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EC number: 286-122-7 | CAS number: 85187-33-3
- 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
Test substance is considered as a 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April 1994 to 5 July 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 (incl. QA statement)
- 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.
- Specific details on test material used for the study:
- - Source and lot/batch number of test material: P.04.36
- Expiration date of the lot/batch: 11/98
- Appearance: Solid
- Storage conditions: room temperature - 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
- Age at study initiation: no data
- Weight at study initiation: 346 to 425 g
- Housing: individually in Macrolon cages (Type 3)
- Diet: guinea pig pellets - NAFAG No. 845, Gossau SG ad libitum
- Water: fresh water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day - Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- - 5 % FAT 40066/C in 20 % propylene glycol (w/v) with 0.1 ml per injection
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 50 % FAT 40066/C in vaseline and applied on a filterpaper patch to the neck of the animals (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
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 5 % FAT 40066/C in vaseline and on the other flank with the vehicle alone (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 male and 5 female guinea pigs in the test group and
5 female guinea pigs in the control group - Challenge controls:
- Vaseline
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole puriss
- Positive control results:
- All 20 animals treated with 2-Mercaptobenzothiazole puriss were showed reactions ctions after epidermal challenge application.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 % test substance in 20 % vehicle
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Erythema and Edema
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 % test substance in 20 % vehicle
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Erythema and Edema
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle only
- 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:
- vehicle only
- 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:
- 5 % in Oleum arachidis
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Etythema 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:
- 5 % in Oleum arachidis
- 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
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- FAT 40066/C is considered as a skin sensitiser.
- Executive summary:
A study was performed to assess the allergenic potential of FAT 40066/C in albino guinea pigs according to OECD guideline 406. Ten animals (5 males, 5 females) were used as control group and 20 animals (10 males, 10 females) were used as test group. In pretest with 5 % concentration of test substance did not induce erythema reactions. In main test, on Day 0, three intradermal injections (5 % and 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, the application site of all animals was pretreated with 10 % sodium-laurylsul fate (open application) 24 hours prior to the epidermal induction application. In the test group 50 % FAT 40066/C was incorporated in Vaseline (w/w) 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. While the test and control group animals were challenged with 50 % FAT 40066/C in Vaseline (w/w) and on the other flank with the vehicle alone (patch 2x2 cm; approx. 0.2 g per patch; occluded administration for 24 hours). Under the experimental conditions employed, 100 % of the animals of the test group showed skin reactions (erythema and edema) 24 and 48 hours after removing the dressings. So, based on the study results, FAT 40066/C is considered as Skin sensitiser.
Reference
Body weights were not affected by treatment. Under the experimental conditions employed, 100 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Therefore, FAT 40066/C is classified as an extreme sensitiser in albino guinea pigs.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A key study was performed to assess the allergenic potential of FAT 40066/C in albino guinea pigs. The Maximization-Test protocol of B. Magnusson and A.M. Kligman (1970) was used. Ten animals (5 males, 5 females) were used as control group and 20 animals (10 males, 10 females) were used as test group. Under the experimental conditions employed, 100 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. According to the maximisation grading of Magnusson and Kligman FAT 40066/C showed an extreme grade of skin sensitising (contact allergenic) potential in albino guinea pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the findings in the skin sensitisation study, the test substance should be classified as Skin Sensitiser according to 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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