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EC number: 916-540-3 | CAS number: -
- 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
Not skin sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From May 30 to June 30, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- The read across approach is detailed into the document attached into the IUCLID section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted July 17, 1992
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study already available
- Species:
- guinea pig
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Test system: Ibm: GOHI; SPF-quality guinea pigs.
- Source: BRL, Biological Research Laboratories Ltd.
- Age at study initiation: 5 - 7 weeks.
- Weight at study initiation: 304 - 429 g; in pretest 331 - 400 g
- Housing: individually in Makrol on type-3 cages with autoclaved standard softwood bedding.
- Diet: pelleted standard Kliba 342, Batch no. 62/94 (at delivery of the animals to 02-JUN-1994) and 63/94 (from 03-JUN-1994 to termination of test) 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/l) via the drinking water.
- Acclimation period: one week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pretest. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 - 25 °C
- Humidity: 56 - 82 %
- Air changes: air-conditioned with 10-15 air changes per hour.
- Photoperiod: 12 hours artificial fluorescent light (approx. 100 Lux) /12 hours dark.
- Other: music during the light period. - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25 %
- No. of animals per dose:
- Control Group 10 animals
Test Group 20 animals
Intracutaneous pretest 2 animals; epicutaneous pretest 4 animals - Details on study design:
- TEST ARTICLE PREPARATION
The test article and the vehicles were placed into a glass beaker on a tared Mettler PM 480 balance and weight/weight dilutions were prepared. Homogeneity of test article in bi-distilled water and FCA/ physiological saline (1/1) was reached using a magnetic stirrer and a spatula was used for the test article in vaselinum album. The preparations were made immediately prior to each dosing.
RANGE FINDING TESTS
- Intradermal injections: 0.1 ml/site
- Concentrations: 5, 3 and 1% of the test article in bi-distilled water.
- No of animals: 2
- Observation: the resulting dermal reactions were assessed 24 hours later.
- Epidermal application: 4 patches* of filter paper (2 x 2 cm) were saturated with the test article at A = 50 % (this concentration used was found to be the most qualified to assure an optimum technical application procedure), B = 25 %, C = 15 % and D = 10 % of the test article in vaselinum album and applied to the clipped and shaved flanks.
- Bendage: 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.
- No of animals: 4
- Exposure period: the dressings were removed after an exposure period of 24 hours.
- Observation: 21 hours after removing of the dressing the application site was depilated with an approved depilatory cream to clean the application site from staining produced by the test article, so that possible erythema reactions were clearly visible at that time.
- Observations: the reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema on a numerical basis according to Draize criteria.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injections / performed on test day 1
- Amount: 0.1 ml/site
- No. of exposures: three pairs of intradermal injections.
- Test groups: 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline; the test article, diluted to 5 % with bi-distilled water; 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 (v/v) mixture of Freund's Complete Adjuvant and physiological saline; bi-distilled water; 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:
Epidermal applications / performed on test day 8
- Application: a 2 x 4 cm patch of filter paper was saturated with the test article (50 % in vaselinum album) and placed over the injection sites of the test animals.
- Bendage: the patch was covered with aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape.
- Exposure period: the dressings were left in place for 48 hours.
- Observations: reaction sites were assessed for erythema and oedema 24 and 48 hours after removal of the dressing, using the numerical grading system according to Draize.
B. CHALLENGE EXPOSURE / performed on test day 22
- Days after induction: the test and control guinea-pigs were challenged two weeks after the epidermal induction application.
- Application: two patches ( 2 x 2 cm) of filter paper were saturated with the non-irritating concentration of 25 % (left flank) and the vehicle only (vaselinum album, applied to the right flank) using the same method as for the epidermal application.
- Exposure period: the dressing were left in place for 24 hours.
- Observations: 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.
INTERPRETATION
The results obtained from test animals following the challenge applications were compared with the results seen in control animals.
An allergic reaction was defined by visible reddening of the challenge site.
If the dermal reactions of test animals following the challenge were more marked and/or persistent than those of the control animals, the animals were considered to show evidence of contact hypersensitivity.
If the dermal reactions of test animals following the challenge were not clearly different from the reactions seen in the control group animals, the results for the test animals were considered "inconclusive".
The test animals were considered to show no evidence of contact hypersensitivity if the dermal reactions to the challenge application were identical to or less marked and/or persistent than the reactions observed in the control animals.
OBSERVATIONS
- Viability/Mortality: daily during the observation period.
- Clinical Signs (local/systemic): daily during the observation period.
- Skin reactions: at the times specified during the induction and challenge periods.
- Body Weights: at the beginning of the acclimatization period, at day one and at the termination of the test. - Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazol and 4-Aminobenzoic acid ethyl ester
- 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
- 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:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 %
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 2-mercaptobenzothiazol
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 %
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 4-Aminobenzoic acid ethyl ester
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- Not skin sensitising
- Executive summary:
To assess the allergenic potential of test item in albino guinea pigs, the Maximization-Test of B. Magnusson and A.M. Kligman (1969) was used. Ten males were used as control group and 20 males were used as test group. The highest non-irritating test article concentration used for challenge application was 25 % in vaselinum album.
