Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 438-600-3 | CAS number: 110675-26-8
- 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
![](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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study. According to ECHA guidance, a study with a read-across substance can have no reliability of higher than 2. The study itself is valid without restriction.
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)
- Version / remarks:
- (adopted May 12, 1981)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Batch #: Vers. 31-33
- Purity: pilot sample
- Storage: room temperature
- Physical state: liquid
- Expiry date: September 1991
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, Sisseln, Switzerland
- Age at study initiation: no data
- Mean weight at study initiation: males = 382.7 g; females = 376.1 g
- Housing: housed individually in Macrolon cages (Type 3)
- Diet: ad libitum; standard guinea pig pellets -NAFAG No.847, Gossau SG (assayed for nutritive ingredients and contamination level by the manufacturer)
- Water: ad libitum (drinking water was examined periodically by the IWB (Industrielle Werke Basel)
- Acclimation period: 8 days
- Rationale for choice: The albino guinea pig is the recommended species for skin sensitization studies.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Sesame oil (Intradermal induction), Vaseline (epicutaneous induction and challenge)
- Concentration / amount:
- Intradermal induction: 1%
epicutaneous induction: 30%
challenge: 3%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sesame oil (Intradermal induction), Vaseline (epicutaneous induction and challenge)
- Concentration / amount:
- Intradermal induction: 1%
epicutaneous induction: 30%
challenge: 3%
- No. of animals per dose:
- Test group : 20 animals
control group: 20 animals - Details on study design:
- RANGE FINDING TESTS:
Separate animals were treated with the test article for the evaluation of the primary irritation threshold concentration. 10 % in Vaseline induced erythema reactions. 3 % in Vaseline did not induce skin reactions and, therefore, this concentration was used as the maximal sub-irritant concentration for the challenge applications.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Injection
- Site/Area: Neck region/2 x 4 cm
- No. of injections/animal: 3 pairs
- Test substance group (cranial; 2 injections side by side): Freund's complete adjuvant (FCA) blended (1:1, v/v) with physiol. saline
- Test substance group (middle; 2 injections side by side): The test article (1%) in sesame oli
- Test substance group (caudal; 2 injections side by side): Freund's complete adjuvant blended (1:1, v/v) with physiol. saline + 1 % test article in vehicle.
- Control group (cranial; 2 injections side by side): Freund's complete adjuvant (FCA) blended (1:1, v/v) with physiol. saline
- Control group (middle; 2 injections side by side): Sesame oil
- Control group (caudal; 2 injections side by side): Freund's complete adjuvant blended (1:1, v/v) with physiol. saline + 1 % test article in vehicle.
- Volume per injection: 0.1 ml
- Evaluation (hr after injection): from 24 hour till day 7
- Exposure period: Single exposure
Epicutaneous induction exposure
- Time schedule: 1 week after intradermal injection
- Site: same site as intradermal injections
- Frequency of applications: Once.
- Area of application: 2 x 4 cm (filterpaper patch)
- Concentrations: 30% (test group), vehicle (control group)
- Amount applied: approx. 0.4 g paste of test substance in vaseline
- Type of coverage: occlusive
- Duration: 48 hours
- Evaluation (hr after challenge): directly after removal of patch
B. CHALLENGE EXPOSURE (all animals i.e treated animals and control animals)
- Time schedule: 2 weeks after termination of epicutaneous induction exposure
- Site: flank
- Area of application: 2 x 2 cm (filterpaper patch)
- Concentrations: 3%
- Amount applied: 0.2 g paste of test substance in vaseline (one flank) and vaseline (other flank)
- Type of coverage: occlusive
- Duration: 24 hours
- Evaluation (hr after challenge): 24 and 48 hours after termination of exposure
B.2. RECHALLENGE EXPOSURE
After the standard challenge exposures, 6 animals of the test group showed very slight skin reactions 24 and 48 hours. Because all the reactions observed were mild, a second challenge application was performed after a further period of 1 week.
SCORING SYSTEM: Draize in Appraisal of the Safety of chemicals in Foods, Drugs and Cosmetics (1959), The US Association of Food and Drug Officials (AFDO).
Erythema and eschar formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema formation:
No oedema: 0
Very slight edema (barely perceptible): 1
Slight edema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1 millimetre): 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4 - Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the assay was checked every six months with Paraphenylene-diamine or Potassium-dichromate
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 3%
- 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: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 3%
- 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: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 7.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Average body weights at termination
- males = 656 g
- females = 526.1 g
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Vi har mycket webbmaterial på ditt språk, men en del av den här sidan finns bara på engelska. Mer om vår flerspråkighetspolicy finns.
Välkommen till Echas webbplats. Alla funktioner på den här webbplatsen fungerar inte med Internet Explorer 7 (eller tidigare versioner). Det är därför bäst att du uppgraderar till en nyare version.
På den här webbplatsen används kakor. Syftet är att optimera din upplevelse av den.
Läs mer om hur vi använder kakor.