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EC number: 284-660-7 | CAS number: 84961-70-6
- 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
The key study (Murmann, P 1993) examined the potential of HAB to cause sensitization to skin. A preliminary dermal irritation test was done to determine the appropriate concentration of test substance to be used. Concentrations of 2.5, 25, and 50% test substance were tried. At the 50% concentration, slight dermal irritation (erythema score of 1) was seen. However, this level of irritation was also seen in the control area for this animal. The concentration for the induction and challenge phases was therefore 50%. A group of 10 female guinea pigs were exposed to a concentration of 50% of test substance. Ten female guinea pigs were used as controls. The induction phase consisted of two intradermal injections followed by dermal application. Fourteen days later, the animals were challenged by dermal application. Mild erythema (erythema score of 1) was seen in two animals in the test group during induction phase 1 at the 6 hr reading. During induction phase 2, all animals in the test group showed erythema (maximum score of 2) at the 6 hr reading only. At the third induction phase, all animals in the treatment group also showed erythema (maximum score of 2) and 8 animals showed edema (maximum score of 1) at the 6 hr reading. At the 24 hr reading, 2 animals still showed erythema (score of 1) and edema (score of 1). In the control group, all animals showed erythema (score of 1) at the 6 hr reading after induction phase 2. No other signs of irritation were seen in the control group. No signs of irritation were seen in either the control group or treatment group at any of the challenge readings. No signs of irritation were seen in any animals during the challenge phase. Therefore, HAB is not sensitising to 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:
- Nov. 3, 1992-Dec. 2, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from LLNA method not available; study not required based on availability of more definitive in vivo data, study was performed before REACH inforcement.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Fa. Winkelman
- Age at study initiation: young adult
- Housing: 5 animals per cage, identified by skin markings
- Diet (e.g. ad libitum): Ssniff G4, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
IN-LIFE DATES: From: Nov. 3, 1992 To: Dec. 10, 1992 - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- 50%
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 50%
- No. of animals per dose:
- 10
- Details on study design:
- In the induction phase, female guinea pigs (10 guinea pigs per test concentration) were given intradermal injections of the test substance to the shoulder region. This was followed one week later with percutaneous induction, in which the animals were exposed to about 0.4 g of the test substance by applying soaked 2 x 2 cm filter paper to the skin of the same shoulders previously injected, and held in place with an occlusive dressing for 48 hours. In the challenge phase, the first challenge occurred about 14 days after the percutaneous application, and the second challenge occurred one week later. In this phase, the test material was applied using soaked 2 x 2 cm filter paper strips held in place for 24 hours with an occlusive dressing. Observations of skin reactions were made throughout the study and scored.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other:
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other:. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Group:
- positive control
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- A postive control was not conducted with every assay. Instead the sensitivity of the test system was checked at regular intervals with standard allergens, e.g. 1-chloro-2,4-dinitrobenzene.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not sensitising to skin.
- Executive summary:
This study examined the potential of the test substance to cause sensitization to skin. A group of 10 female guinea pigs were exposed to a concentration of 50% of test substance. 10 female guinea pigs were used as controls. The induction phase consisted of two intradermal injections followed by dermal application. 14 days later, the animals were challenged by dermal application. No signs of irritation were seen in any animals during the challenge phase. The test substance is not sensitising to skin.
Reference
Mild erythema (erythema score of 1) was seen in two animals in the test group during induction phase 1 at the 6 hr reading. During induction phase 2, all animals in the test group showed erythema (maximum score of 2) at the 6 hr reading only. At the third induction phase, all animals in the treatment group also showed erythema (maximum score of 2) and 8 animals showed edema (maximum score of 1) at the 6 hr reading. At the 24 hr reading, 2 animals still showed erythema (score of 1) and edema (score of 1). In the control group, all animals showed erythema (score of 1) at the 6 hr reading after induction phase 2. No other signs of irritation were seen in the control group. No signs of irritation were seen in either the control group or treatment group at any of the challenge readings.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
HAB is not a skin sensitiser based on GLP laboratory studies.
Justification for selection of skin sensitisation endpoint:
Key GLP guideline study reports experimental data
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Inhalation is not a relevant route of exposure.
Justification for selection of respiratory sensitisation endpoint:
Not a relevant route of exposure.
Justification for classification or non-classification
HAB is not irritating to the skin or eyes of laboratory animals in a GLP study; inhalation is not a relevant route of exposure.
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