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EC number: 222-530-3 | CAS number: 3520-72-7
- 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
Skin sensitisation:
pigment orange 13 (nano form): not sensitising (OECD 429)
Structure analogue pigment orange 34(nano form): not sensitising (OECD 406, 429)
Structure analogue pigment red 38 (nano form): not sensitising (OECD 429)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From19 Oct 2005 to 8 Nov 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 429), GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, Horst, The Netherlands
- Age at study initiation: 6-8 weeks
- Weight prior to treatment: 20.1 +/- 1.2 g (mean +/- SD)
- Housing: individually in Macrolon cages
- Diet (ad libitum): pelleted standard diet (Harlan Winkelmann, Borchen, Germany)
- Water (ad libitum): tap water
- Acclimation period: yes, but duration not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- methyl ethyl ketone
- Concentration:
- 0, 2.5, 5 and 10% in vehicle
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
To determine the most suitable vehicle a pre-test was performed using the vehicles listed in OECD Guidline 429. Based on the results of this pre-test methyl ethyl ketone was selected as vehicle. To determine the highest non-irritant and technically applicable test item concentration, a pretest was performed in two mice with concentrations of 1.25, 2.5, 5 and 10% in methyl ethyl ketone. The top dose is the highest technically achievable concentration. Due to the intense orange colour of the test item local irritation reactions such as ear redness could not be examined.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an
incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as
indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although
allowance must be made (especially at high topical concentrations) for either local
toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Application volume 25 µl, applied on the dorsal surface of each ear lobe, spread over the entire dorals surface, once daily for three consecutive days - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- EC3: 22.2%
- Parameter:
- SI
- Value:
- 1.12
- Test group / Remarks:
- 2.5%
- Remarks on result:
- other: no indication of skin sensitisation based on in vivo test
- Parameter:
- SI
- Value:
- 1.14
- Test group / Remarks:
- 5%
- Remarks on result:
- other: no indication of skin sensitisation based on in vivo test
- Parameter:
- SI
- Value:
- 1.33
- Test group / Remarks:
- 10%
- Remarks on result:
- other: no indication of skin sensitisation based on in vivo test
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 2 750.32
- Test group / Remarks:
- 2.5%
- Remarks on result:
- other: no indication of skin sensitisation based on in vivo test
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 2 795.81
- Test group / Remarks:
- 5%
- Remarks on result:
- other: no indication of skin sensitisation based on in vivo test
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 3 267.7
- Test group / Remarks:
- 10%
- Remarks on result:
- other: no indication of skin sensitisation based on in vivo test
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test item was not senitising in the LLNA test
- Executive summary:
In the study the test item suspended in methyl ethyl ketone was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed according to guideline OECD 429, using test item concentrations of 2.5, 5 and 10%. No systemic findings were observed during the study period. Due to the intense orange colour of the test item local irritation reactions such as ear redness could not be examined. In this study Stimulation Indices (S.I.) of 1.12, 1.14 and 1.33 were determined with the test item at concentrations of 2.5, 5 and 10% (w/v) in methyl ethyl ketone, respectively. The test item was not a skin sensitiser in this assay.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 20 Aug 1991 to 20 Sep 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 406), GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- reduced number of animals (sufficient, if unambiguous result)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed before the adoption of OECD 429 LLNA in 2002.
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF Zucht
- Weight at study initiation: 295-352 g
- Housing: groups of 5 animals
- Diet (ad libitum): Altromin §112 Haltungsdiät für Meerschweinchen, Altromin GmbH, Lage/Lippe, Germany
- Water (ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Remarks:
- for epicutaneous treatment
- Concentration / amount:
- 1% (intradermal induction), 25% (epicutaneous induction), 1% (challenge)
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Remarks:
- for epicutaneous treatment
- Concentration / amount:
- 1% (intradermal induction), 25% (epicutaneous induction), 1% (challenge)
- No. of animals per dose:
- 6 for determination of the primary non-irritating concentration
3 for determination of the tolerance of the intradermal injections
10 for treated group
5 for control group
5 for accompanying group - Details on study design:
- RANGE FINDING TESTS:
The primary non-irritating concentration was determined in a pre-test in concentrations of 1, 5 and 25% test item in petrolatum, applied to the shaved left flanks of 2 animals each (0,5 g, 2 x 2 cm, occlusive, 24 h). 24 h after removal of the patch the treated areas were examined for erythema and edema.
