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EC number: 278-174-4 | CAS number: 75284-35-4
- 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
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- Explosiveness
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
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- 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
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- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
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- 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
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- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
FAT 11127/C is considered to have not shown skin-sensitizing potential when tested in the Buehler assay.
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:
- other information
- Study period:
- From February 11, 1994 to August 4, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study terminated owing to animal welfare reasons
- 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.
- Specific details on test material used for the study:
- Test item : FAT 11127/C
Appearance : Dark blue powder. - Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Route:
- intradermal
- Vehicle:
- other: NaCl (0.9 %)
- Concentration / amount:
- 5 % suspension
- Day(s)/duration:
- 7 Days
- No. of animals per dose:
- 3 animals were used
- Details on study design:
- INDUCTION EXPOSURE
- No. of exposures: 1
- Test groups: 1
- Site: intradermal
- Frequency of applications: Once
- Concentrations: 5 % suspension of FAT 11127/C in NaCl (0.9%) - Positive control substance(s):
- no
- Remarks on result:
- not measured/tested
- Interpretation of results:
- study cannot be used for classification
- Executive summary:
FAT 11127/C was to be evaluated for Skin sensitization potential according to Guinea pig Maximization test as described in OECD Guideline 406.
For the intradermal induction application at the start of the study, a 5 % suspension of FAT 11127/C in NaCl (0.9 %) was used. After this application, a moderate skin reaction was observed, as had previously been seen in a pretest performed in two animals. However, within one week of the intradermal induction, the skin of the neck region and therefore limbs became bluish and on day 9 severe ulceration was observed in most animals of the test group. One male of the test group died on day 8.
On day 9, the Study Director decided to terminate the study for animal welfare reasons.
Conclusion
Intradermal injection of FAT 11127/C resulted in severe ulcerative effects in this test.
A pretest with epidermal application of FAT 11127/C showed only mild skin reactions. Therefore, a Buehler test is recommended instead of the Maximisation test.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 August, 1994 to 8 September, 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:
- Buehler 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:
- Test article: FAT 11127/C
Batch No.: 9309001
Purity: ca. 80 %
Physical properties: solid
Storage conditions: room temperature
Expiry date: June 1999 - 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: 291 to 369 g
- Housing: The animals were housed individually in Macrolon cages (Type 3),
- Diet: The animals received ad libitum standard guinea pig pellets - NAFAG No. 845, Gossau SG.
- Water: ad libitum
- Acclimation period: 7 days.
- Indication of any skin lesions: No
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 30 to 70 %
- Photoperiod: 12 hours light cycle day. - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled water
- Concentration / amount:
- 50 %
- Day(s)/duration:
- Weeks 1 to 3
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- distilled water
- Concentration / amount:
- 30 %
- Day(s)/duration:
- Week 5
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- - 10 male and 10 female guinea pigs in test group.
- 5 males and 5 females in the control group. - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three epidermal occlusive test application during weeks 1 to 3
- Exposure period: 3 weeks
- Test groups: Epidermal induction (weeks 1 to 3)
- Concentration of test article: 50 % in distilled water
- Control group: Distilled water
- Site: Epidermal
- Frequency of applications: once a week
- Duration: 6 hours
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Exposure period: 6 Hours
- Concentration of test article: 30 % in distilled water
- Control group: Distilled water
- Site: Epidermal
- Evaluation: Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to a modified Draize scoring scale. - Challenge controls:
- Distilled water
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole puriss (Test No. 930025)
- Positive control results:
- After 24 hrs : 4/20 animals showed a positive result.
After 48 hrs : 6/20 animals showed a positive result. - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % for induction and 30 % for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % for induction and 30 % for challenge
- 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:
- negative control
- 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
- 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:
- 2-Mercaptobenzothiazole puriss. induction 75 % , challenge 20 %
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 2-Mercaptobenzothiazole puriss. induction 75 % , challenge 20 %
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 11127/C did not show skin-sensitizing potential in albino guinea pigs.
- Executive summary:
The test substance FAT 11127/C was tested for skin sensitization potential according to Buehler test as described in OECD Guideline 406. The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, respectively.
Epidermal induction consisted of three epidermal occlusive substance applications on the same skin site for 6 hours each (weeks 1 to 3) at concentration of 50 % test substance in distilled water, a rest period of 13 to 15 days, followed by a challenge period (at test substance concentration of 30 % in distilled water) with epidermal occlusive application of the test article for 6 hours (week 5).
No animal of the test group was sensitized by FAT 11127/C under the experimental conditions employed. Hence, FAT 11127/C is considered to have not shown skin-sensitizing potential in albino guinea pigs.
Referenceopen allclose all
FAT 11127/C was to be evaluated for Skin sensitization potential according to Guinea pig Maximization test as described in OECD Guideline 406. For the intradermal induction application at the start of the study, a 5 % suspension of FAT 11127/C in NaCl (0.9 %) was used. After this application, a moderate skin reaction was observed, as had previously been seen in a pretest performed in two animals. However, within one week of the intradermal induction, the skin of the neck region and therefore limbs became bluish and on day 9 severe ulceration was observed in most animals of the test group. One male of the test group died on day 8. On day 9, the Study Director decided to terminate the study for animal welfare reasons. Two animals were sent to histopathology. Hence, it was concluded that intradermal injection of FAT 11127/C resulted in severe ulcerative effects in this test. A pretest with epidermal application of FAT 11127/C showed only mild skin reactions. Therefore, a Buehler test is recommended instead of the Maximisation test.
Pathology
The results of the gross pathological and histopathological examination of the skin and axillary lymph node in the two animals sacrificed in moribund condition on study day 9 are presented below.
Macroscopical findings:Ulceration and a scab formation of the skin of animals sacrificed.
Additionally, in the female no. 96, the axillary lymph node was reported as enlarged. The spleen was reported as large in both animals, but, upon request of the sponsor, no histopathological examination was performed.
Microscopical findings:
The skin was found to be moderately ulcerated in both animals. Furthermore, the subcutaneous tissue revealed a marked abscess formation, accompanied by a moderate chronic inflammation of the dermis and subcutaneous tissue in both guinea pigs and a dermal necrosis in the male no. 89. The epidermis was moderately acanthotic and showed a minimal to moderate paraketosis in both animals, in the female no. 96 also associated with a moderate epidermal hyperkeratosis.
Axillary lymph node:
The axillary lymph nodes were found to be activated and were given the diagnosis of a 'chronic reactive hyperplasia' which was minimal in male no. 89 and moderate in female no. 96.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
FAT 11127/C was to be evaluated for skin sensitization potential according to Guinea pig Maximization test (OECD Guideline 406). However, intradermal injections of FAT 11127/C resulted in severe ulcerative effects in this test. Hence, the study was terminated. A pretest with epidermal application of FAT 11127/C showed only mild skin reactions. Therefore, a Buehler test was carried out. In this Buehler test, epidermal induction consisted of three epidermal occlusive applications on the same skin site for 6 hours each (weeks 1 to 3) at concentration of 50 % test substance in distilled water, a rest period of 13 to 15 days, followed by a challenge period (at test substance concentration of 30 % in distilled water) with epidermal occlusive application of the test article for 6 hours (week 5). No animal of the test group was sensitized by FAT 11127/C under the experimental conditions employed. Hence, FAT 11127/C is considered to have not shown skin-sensitizing potential in albino guinea pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
FAT 11127/C is considered to have not shown skin-sensitizing potential when tested in the Buehler assay, hence it does not need to be classified for sensitisation as per the criteria of 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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