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EC number: 944-584-3 | 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
Endpoint summary
Administrative data
Description of key information
Skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From March 14 to April 08, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A LLNA study has not been conducted because adequate data from guinea pig Maximisation test study are already available.
- 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
- Females (if applicable) nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known:
- Age at study initiation:
- Weight at study initiation: between 335 to 418 g
- Housing: individually in Macrolon cages (Type 3)
- Diet (e.g. ad libitum): standard guinea pig pellets - NAFAG No. 845, Gossau SG ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:
- Indication of any skin lesions:
- Randomisation: assigned to the different groups by means of random numbers generated by the random number generator, identified by individual ear tags
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 to 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Physiological saline and Bacto Adjuvant, Complete, Freund
- Concentration / amount:
- 5 % for Intradermal injection
50 % for epidermal application - Day(s)/duration:
- day 0 for intradermal injection and 8 for epidermal applicxation
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 10 %
- Day(s)/duration:
- Day 22
- No. of animals per dose:
- 5 male and 5 female in the test group
5 male in the control group - Details on study design:
- RANGE FINDING TESTS:
Intradermal Induction
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest.
The following concentration of test article has been used for intradermal injection:
5% in physiological saline (w/v).
Since 5% of test substance in physiological saline could be injected and was well tolerated, this concentration was used for the intradermal induction.
Epidermal Applications (induction and challenge)
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations have been examined on separate animals for the determination of the maximum subirritant concentration:
- 10, 20, 30, and 50% in physiological saline.
50% was the highest possible concentration of the test article in physiological saline.
Reactions were observed with 20, 30, and 50% in physiological saline
MAIN STUDY
A. INDUCTION EXPOSURE:
DAY 0: INDUCTION, intradermal injections
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5% FAT 21061/C in physiological saline (w/v)
- 5% FAT 21061/C in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- physiological saline
DAY 8: INDUCTION, epidermal application
In the test group the test substance was incorporated in physiological saline and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours).
The control group was treated with the vehicle only.
Test group:
- 50% FAT 21061/C in physiological saline
Control group:
- physiological saline only
B. CHALLENGE EXPOSURE: day 22
The test and control group animals were tested on one flank with the test substance in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours).
Test and control group:
- 10% FAT 21061/C in physiological saline
- physiological saline only - Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
- Positive control results:
- Test and results fullfill the requirements for reliability check of the OECD Guideline 406.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Interpretation of results:
- other: Category 1B (indication of skin sensitising potential) based on CLP criteria
- Conclusions:
- Skin sensitising
- Executive summary:
Method
The test substance was evaluated for its skin sensitisation potential using the "Guinea Pig Maximisation test", as described in the OECD Guideline 406.
Results
Under the experimental conditions employed, 70 % and 80 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings, respectively.
Body weights were not affected by treatment.
Conclusion
The test substance for this test is considered as a skin sensitiser.
Reference
Observations and records
Induction reactions
After the intradermal and the epidermal induction application irritant reactions are normally induced by the adjuvant and the
high test article concentration. Because most of the reactions are treatment related and not compound related, the reactions
are only described in special cases in the section of results.
Challenge reactions
Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize
scoring scale.
General
The body weight was recorded at start and end of the test.
Interpretation of results
The sensitising potential of the test susbtance was classified according to the grading of Magnusson and Kligman.
According to the guide to the labelling of dangerous substances and the criteria for the choice of sentences indicating particular hazards (R sentences) attributed to dangerous substances (Commission Directive 93/21/EEC, April 27, 1993) a test article was classified as a sensitiser in the case where a positive response was noted in at least 30 % of the animals.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
SKIN SENSITIZATION
Category 1
Substances shall be classified as skin sensitizers in category 1 where data are not sufficient for sub-categorisation in accordance with the following criteria:
(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or
(b) if there are positive results from an appropriate animal test.
Specific criteria of animal test:
when an adjuvant type test method for skin sensitisation is used, a response of at least 30 % of the animals is considered as positive.
For a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive.
Furthermore, stimulation index of three or more is considered a positive response in the local lymph node assay.
Sub-category 1A
Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.
Specific criteria:
Local lymph node assay-EC3 value ≤ 2 %
Guinea pig maximisation test-≥ 30 % responding at ≤ 0,1 % intradermal induction dose or ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose
Buehler assay - ≥ 15 % responding at ≤ 0,2 % topical induction dose or ≥ 60 % responding at > 0,2 % to ≤ 20 % topical induction dose
Sub-category 1B
Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.
Local lymph node assay - EC3 value > 2 %
Guinea pig maximisation test- ≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose.
Buehler assay - ≥ 15 % to < 60 % responding at > 0,2 % to ≤ 20 % topical induction dose or ≥ 15 % responding at > 20 % topical induction dose.
Based on animal test (Guinea pig maximisation test) results performed, according to the paragraph 3.4. of the CLP Regulation n. 1272/2008, the test substance is Classified in Sub category 1B, as 8 animal were positive after treatment (intradermal dose = 5 % of test substance).
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