The tolerance of the intradermal injections was tested with two injections of 0,1 ml of 0.2, 1.0 and 5.0% test item in paraffin. The injection sites (sites 1, 2 and 3) were all within a dorsal area measuring 2 x 4 cm in the vicinity of the shoulders.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two intradermal injections per animal, one epicutaneous treatment
- Exposure period: 48 h occlusive for dermal exposure
- Test groups: 10 females
Intradermal Treatment: The injection sites (site 1, 2 and 3) were all within a shaved dorsal area of 2 x 4 cm. The injection sites were left uncovered. Two intradermal injections of 0.1 ml per animal of the following preparations were applied (day 1 of study): site 1: 50% FCA, site 2: 1% test item in paraffin, site 3: test item in 50% FCA
Epicutaneous treatment: An amount of 0.5 g of the test item preparation (25% test substance in petrolatum) was administered to a 2 x 4 cm cellulose patch. This patch covered the area where the intradermal injection had been placed. The administration area was then kept under an occlusive bandage covered with an impermeable film and an elastic bandage for 48 hours.
- Control group and accompanying group: 5 females each
Controls received the same treatment with: intradermal site 1: 50% FCA ( Freund's Complete Adjuvants); site 2: paraffin; site 3: 50% FCA;
epicutaneous: petrolatum
- Site: dorsal, in vicinity of the shoulders
- Frequency of applications: day 1: intradermal treatment, day 8: epicutaneous treament
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: day 22 of study
- Exposure period: 24 h, occlusive
- Test groups: An amount of 0.5 g of the test item preparation was administered to a 2 x 2 cm cellulose patch.
- Site: left flank
- Concentrations: 1% in petrolatum (test and control group)
- Evaluation (hr after challenge): 24 and 48 h after removal of the patch
The accompanying group was challenged in the same way as the test group, but on days 15-18 of the study
OTHER:
Evaluation of effects: The decisive criterion for evaluation of the sensitizing properties of a test substance is the number of sensitized test animals, not the intensity of the dermal reaction. The substance is considered to be sensitizing if 30 % or more of the animals in the treatment group definitely showed a positive skin reaction and at the same time no irritant effects have emerged in the control group.
Scoring system for dermal reactions: according to guideline EU B.6 and OECD 406 - Positive control substance(s):
- not specified
- Remarks:
- According to guideline, a periodic test with a positive control substance is necessary. These data are not stated in study report, but also not mentioned under "deviations from guidelines"
- Positive control results:
- not stated
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: accompanying group
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: accompanying group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- other: accompanying group
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: other: accompanying group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
- Conclusions:
- Under the conditions of this guinea pig maximisation test, the test substance was not sensitising.
- Executive summary:
Skin sensitization of the test item was performed in 15 female guinea pigs (10 test group, 5 control group) according to the method of Magnusson & Kligman according to guidelines EU B.6 and OECD 406. Intradermal induction was performed with 1% test item in paraffin, dermal induction with 25% test item in petrolatum. The challenge treatment was conducted with 1% test item in petrolatum. Under the conditions of this guinea pig maximisation test, the test substance was not sensitising.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 6 Nov 2007 to 21 Nov 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 429), GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, Horst, The Netherlands
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 18.5-21.6 g
- Housing: individually in Macrolon cages
- Diet (ad libitum): pelleted standard diet (Harlan Winkelmann, Borchen, Germany)
- Water (ad libitum): tap water
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- other: ethanol/water (70/30)
- Concentration:
- 0, 5, 10, 20%
- No. of animals per dose:
- 4 females
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: highest technically achievable concentration: 20% solution in ethanol/water (70/30)
- Irritation: 2.5 to 20%, no signs of irritation or systemic toxicity at 20% concentration
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an
incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as
indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although
allowance must be made (especially at high topical concentrations) for either local
toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Application volume 25 µl, applied on the dorsal surface of each ear lobe, spread over the entire dorals surface, once daily for three consecutive days - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- not required
- Positive control results:
- EC3: 9.9%
- Parameter:
- SI
- Value:
- 0.92
- Test group / Remarks:
- 5%
- Remarks on result:
- other: no indication of skin sensitisation based on the in vivo test
- Parameter:
- SI
- Value:
