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EC number: 215-403-9 | CAS number: 1325-65-1 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 40290.
- 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)
- Remarks:
- in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Source study has reliability 1. Details on the read across are attached in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 92/69 EEC B6
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Guinea pig maximisation test was available
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: 5-8 weeks
- Weight at study initiation: control and test group: 341-489 g. Pretest 317-435 g
- Housing: individually
- Diet: pelleted standard Kliba 342, Batch no 68/95 guinea pig breeding/maintenance diet, ad libitum
- Water: community tap water from Füllinsdorf, ad libitum. Once weekly additional supply of ascorbic acid (1 g/l) via the drinking water.
- Acclimation period: one week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretest. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 21-23 °C
- Humidity: 48-60 %
- Air changes: 10-15 per hr
- Photoperiod: 12 hour light, 12 hour dark cyle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- Test:
FCA : phys. saline 1:1
5 % bi-distilled water
5 % FCA : phys. saline 1:1
Control:
FCA : phys.saline 1:1
bi-distilled water
FCA : phys. sal. 1:1/bi-distilled water - Day(s)/duration:
- day 1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- - 25 % bi-distilled water
- Day(s)/duration:
- day 8
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 15 % bi-distilled water
- Day(s)/duration:
- day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Control group: 10 males
Test group: 20 males
Intradermal pretest: 2 males
Epidermal pretest: 4 males - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three pairs of intradermal injections
- Exposure period: 7 days
- Test groups:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline
2) test article, diluted to 5 % with bi-distilled water
3) test article diluted to 5 % by emulsion in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Control group:
1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline
2) bi-distilled water
3) 1:1 (w/w) mixture of bi-distilled water in a 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
- Site: dorsal skin from the scapular region (approximaterly 6 × 8 cm) was clipped free of hair.
- Frequency of applications: 1 week
- Duration: 48 h
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 22
- Exposure period: 24 - 48 h
- Site: hair was clipped and shaved from a 5 × 5 cm area on the left and right flank of each guinea-pig just prior to the application.
- Concentrations: 2 patches ( 2 × 2 cm) of filter paper were saturated with the highest non-irritating concentration of 15 % (left flank) and the vehicle only (bi-distilled water, applied to the right flank) using the same method as for the epidermal application.
- Duration: 24 h
- Evaluation: 24 and 48 h after removal of the dressing - Positive control substance(s):
- yes
- Remarks:
- 4-aminobenzoic acid ethyl ester and 2- mercaptobenyothiazol
Results and discussion
- Positive control results:
- For validation of sensitivity, a known sensitizer (2-mercaptobenzothiazol) was selected as a positive control.
In this study, 95 % and 90 % of animals of test group were observed with positive skin reactions at the 24- and 48-hour reading respectively after treatment with a non-irritant test substance concentration of 5 % in peanut oil. No skin reactions were observed in the control group. The results obtained with test article at 10 % in peanut oil were not taken into consideration since both control group were observed with erythematous reactions.
A known mild sensitizer was also selected as a positive control (4-aminobenzoic acid ethyl ester). In this study 30 % and 35 % of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test substance concentration of 30 % in mineral oil. No skin reactions were observed in the control group.
The response of at least 30 % positive animals is considered positive.
Test article 2-mercaptobenzothiazol at concentration of 5 % in peanut oil is considered an extreme sensitiser.
Test article 4-aminobenzoic acid ethyl ester at concentration of 30 % in mineral oil is considered a moderate sensitiser.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15 % in bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- erythema and edema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15 % in bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- erythema and edema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- vehicle, bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- erythema and edema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- vehicle, bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- erythema and edema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle, bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- erythema and edema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle, bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- erythema and edema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15 % in bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- erythem and edema
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 15 % in bi-distilled water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- erythema and edema
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
After epidermal induction, due to orange-red discoloration produced by test substance, a possible erythema reaction could not be determined.
Viability / mortality / macroscopic findings: as there were no deaths during the treatment period, no necropsies were performed.
Clical signs, systemic: no symptoms of systemic toxicity were observed in the animals.
Body weight: 2 out of 10 animals of the control group (nos. 325, 330) and 1 out of 20 animals of the test group (no. 346) incidentally lost weight during the acclimatisation period. No weight loss was observed during treatment period.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not skin sensitiser.
- Executive summary:
Method
A guinea pig maximisation test was carried out to assess the allergenic potential of the substance. Ten males were used as control group and 20 males were used as test group.
Before the main test, a pretest was performed in order to identify a maximally tolerated concentration of test article suitable for the induction phase of the main study. In addition, a suitable non-irritant concentration of test article, by the topical route of administration, was identified for the challenge application.
The pretest was performed by intradermal (0.1 ml/site, at concentrations of 1, 3 and 5 % of test article in bi-distilled water) and epidermal route (5, 10, 15 and 25 % of test material in bi-distilled water).
Based on pretest findings:
- application a 5 % test substance dilution in bi-distilled water was selected for intradermal induction
- 25 % test substance in bi-distilled water was selected for the induction application and 15 % test substance in bi-distilled water was selected for the challenge application.
Results
None of the animals of the test group showed positive skin reactions responding to a 5 % intradermal induction dose. Therefore, test substance was considered as not skin sensitising.
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