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Diss Factsheets
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EC number: 410-210-8 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-07-08 until 1991-08-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD 406 guideline (adopted 1981) study, GLP compliance. It is unclear, if sodium lauryl sulfate treatment was done for this non-irritant test item.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- OECD Guideline No. 406, adopted May 12, 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- of April 25, 1984
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Purity: > 90%
- Physical properties: solid, red
- Storage conditions: room temperature
- Validity: March, 1996
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain (Tif: DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Age at study initiation: 10 weeks old
- Weight at study initiation: 324 to 412 g
- Housing:
- Diet: ad libitum standard guinea pig pellets
- Water: ad libitum fresh water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal Induction: 5 % in arachidis oil
Epidermal applications (induction): 30 % in vaseline
Epidermal applications (challenge): 10 % in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- Intradermal Induction: 5 % in arachidis oil
Epidermal applications (induction): 30 % in vaseline
Epidermal applications (challenge): 10 % in vaseline
- No. of animals per dose:
- 10 guinea pigs in the test group
5 guinea pigs in the control group - Details on study design:
- RANGE FINDING TESTS:
- For intradermal induction (intradermal injection): Concentrations of test article tested: 1, 3, and 5 % in arachidis oil. Since 5 % of test item in arachidis oil could be injected and was well tolerated, this concentration was used for the intradermal induction.
- Epidermal Applications (induction and challenge): The following concentrations of the test item have been examined on separate animals for the determination of the maximum subirritant concentration: 1, 5, 10, and 30% in vaseline. The tested concentrations did not induce erythema reactions.
The following concentrations were used for epidermal induction: 30 % test item in vaseline.
The following concentrations were used for epidermal challenge: 10 % test item in vaseline. Because a higher concentration may lead to nonspecific reactions in adjuvant treated animals.
MAIN STUDY
A. INDUCTION EXPOSURE
- The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure
over the injection sites one week later
- First induction week, intradermal injection
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea
pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test article in 01. arachidis (w/v)
- test article in the adjuvant saline mixture (w/v)
- Second induction week, epidermal application
In the second week of induction the test item was incorporated in vaseline (w/w) and applied on a filterpaper patch to the neck
of the animals (patch 2x4 cm; approx. 0.4 g paste per patch; occluded administration for 48 hours)
- Sodium lauryl sulfate (SLS) treatment: unclear; the study report mentions SLS only under "observations" (but not under "test procedure"): "... irritant reactions are normally induced by the adjuvant, the high test article concentration, or the sodium lauryl sulfate pretreatment".
- Rest period: During weeks 3 and 4 no treatments were performed
B. CHALLENGE EXPOSURE (week 5)
- The animals were tested on the flank with the test item in vaseline (w/w) and the vehicle alone (patch 2x2 cm; approx. 0.2 g paste per patch; occluded administration for 24 hours).
- Evaluation (hr after challenge): 24 and 48
C. CONTROL GROUP
A control group of 10 animals (5 m/5 f) was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals. - Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene
Results and discussion
- Positive control results:
- The sensitivity of the strain is checked every six months with a known sensitiser. In this assay 2,4-dinitrochlorobenzene revealed the expected results indicating the sensitivity and suitability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 % (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 % (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 % (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 % (challenge). No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 % (challenge)
- 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: 10 % (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 % (challenge)
- 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: 10 % (challenge). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1 % 1-Chloro-2,4-dinitrobenzene (challenge)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 % 1-Chloro-2,4-dinitrobenzene (challenge). No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1 % 1-Chloro-2,4-dinitrobenzene (challenge)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1 % 1-Chloro-2,4-dinitrobenzene (challenge). No with. + reactions: 10.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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