 24.0. Group: test group. Dose level: 25 % test article dilution. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No clinical signs were observed.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 % test article dilution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- other: Reading: 2nd reading. Hours after challenge: 48.0. Group: test group. Dose level: 25 % test article dilution. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No clinical signs were observed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- other: Reading: 1st reading. Hours after challenge: 24.0. Group: other: control group. Dose level: vehicle only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs were observed.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical signs were observed.
- Remarks on result:
- other: Reading: 2nd reading. Hours after challenge: 48.0. Group: other: control group. Dose level: vehicle only. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No clinical signs were observed.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- induction: 20 % HCHO, challenge: 15 % HCHO
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. Hours after challenge: 24.0. Group: positive control. Dose level: induction: 20 % HCHO, challenge: 15 % HCHO. No with. + reactions: 9.0. Total no. in groups: 10.0.
- Interpretation of results:
- GHS criteria not met
Reference
CONTROL GROUP:
No positive reactions were evident after the first challenge application, neither when treated with bi-distilled water alone nor when treated with a 25 % test article dilution.
TEST GROUP:
Immediately after removal of the challenge patches, one male animal of the test article treated test group exhibited slight erythema and slight edema (score 1). No positive reactions were evident after the first challenge application after 24 and 48 hours, neither when treated with bi-distilled water alone nor when treated with a 25 % test article dilution.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitsiation
A guinea pig maximization test was performed to assess the skin sensitising properties of the test substance. The study was conducted according to OECD Guideline 406. Irritant test article concentrations suitable for the induction phase of the main study were identified by a pretest. In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application. In the main study, ten animals (5 males, 5 females) were used as control group and 20 animals (10 males, 10 females) were used as test group. For induction, intradermal injections of 0.1 mL per site were made, containing:
1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) The test article, diluted to 5 % with bi-distilled water.
3) The test article at the concentration used in (2), emulsified in a 50:50 mixture of Freund's complete adjuvant and the vehicle used in (2).
The control group received:
1) Freund's complete adjuvant 50:50 with bi-distilled water.
2) Vehicle used in (2) for test group.
3) Freund's complete adjuvant 50:50 with bi-distilled water.
One week after the injections, patches containing 25 % test article in bidistilled water were placed over the injection sites and fixed for 48 hours. The guinea-pigs of the control group were treated as described above with the omission of test article. The test and control guinea-pigs were challenged two weeks after the epidermal induction application. Two patches of filter paper were saturated with a) non-irritant concentration (25 % in bi-distilled water) of the test article and b) with the vehicle only and applied to the (a) left flank and (b) right flank. The dressings were removed approximately 24 hours later. The sites were assessed for erythema and edema immediately, 24 and 48 hours after removal of the dressing. Control animals were treated in the same way. In the control group, No positive reactions were evident after the first challenge application. In the test group, immediately after removal of the challenge patches, one male animal of the test article treated test group exhibited slight erythema and slight edema (score 1). No positive reactions were evident after the first challenge application after 24 and 48 hours, neither when treated with bi-distilled water alone nor when treated with a 25 % test article dilution. Due to the unequivocal findings observed after the first challenge, no second challenge was performed. Additionally, results of a positive control study are available which was conducted on 10 animals using formaldehyde, which was found to produce an allergic reaction in 9 animals and therefore concluded to have an extreme skin sensitizing effect. Based on these results, the test item was determined to be non-sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008.
In the guinea pig maximization test substance was determeind to be not a skin sensitiser. As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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