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EC number: 276-292-0 | CAS number: 72017-66-4
- 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
A guinea pig maximisation test was performed to determine the sensitization potential of FAT 20202/E according to OECD Guideline 406 and EU Method B.6 (Skin Sensitisation). Ten females were used as control group and 20 females were used as test group. FAT 20202/E was used at 5 % for intradermal induction, while it was used at 10 % for epidermal induction. The highest non-irritating test article concentration used for both challenge applications was 1 %. In addition, the test article at 0.5 % was applied. No positive reactions were observed in the animals during the challenge phase. Only 1 animal out of 19 had positive reaction during the rechallenge at 1 % at the 24 hour reading, which was found to have reversed by 48-hour reading. No positive reaction was seen at 0.5 % during the rechallenge. Based on the findings of the study, FAT 20202/E is therefore classified as a non- sensitiser 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:
- 04 October, 1993 to 28 February, 1994.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- A second epidermal pretest was performed due to equivocal findings observed after the first epidermal pretest. The animals were weighed at their delivery
and at the end of the study. The allocation, age, number of animals were adapted to the additional animals. - Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Two test article concentrations were applied in the first and second challenge.
- Principles of method if other than guideline:
- None
- 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:
- Identification: FAT 20202/E
Description: light red, solid
Batch Number: Op. 161
Purity/formation: 70.1 % active ingredients
Stability of test article: stable;expiration date: March, 1998
Stability of test article dilution: unknown in water, in vaselinum album and FCA:physiological saline (1:1); excluded from the Statement of Compliance
Storage Conditions: at room temperature (approx. 20 °C), away from direct sunlight
Safety precautions: Gloves, goggles and face mask were obligatory to assure personnel health and safety. - Species:
- guinea pig
- Strain:
- other: Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wölferstrasse 4, CH-4414 Füllinsdorf/Switzerland
- Females (if applicable) nulliparous and non-pregnant: 30 females / 10 females, nulliparous and nonpregnant
- Housing: Individually in Makrol on type-3 cages (size: 22x37x15 cm) with standard softwood bedding
- Age at study initiation: 6 - 8 weeks except for the animals of the epidermal pretest II: 5-6 weeks
- Weight at study initiation: - at acclimatization start Control and Test Group 294 - 386 g
Intradermal pretest and epidermal pretest I 307 - 380 g
- at test day 3 Delivery of the epidermal pretest II: 274 - 338 g
- Diet: Pelleted standard Kliba 342, Batch nos. 79/93 (from acclimatization start to October 29, 1993) and 80/93 (from October 30, 1993 to November 12, 1993) guinea pig breeding/maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum.
- Water: Community tap water from Füllinsdorf, ad libitum. Once weekly additional supply of ascorbic acid (1 g/1) via the drinking water.
- Acclimation period: One week for the control and test group under test conditions after health examination. No acclimatization period for the animals of the pretest. Only animals without any visual signs of illness were used for the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 40-70 %,
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light (approx. 100 lux) /12 hours dark, music during the light period.
IN LIFE PHASE: Start date: 4th October 1993: End date: 12th November 1993 - Route:
- intradermal
- Vehicle:
- other: bidistilled water
- Concentration / amount:
- 5 %
- Day(s)/duration:
- Test Day 01
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaselinum album
- Concentration / amount:
- 10 % in vaselinum album
- Day(s)/duration:
- Test Day 08
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaselinum album
- Concentration / amount:
- 1% in vaselinum album (left cranial flank), a lower concentration of 0.5% in vaselinum album (left caudal flank) and vaselinum album only (right flank) using the same method as for the epidermal application.
- Day(s)/duration:
- Test Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaselinum album
- Concentration / amount:
- 1% in vaselinum album (left cranial flank), a lower concentration of 0.5% in vaselinum album (left caudal flank) and vaselinum album only (right flank) using the same method as for the epidermal application.
- Day(s)/duration:
- Test Day 29
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 1. Control Group 10
2. Test Group 20
3. Intradermal Pretest 02
4. Epidermal Pretest I 04
5. Epidermal Pretest II 04 - Details on study design:
- RANGE FINDING TESTS:
PRETEST / performed during the acclimatization period. The objective of this investigation was to identify a maximally tolerated concentration of the test article suitable for the induction phase of the main study. In addition, a suitable non-irritant concentration of the test article, by the topical route of administration, was identified for the challenge application.
The procedure employed for these investigations was as follows:
INTRADERMAL INJECTIONS:
Intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea-pigs at concentrations of 5, 3 and 1 % of the test article in bi-distilled water. The resulting dermal reactions were assessed 24 hours later. For intradermal induction application a 5 % test article dilution was selected.
