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EC number: 277-475-8 | CAS number: 73455-75-1
- 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
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:
- weight of evidence
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in accordance with OECD guideline 406 with acceptable deviations.
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:
- yes
- Remarks:
- ; additional observations of the skin reactions 24 h after 1st challenge as well as 24 h after rechallenge was made.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 108300-90-9
- Cas Number:
- 108300-90-9
- IUPAC Name:
- 108300-90-9
- Details on test material:
- - Substance No.: 85/565
- Physical state: blue powder
- Analytical purity: 95 %
- Lot/batch No.: P. 1+2 / 1985
- Storage condition of test material: cooling
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White, Dunkin Hartley HOE DHPK
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal, Germany
- Weight at study initiation: 252 - 307 g
- Housing: 5 animals per cage in makrolon cages, type IV
- Diet: Kliba 341.4 mm Kaninchen-Meerschweinchen-Haltungsdiät (Klingentalmühle, Kaiseraugst, Switzerland), ad libitum
- Water: tap water, supplemented with 2 g ascorbic acid per 10 l water, ad libitum
- Acclimation period: at least 7 days before beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70 %
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 5 % in aqua dest. / resp. in Freund´s adjuvant/aqua dest.
Epicutaneous induction: 60 % in aqua dest.
1. challenge: 60 % in aqua dest. (non-irritating concentration)
2. challenge: 60 % in aqua dest. (non-irritating concentration)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 5 % in aqua dest. / resp. in Freund´s adjuvant/aqua dest.
Epicutaneous induction: 60 % in aqua dest.
1. challenge: 60 % in aqua dest. (non-irritating concentration)
2. challenge: 60 % in aqua dest. (non-irritating concentration)
- No. of animals per dose:
- 10 animals in each control group
20 animals in the test group - Details on study design:
- RANGE FINDING TESTS:
Amount applied :
2 x 2 cm filter paper strips were applied to the skin of the flanks under an occlusive dressing. The animals were exposed to about 0 .15 g of the test substance formulation.
Exposure period :
The test substance was applied 2 times for 24 hours within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitization reaction but could possibly be attributed to a shift in the irritation threshold .
Site of application :
- flank, respective on the same area
Number of test animals:
- 4 per test concentration
Readings :
- about 24 and 48 h after the beginning of application
Assessment of skin findings:
1. Erythema and eschar formation:
a) No erythema = 0
b) Very slight erythema (barely perceptible) = 1
c) Well-defined erythema = 2
d) Moderate to severe erythema = 3
e) Severe erythema (beet redness) to slight eschar formation ( injuries in depth) = 4
2. Edema formation
a) No edema = 0
b) Very slight edema (barely perceptible) = 1
c) Slight edema (edges of area well defined by definite raising) = 2
d) Moderate edema (raised approximately 1 mm) = 3
e) Severe edema (raised more than 1 mm and extending beyond the area of exposure) = 4
MAIN TEST:
Induction:
Intradermal induction:
- 6 intradermal injections in groups of two per animal
Injections for the test group :
A) front row : 2 injections each of 0 .1 ml Freunds adjuvant without test substance emulsified with water in a ratio of 1:1
B) middle row : 2 injections each of 0 .1 ml of the test substance formulation
C) back row : 2 injections each of 0 .1 ml Freunds adjuvant/water (1:1) with test substance
Injections for control groups 1 and 2:
- The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent .
Site of application :
- shoulder
Readings :
- 24 h after the beginning of application
Assessment of the skin findings:
- analogous to the pretest
Percutaneous induction :
- Percutaneous induction was carried out one week after intradermal induction
Amount applied :
2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing. The animals were exposed to about 0 .3 g of the testsubstance formulation .
- The control animals were not treated since the distilled water used as formulating agent was not expected to influence the result of the study.
Duration of exposure :
- 48 hours
Site of application :
- shoulder, same area as in the case of the previous intradermal application
Readings :
- about 48 h after the beginning of application
Assessment of skin findings:
- analogous to the pretest
Challenge:
Test concentration : non-irritant concentration
First challenge about 14 days after percutaneous application, second challenge one week later .
Amount applied :
2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing.The animals were exposed to about 0 .15 g of the test substance formulation.
1st challenge :
- treatment of the test group and of control group 1 with the test substance formulation (control group 2 remained untreated)
2nd challenge :
- treatment of the test group and of control groups 1 and 2 with the test substance formulation
Duration of exposure :
- 24 hours
Site of application :
- intact clipped flank
After the challenges residues of the test substance were wiped off with ethanol resp. ethanol/water (1:1).
Readings :
- about 24, 48 and 72 h after the beginning of application
Assessment of skin findings :
- analogous to the pretest
EVALUATION
(Based on the criteria of Annex VI/II D of the Council Directive of July 29, 1983 for the 5th Amendment of the Directive 67/548 EEC (= 83/467 EEC) )
The number of animals sensitized is primarily taken into account in the evaluation. The control animals are used to rule out a substance-induced primary skin irritation.
The findings obtained 48 hours after application are taken into account for the determination of the sensitization rate.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: 1st control group
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: 1st control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: 1st control group
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: 1st control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- other: 1st control group
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: other: 1st control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- very slight (4/10) to well defined (6/10) erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 % in aqua dest.. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: very slight (4/10) to well defined (6/10) erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: 1st control group
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: 1st control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: 1st control group
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: 1st control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- other: 1st control group
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: other: 1st control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- other: 2nd control group
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- well defined erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: other: 2nd control group. Dose level: 60 % in aqua dest.. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: well defined erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: 2nd control group
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: other: 2nd control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- other: 2nd control group
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: other: 2nd control group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- very slight erythema
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 60 % in aqua dest.. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: very slight erythema.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 60 % in aqua dest.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 60 % in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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