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Diss Factsheets
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EC number: - | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 05 May - 04 June 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study, tested with the source substance CAS 16470-24-9. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
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 Ltd. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: approximately 10 weeks old
- Weight at study initiation: between 313 to 422 g
- Housing: individually housed in Macrolon cages (Type 3)
- Diet: standard guinea pig pellets NAFAG No. 846, Gossau SG, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: guinea pigs were reported to be acclimatized, but number of days was not reported
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 hours light cycle day
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: see concentration
- Concentration / amount:
- Concentration of the test substance in physiological saline and adjuvant mixture: 1% (intradermal induction)
Approximately 0.4 g paste of 30% test substance in vaseline (epidermal induction)
Approximately 0.2 g paste of 10% test substance in vaseline (epidermal challenge)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: see concentration
- Concentration / amount:
- Concentration of the test substance in physiological saline and adjuvant mixture: 1% (intradermal induction)
Approximately 0.4 g paste of 30% test substance in vaseline (epidermal induction)
Approximately 0.2 g paste of 10% test substance in vaseline (epidermal challenge)
- No. of animals per dose:
- 10 males and 10 females per group
- Details on study design:
- INDUCTION PROCEDURES
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, intradermal application:
Three pairs of intradermal injections (0.1 mL per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant and saline (1:1)
- test compound in physiological saline
- test compound in the adjuvant saline mixture
Concentration of in physiological saline and adjuvant mixture: 1%
Second Induction, epidermal application:
One week later the test substance was incorporated in vaseline and applied on a filter paper patch to the neck of the animals (patch 2 x 4 cm; occluded administration for 48 hours). The application sites were pretreated the day before with 10% sodium lauryl sulfate (open application). Dose of application: approx. 0.4 g paste of 30% test substance in vaseline.
CHALLENGE
Two weeks after the epidermal induction application the animals were tested on the flank with test substance in vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 hours). Dose of application: approx. 0.2 g paste of 10% test substance in vaseline. The concentrations of the test compound for the induction and challenge periods were determined on separate animals.
CONTROL GROUP
A control group was treated with adjuvant and the vehicle during the induction period.
IRRITATION POTENTIAL
Separate animals were treated with test item for the evaluation of the primary irritation threshold concentration. The tested concentrations of 10 and 30% of test item in vaseline did not induce erythema reactions. 10% was used as a sub-irritant concentration for the challenge application, to exclude nonspecific reactions in the adjuvant treated animals (s. Magnussen, 1980).
OBSERVATIONS and RECORDS
Twenty four hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale.
A second evaluation was made 48 hours after removing the dressings. The sensitizing potential of the test compound was classified according to the grading of Magnusson and Kligman. The body weight was recorded at start and end of the test. - Challenge controls:
- A control group 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 compound (at least 10 animals) to control the maximal sub-irritant concentration of the test compound in adjuvant treatedanimals.
- Positive control substance(s):
- yes
- Remarks:
- Paraphenylene-diamine or Potassium-dichromate.
Results and discussion
- Positive control results:
- The sensitivity of the strain is checked every six months with Paraphenylene-diamine or Potassium-dichromate. The results of the latest reliability check was not provided in the report.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Any other information on results incl. tables
Under the experimental conditions employed, 0% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
Number of positive animals per group after occlusive epicutaneous application:
after 24 hours | after 48 hours | |
Control group | ||
vehicle control | 0/20 | 0/20 |
test compound | 0/20 | 0/20 |
Test group | ||
vehicle control | 0/20 | 0/20 |
test compound | 0/20 | 0/20 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
Method
A sensitization test in albino guinea pigs was performed to determine the contact allergenic potency of the test compound in albino guinea pigs. This test was based on the OECD Guideline No. 406, adopted May 12, 1981, by the OECD council.
Results
Under the experimental conditions employed, 0 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
Conclusion
According to the CLP Regulation, a substance is classified as skin sensitiser when in the Guinea pig maximisation test the response of at least 30 % of the animals is considered as positive.
In the current experiment none of the animals tested showed any skin reaction.
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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