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EC number: 277-955-7 | CAS number: 74664-50-9
- 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
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Endpoint summary
Administrative data
Description of key information
Not skin sensitising in Guinea pig maximisation test.
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 October 22, 1991 to January 14, 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The complete read across justification is detailed in section 13. Source study has reliability 1.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Guinae pig maximisation test was available.
- Species:
- guinea pig
- Strain:
- other: Himalayan spotted
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: control and test group (393 - 502 g), pretest (402-473 g)
- Housing: individually in Makrolon type-3 cages (size: 27 x 42 x 15 cm) with standard softwood bedding ("Lignocel")
- Diet: pelleted standard Kliba 342 (ad libitum)
- Water: tap water (ad libitum); once weekly additional supply of ascorbic acid (1 g/L via the drinking water)
- Acclimation period: one week under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity: 40-70 %
- Air changes: 10-15 per hr
- Photoperiod: 12/12 hrs dark/hrs light - Route:
- intradermal and epicutaneous
- Vehicle:
- other: physiol. saline (intradermal), vaselinum album (epidermal)
- Concentration / amount:
- 5 % in physiol. saline
25 % in vaselinum album - Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaselinum album
- Concentration / amount:
- 25 % in vaselinum album
- No. of animals per dose:
- Control group: 10
Test group: 20 - Details on study design:
- RANGE FINDING TEST
For the intracutaneous pretest, 2 females were used; for the epicutaneous pretest, 4 females were used.
A. Intradermal injections
- 5, 3 and 1 % of test substance in physiol. saline
- site: flank
- dermal reactions were assessed 24 hours later
B. Epidermal applications
- 25, 15, 10 and 5 % of test substance in vaselinum album
- site: flank
- exposure period: 24 hours
- examination was performed 24 and 48 hours after removal of the dressing
MAIN STUDY
A.1. INDUCTION EXPOSURE (intradermal): day 0
- No. of exposures: 3 pairs of intradermal injections (0.1 ml/site) were made
- Test groups: Freund's complete adjuvant 50:50 with physiol. saline, 5 % test substance in physiol. saline, 5 % test substance in a mixture of Freund's complete adjuvant and physiol. saline (50:50)
- Control group: Freund's complete adjuvant 50:50 with physiol. saline, physiol. saline, Freund's complete adjuvant 50:50 with physiol. saline
- Site: area of dorsal skin from the scapular region
- Frequency of applications: single injection
A.2. INDUCTION EXPOSURE (epidermal); day 8
- Test group: 25 % of the test substance in vaselinum album
- Control group: vaselinum album only
- Site: the injection sites of the test animals
- Duration: 48 hours
B. CHALLENGE EXPOSURE; 2 weeks after the epidermal induction application (day 22)
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups: left flank: 25 % test substance in vaselinum album, right flank: vaselinum album only
- Control group: treated in the same way as described at the test group
- Site: flank
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- yes
- Positive control substance(s):
- yes
- Remarks:
- formaldehyde
- Positive control results:
- 8 of 10 animals showed skin reactions 24 h and 48 h after removing the dressings.
- 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:
- negative control
- Dose level:
- 25%
- 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:
- 25%
- 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:
- test chemical
- Dose level:
- 0%
- 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:
- 0%
- 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:
- 25%
- 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:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Test substance was non sensitising in a Guinea pig maximisation test.
- Executive summary:
Method
Guinea pig maximisation test was carried out according to OECD guideline 406. In the pretest, test substance was applied by intradermal route at concentrations of 1, 3 and 5 % and by epidermal route at concentrations of 5, 10, 15 and 25 %. Main study was conducted with 10 females in the control group and 20 females in the test group. Intradermal induction was done at a concentration of 5 % in physiological saline; epidermal induction and epidermal challenge were done with a concentration of 25 % in vaselinum album. Observations were performed 24 and 48 hours after challenge. Formaldehyde was applied as positive control.
Results
Local signs were reported at the injection site in both control and test group, in terms of erythema, oedema and necrosis. Epidermal application resulted in staining of the exposed area. No signs of systemic toxicity were noted. Based on the lack of positive responses after challenge, test substance resulted as non sensitising.
Positive control gave 80 % of positive response 24 and 48 hours after challenge.
Reference
Viability/mortality: no death occurred during the study.
Clinical signs, local
Control group
Application area around the injection sites was found to show erythema and oedema from day 2 to 7; additionally around 2 of 3 injection sites necroses were observed from day 8 to 20; encrustation from day 19 to 21 and exfoliation from day 21 to 25 (termination of test). In addition staining was observed in the challenge application area from day 23 to 25.
Test group
Application area around one of the injection sites was found to show erythema and oedema from day 2 to 7. Application area around the other 2 injection sites showed oedema and staining from day 2 to 7. For the 3 injection sites necroses were observed from day 8 to 20; encrustation from day 19 to 21 and exfoliation from day 21 to 25. In addition epidermal induction and challenge application area showed staining from day 10 to 25 and 23 to 25 respectively.
On day 9 of test no observation could be performed because the animals were bandaged semi-occlusively.
Clinical signs, systemic
No systemic symptoms were observed in the animals.
Body weights
2 out of 10 control animals, 4 out of 20 test animals and both animals of the intradermal pretest lost weight during the acclimatization period. The body weight gain of the other animals was not affected during the entire study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
To assess the allergenic potential of the test substance (91% act. ingr.) in albino guinea pigs the maximization test of Magnusson and Kligman was used.
A pretest was performed to identify irritant test substance concentrations suitable for the induction phase of the main study. In addition, a suitable non-irritant concentration of test substance by the topical route of administration was identified for the challenge application. In the main study 10 females were used as control group and 20 females were used as test group. Animals in test group were treated with the following concentrations of test item:
- induction phase: 5 % intradermal on day 0 and 25% epidermal on day 8
- challenge phase: 25 % two weeks after epidermal induction application.
No skin reactions (erythema or oedema) were observed 24 and 48 hours after challenge. No signs of systemic toxicity were noted.
Formaldehyde was used as positive control, leading to 80 % positive results in the treated animals after epidermal challenge application.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), skin sensitizer is a substance that will lead to an allergic response following skin contact. In case of a Guinea pig maximisation test, a response of at least 30 % of the animals is considered as positive.
Under the experimental conditions employed, 0 % of animals of test group showed skin reactions 24 and 48 hours after removing the dressings.
In conclusion, the substance does not meet the criteria to be classified as skin sensitising, according to the CLP Regulation (EC 1272/2008).
Based on a read across approach, Direct Blue 273 is considered as non skin sensitising.
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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