- 1.59
- Test group / Remarks:
- 10%
- Remarks on result:
- other: no indication of skin sensitisation based on the in vivo test
- Parameter:
- SI
- Value:
- 1.54
- Test group / Remarks:
- 20%
- Remarks on result:
- other: no indication of skin sensitisation based on the in vivo test
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 4 080
- Test group / Remarks:
- 5%
- Remarks on result:
- other: no indication of skin sensitisation based on the in vivo test
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 7 061
- Test group / Remarks:
- 10%
- Remarks on result:
- other: no indication of skin sensitisation based on the in vivo test
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 6 821
- Test group / Remarks:
- 15%
- Remarks on result:
- other: no indication of skin sensitisation based on the in vivo test
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test item was not senitising in the LLNA test
- Executive summary:
In the study the test item (20% in ethanol/water 70/30) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed according to guideline OECD 429, using test item concentrations of 5, 10 and 20%. No systemic findings were observed during the study period. Due to the intense colour of the test item local irritation reactions such as ear redness could not be examined. In this study Stimulation Indices (S.I.) of 0.92, 1.59 and 1.54 were determined with the test item at concentrations of 5, 10 and 20% in ethanol/water 70/30, respectively. The test item was not a skin sensitiser in this assay.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 15 Jun 2005 to 21 Jun 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD 429), GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, Horst, The Netherlands
- Age at study initiation: 8-12 weeks
- Weight prior to treatment: 19.6 +/- 1.3 g (mean +/- SD)
- Housing: individually in Macrolon cages
- Diet (ad libitum): pelleted standard diet (Harlan Winkelmann, Borchen, Germany)
- Water (ad libitum): tap water
- Acclimation period: yes, but duration not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-80
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0, 6.25, 12.5 and 25% in vehicle (w/v)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: maximum applicable test concentration: 25%
- Irritation: 3.25 to 25% in DMSO
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response:
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an
incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as
indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although
allowance must be made (especially at high topical concentrations) for either local
toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
Application volume 25 µl, applied on the dorsal surface of each ear lobe, spread over the entire dorals surface, once daily for three consecutive days - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- ANOVA (Dunnett-Test)
- Positive control results:
- EC3: 8.9%
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 6.25%
- Remarks on result:
- other: no indication of skin sensitisation based on the assay
- Parameter:
- SI
- Value:
- 1.7
- Test group / Remarks:
- 12.5%
- Remarks on result:
- other: no indication of skin sensitisation based on the assay
- Parameter:
- SI
- Value:
- 2.4
- Test group / Remarks:
- 25%
- Remarks on result:
- other: no indication of skin sensitisation based on the assay
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 1 015.7
- Test group / Remarks:
- 6.25%
- Remarks on result:
- other: no indication of skin sensitisation based on the assay
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 1 252.7
- Test group / Remarks:
- 12.5%
- Remarks on result:
- other: no indication of skin sensitisation based on the assay
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 1 797.1
- Test group / Remarks:
- 25%
- Remarks on result:
- other: no indication of skin sensitisation based on the assay
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test item was not senitising in the LLNA test
- Executive summary:
In the study the test item suspended in DMSO was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed according to guideline OECD 429, using test item concentrations of 6.25, 12.5 and 25% (w/v). No systemic findings were observed during the study period. Due to the intense red colour of the test item local irritation reactions such as ear redness could not be examined. In this study Stimulation Indices (S.I.) of 1.3, 1.7 and 2.4 were determined with the test item at concentrations of 6.25, 12.5 and 25% in DMSO, respectively. The test item was not a skin sensitiser in this assay.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).
4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13). - Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- not stated
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: accompanying group
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: accompanying group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- other: accompanying group
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: other: accompanying group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no effects.
- Conclusions:
- Under the conditions of this guinea pig maximisation test, the test substance was not sensitising.