In the study, 5 % of the animals of the test group were positive after treatment with a non-irritant test substance concentration of 25 % in vaselinum album. No positive reactions were observed in the control group.
The response of at least 30 % positive animals is considered positive; therefore the test article should be considered to be a non-sensitizer when described under the test conditions.
Conclusion
Not skin sensitising
Reference
MAIN TEST
SKIN EFFECTS AFTER INTRADERMAL INDUCTION PERFORMED ON TEST DAY 1
CONTROL GROUP
- Injection site 1 (1:1 (v/v) mixture of Freund's Complete Adjuvant [FCA] and physiological saline)
The area around the injection site was oedematous and erythematous from test day 2 to 6 and 2 to 5 respectively and then became necrotic from test day 7 to 11 followed by encrustation and exfoliation of encrustation up to test day 25 (termination of test).
- Injection site 2 (bi-distilled water)
The area around the injection site was oedematous and erythematous from test day 2 to 4.
- Injection site 3 (1:1 (w/w) mixture of bi-distilled water in a 1:1 (v/v) mixture of FCA and physiological saline)
The reactions observed were identical to those obtained at injection site 1 with the mixture of FCA and physiological saline.
As the animals were bandaged with the semi-occlusive dressing no observations of the skin were possible on test day 9.
TEST GROUP
- Injection site 1 (1:1 (v/v) mixture of Freund's Complete Adjuvant [FCA] and physiological saline)
The area around the injection site was oedematous and erythematous from test day 2 to 4 and and then became necrotic from test day 5 to 7 followed by encrustation and exfoliation of encrustation up to test day 25.
- Injection site 2 (5% dilution of test article in bi-distilled water)
The area around the injection site was oedematous and orange discolored from test day 2 to 4 and 2 to 6 respectively, necrotic from test day 5 to 7. Encrustation was observed from test day 8 to 15 followed by exfoliation of encrustation up to the termination of test.
- Injection site 3 {5% dilution of test article in a 1:1 (v/v) mixture of FCA and physiological saline)
The area around the injection site was oedematous and orange discolored from test day 2 to 4 and 2 to 6 respectively, necrotic from test day 5 to 7. Encrustation was observed from test day 8 to 11 followed by exfoliation of encrustation up to the termination of test. As the animals were bandaged with the semi-occlusive dressing no observations of the skin were possible on test day 9.
SKIN EFFECTS AFTER EPIDERMAL INDUCTION PERFORMED ON TEST DAY 8
CONTROL GROUP
No erythematous or oedematous reaction was observed in the animals treated with vaselinum album only.
TEST GROUP
As the test article stained the skin orange, it was not possible to determine whether erythema was present. However, no oedema was observed. Orange discolouration was noted from test day 10 to 24.
All the animals were pretreated with a 10 % SLS in paraffinum perliquidum.
SKIN EFFECTS AFTER THE CHALLENGE PERFORMED ON TEST DAY 22
CONTROL GROUP
No positive reactions were observed in the animals either when treated with vaselinum album alone or when treated with the test article at 25 % in vaselinum album.
Orange discolouration was noted from test day 23 (after removal of the dressing to 24 (prior to the depilation).
TEST GROUP
No positive reactions were observed in the animals treated with vaselinum album.
When treated with the test article at 25% in vaselinum album, one animal exhibited a very slight erythematous reaction at the 24-hour reading.
Orange discolouration was noted from test day 23 (after removal of the dressing to 24 (prior to the depilation).
VIABILITY / MORTALITY / MACROSCOPIC FINDINGS
As there were no deaths during the course of the treatment period no necropsies were performed.
CLINICAL SIGNS, SYSTEMIC
No symptoms of systemic toxicity were observed in the animals.
BODY WEIGHTS
The body weight of the animals was within the normal range of variability.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is no data about the skin sensitization potential of Acid Orange 127; therefore, the available data on structural analogous Similar Substance 02 has been taken into consideration. The read across approach can be considered as appropriate and suitable to assess the property under investigation (details about the approach are reported into the IUCLID section 13).
To assess the allergenic potential of Similar Substance 02 in albino guinea pigs, the Maximization-Test of B. Magnusson and A.M. Kligman (1969) was used. Ten males were used as control group and 20 males were used as test group. The highest non-irritating test article concentration used for challenge application was 25 % in vaselinum album. In the study, 5 % of the animals of the test group were positive after treatment with a non-irritant test substance concentration of 25 % in vaselinum album. No positive reactions were observed in the control group. The response of at least 30 % positive animals is considered positive; therefore the test article should be considered to be a non-sensitizer when described under the test conditions.
Justification for classification or non-classification
According to the CLP Regulation (EC) No 1272/2008, 3.4 respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact.
For a non-adjuvant Guinea pig test method a response of at least 15 % of the animals is considered positive.
Based on the available information, Acid Orange 127 can be considered as non skin sensitizer.
In conclusion, the substance does not meet the criteria to be classified as skin sensitizer, according to the CLP Regulation (EC) No 1272/2008.
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