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EC number: 274-503-0 | CAS number: 70247-74-4
- 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
The test substance did not show a skin - sensitizing (contact allergenic) potential in albino guinea pigs.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 January 1994 - 17 May 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Reason for selection
The maximisation test has been selected , because i t is one of the recommended tests in th e OECD guidelin e 406, adopted May 12, 1981, adapted July 17, 1992, a s well a s in Annex V, Part B
of Council Directiv e 67/548/EEC (Commission Directive 92/69/EEC of Jul y 31, 1992), and because the sensitivit y of the method is well known. The test has been performed in essence according to the origina l protoco l of Magnusson and Kligman (J. invest .Dermatol. 52, 268-276, 1969; Contac t Dermatitis 6, 46-50,1980). - Specific details on test material used for the study:
- Code number: FAT - 20'035/C
EN-Nr.: 140200.31
Appearance: solid
Solubility: 20g/l [in water]
Storage: room temperature
Expiration date: 10/98 - Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein / Switzerland
- Weight at study initiation:310 to 449 g.
- Housing: The animals were housed individually in Macrolon cages (Type 3)
- Diet: ad libitum standard guinea pig pellets -NAFAG No. 845, Gossau SG
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%):30 to 70
- Photoperiod (hrs dark / hrs light): a 12 hours light cycle day. - Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 % / 0.1 ml
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 50 % / patch 2x4 cm; approx. 0.4 g per patch
- Day(s)/duration:
- Day 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 30 % / patch 2x2 cm; approx. 0.2 g per patch
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 per sex
- Details on study design:
- Test procedure:
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 20035/C in physiological saline (w/v)
- 5 % FAT 20035/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
The application site of all animals was pretreated with 10 % sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application.
In the test group FAT 20035/C was incorporated in physiological saline and applied on a filter paper 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 20035/C in physiological saline
Control group:
- physiological saline only
DAY 21: Challenge
The test and control group animals were tested on one flank with FAT 20035/C in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 2 4 hours).
Test and control group:
- 30 % FAT 20035/C in physiological saline
- physiological saline only - Challenge controls:
- The test and control group animals were tested on one flank with FAT 20035/C in physiological saline and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 2 4 hours).
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole puriss
- Positive control results:
- None
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Erythema in one animal
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 30 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 2-Mercaptobenzothiazole puriss
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Erythema and edema
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 2-Mercaptobenzothiazole puriss
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20035/C did not show a skin - sensitising (contact allergenic) potential in albino guinea pigs.
- Executive summary:
A GLP-compliant study was performed to detect the sensitisation potential of FAT 20035/C in the guinea pig maximisation test, by following the OECD Guideline No. 406, adopted May 12, 1981 and on Annex V, Part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992). During induction phase on zero day test substance was delivered by 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. On day 8 of induction epidermal application of the test substance was done. In the test group FAT 20035/C was incorporated in physiological saline and applied on a filter-paper 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. And in the Challenge phase the test and control group animals were tested on one flank with FAT 20035/C 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).
No animal of the test group was sensitised by FAT 20035/C under the experimental condition employed. FAT 20035/C did not show a skin - sensitising (contact allergenic) potential in albino guinea pigs.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A key study was performed in compliance with GLP guidelines according to the OECD Guideline No. 406. During induction phase on zero day test substance was delivered by intradermal injections. On day 8 of induction epidermal application of the test substance was done, and in the Challenge phase the test and control group animals were tested on one flank with FAT 20035/C in physiological saline and on the other flank with the vehicle alone. No animal of the test group was sensitised by FAT 20035/C under the experimental conditions employed. According to the EEC classification criteria (Commission Directive 93/21/EEC, April 27, 1993) FAT 20035/C did not show a skin - sensitizing (contact allergenic) potential in albino guinea pigs.
In a supporting study, which was performed as per the method recommended in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO), demonstrated no difference between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis. Hence, at 30 % epidermal application there was no sensitising potential considered with FAT 20035/B.
Another supporting study showed twenty percent of the animals were sensitized by FAT 20'035/B (purity: not known) under the experimental conditions employed. According to the maximization grading FAT 20035/B showed a mild skin-sensitizing (contact allergenic) potential in albino guinea pigs.
Considering the results from all the three studies it can be concluded that FAT 20035 is non-sensitising.
Migrated from Short description of key information:
FAT 20035/C did not show a skin - sensitising (contact allergenic) potential in albino guinea pigs.
Justification for selection of skin sensitisation endpoint:
GLP guideline study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the finding of the skin sensitisation study, the test substance does not need to be classified according EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.
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