EPIDERMAL APPLICATION I:
Both flanks of each of 4 guinea pigs were clipped and shaved just prior to the application. Thereafter patches of filter paper ( 2 x 2 cm) were saturated with
concentrations of 25 %, 15 %, 10 % and 5 % of the test article in vaselinum album and applied to the clipped and shaved flanks. The patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. This procedure ensured the intensive contact of the test article. 21 hours after removing of the dressing the application site was depilated with an approved depilatory cream (VEET Cream, Reckitt & Colmann AG, CH-4005 Basel) to clean the application site from staining produced by the test article, so that possible erythema reactions were clearly visible at that time. The depilatory was placed on the patch sites and surrounding areas, and left on for 3-5 minutes. It was then thoroughly washed off with a stream of warm, running water. The animals were then dried with a disposable towel, and returned to their cages. The dressings were removed after an exposure period of 24 hours. The reaction sites were assessed 24 (i.e. 3 hours after depilation) and 48 hours after removal of the bandage for erythema and oedema on a numerical basis according to Draize described above.
EPIDERMAL APPLICATION II:
A second epidermal pretest was performed because the highest non-irritating concentration could not be determined after the first epidermal pretest. The same way as described previously was performed. Only the test article concentrations were changed and the test article at 5, 1, 0.5 and 0.1% in vaselinum album was applied with four other guinea pigs. For the epidermal induction a 10% and for the challenge procedure a 1 % and 0.5 % test article solution was applied.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: not applicable
- Test groups: 1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline.
2) The test article, diluted to 5 % with bi-distilled water
3) The 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: area of dorsal skin from the scapular region
- Frequency of applications: Once
- Concentrations: 0.1 ml/site
B. INDUCTION EXPOSURE (epidermal)
- No. of exposure: 1
- Exposure period: 4 hours
- Site: scapular area (approximately 6 x 8 cm)
- Frequency of applications: Once
- Concentration: 10 % in vaselinum album
C. CHALLENGE EXPOSURE 01
- No. of exposures: 01
- Day(s) of challenge: Tets day 22
- Test groups: 1 % in vaselinum album (left cranial flank), a lower concentration of 0.5 % in vaselinum album (left caudal flank) and vaselinum album only (right flank)
- Site: left cranial flank and left caudal flank
- Concentrations: 1 and 0.5 %
- Evaluation (hr after challenge): 24 and 48 hours after the removal of the dressing the application sites were assessed for erythema and oedema using the numerical scoring system according to Draize.
D. CHALLENGE EXPOSURE 02
- No. of exposures: 01
- Day(s) of challenge: Tets day 29
- Test groups: 1% in vaselinum album (left cranial flank), a lower concentration of 0.5 % in vaselinum album (left caudal flank) and vaselinum album only (right flank)
- Site: left cranial flank and left caudal flank
- Concentrations: 1 and 0.5 %
- Evaluation (hr after challenge): 24 and 48 hours after the removal of the dressing the application sites were assessed for erythema and oedema using the numerical scoring system according to Draize. - Challenge controls:
- None
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazol
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 % in vaselinum album (left cranial flank), 0.5% in vaselinum album (left cuadal flank) and Vaselinum album (right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: first challenge
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 % in vaselinum album (left cranial flank), 0.5% in vaselinum album (left cuadal flank) and Vaselinum album (right flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: first challenge
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% in vaselinum album (left cranial flank) and Vaselinum album (right flank) using the same method as for the epidermal application.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: first challenge
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% in vaselinum album (left cranial flank) and Vaselinum album (right flank) using the same method as for the epidermal application.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: first challenge
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5% in vaselinum album (left cuadal flank) and Vaselinum album (right flank) using the same method as for the epidermal application.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: first challenge
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5% in vaselinum album (left cuadal flank) and Vaselinum album (right flank) using the same method as for the epidermal application.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: first challenge
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Vaselinum album (left flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vaselinum album (left flank)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% in vaselinum album (right cranial flank), Vaselinum album (left flank) using the same method as for the epidermal application.
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% in vaselinum album (right cranial flank), Vaselinum album (left flank) using the same method as for the epidermal application.
- No. with + reactions:
- 0
- Total no. in group:
- 18
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5% in vaselinum album (right caudal flank), Vaselinum album (left flank) using the same method as for the epidermal application.
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5% in vaselinum album (right caudal flank), Vaselinum album (left flank) using the same method as for the epidermal application.
- No. with + reactions:
- 0
- Total no. in group:
- 18
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- The intradermal induction was performed with a dilution at 5% in acetone. For the induction period and challenge procedure a 25% dilution of 2-MERCAPTOBENZOTHIAZOL in acetone was used.
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20202/E is not a sensitiser.
- Executive summary:
A guinea pig maximisation test was performed to determine the sensitization potential of FAT 20202/E according to OECD Guideline 406 and EU Method B.6 (Skin Sensitisation). Ten females were used as control group and 20 females were used as test group. FAT 20202/E was used at 5 % for intradermal induction, while it was used at 10 % for epidermal induction. The highest non-irritating test article concentration used for both challenge applications was 1%. In addition the test article at 0.5 % was applied. No positive reactions were observed in the animals during the challenge phase. Only 1 animal out of 19 had positive reaction during the rechallenge at 1 % at the 24 hour reading, which was found to have reversed by 48 hour reading. No positive reaction was seen at 0.5 % during the rechallnge. Based on the findings of the study, FAT 20202/E is therefore, classified as a non-sensitiser in albino guinea pigs.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data from the GPMT study, Acid Red 407 does not warrant classification for skin sensitisation under the CLP (1272/2008) Regulation.
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