- Executive summary:
Skin sensitization of the test item was performed in 15 female guinea pigs (10 test group, 5 control group) according to the method of Magnusson & Kligman according to guidelines EU B.6 and OECD 406. Intradermal induction was performed with 1% test item in paraffin, dermal induction with 25% test item in petrolatum. The challenge treatment was conducted with 1% test item in petrolatum. Under the conditions of this guinea pig maximisation test, the test substance was not sensitising.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).
4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13). - Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- EC3: 8.9%
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 6.25%
- Remarks on result:
- other: no indication of skin sensitisation based on the assay
- Parameter:
- SI
- Value:
- 1.7
- Test group / Remarks:
- 12.5%
- Remarks on result:
- other: no indication of skin sensitisation based on the assay
- Parameter:
- SI
- Value:
- 2.4
- Test group / Remarks:
- 25%
- Remarks on result:
- other: no indication of skin sensitisation based on the assay
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 1 015.7
- Test group / Remarks:
- 6.25%
- Remarks on result:
- other: no indication of skin sensitisation based on the assay
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 1 252.7
- Test group / Remarks:
- 12.5%
- Remarks on result:
- other: no indication of skin sensitisation based on the assay
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 1 797.1
- Test group / Remarks:
- 25%
- Remarks on result:
- other: no indication of skin sensitisation based on the assay
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test item was not senitising in the LLNA test
- Executive summary:
In the study the test item suspended in DMSO was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed according to guideline OECD 429, using test item concentrations of 6.25, 12.5 and 25% (w/v). No systemic findings were observed during the study period. Due to the intense red colour of the test item local irritation reactions such as ear redness could not be examined. In this study Stimulation Indices (S.I.) of 1.3, 1.7 and 2.4 were determined with the test item at concentrations of 6.25, 12.5 and 25% in DMSO, respectively. The test item was not a skin sensitiser in this assay.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
[Please provide information for all of the points below. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to attached read across justification document (Chapter 13).
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to attached read across document (Chapter 13).
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to attached read across justification document (Chapter 13).
4. DATA MATRIX
Please refer to attached read across justification document (Chapter 13). - Reason / purpose for cross-reference:
- read-across source
- Positive control results:
- EC3: 9.9%
- Parameter:
- SI
- Value:
- 0.92
- Test group / Remarks:
- 5%
- Remarks on result:
- other: no indication of skin sensitisation based on the in vivo test
- Parameter:
- SI
- Value:
- 1.59
- Test group / Remarks:
- 10%
- Remarks on result:
- other: no indication of skin sensitisation based on the in vivo test
- Parameter:
- SI
- Value:
- 1.54
- Test group / Remarks:
- 20%
- Remarks on result:
- other: no indication of skin sensitisation based on the in vivo test
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 4 080
- Test group / Remarks:
- 5%
- Remarks on result:
- other: no indication of skin sensitisation based on the in vivo test
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 7 061
- Test group / Remarks:
- 10%
- Remarks on result:
- other: no indication of skin sensitisation based on the in vivo test
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- 6 821
- Test group / Remarks:
- 15%
- Remarks on result:
- other: no indication of skin sensitisation based on the in vivo test
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test item was not senitising in the LLNA test
- Executive summary:
In the study the test item (20% in ethanol/water 70/30) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed according to guideline OECD 429, using test item concentrations of 5, 10 and 20%. No systemic findings were observed during the study period. Due to the intense colour of the test item local irritation reactions such as ear redness could not be examined. In this study Stimulation Indices (S.I.) of 0.92, 1.59 and 1.54 were determined with the test item at concentrations of 5, 10 and 20% in ethanol/water 70/30, respectively. The test item was not a skin sensitiser in this assay.
Referenceopen allclose all
Due to the intense orange colour of the test item local irritation reactions such as ear redness could not be examined.
The EC3 value could not be calculated, since all SI were < 3.
Due to the intense colour of the test item local irritation reactions such as ear redness could not be examined.
The EC3 value could not be calculated, since all SI were < 3.
Due to the intense red colour of the test item local irritation reactions such as ear redness could not be examined.
The EC3 value could not be calculated, since all SI were < 3.
Due to the intense red colour of the test item local irritation reactions such as ear redness could not be examined.
The EC3 value could not be calculated, since all SI were < 3.
Due to the intense colour of the test item local irritation reactions such as ear redness could not be examined.
The EC3 value could not be calculated, since all SI were < 3.
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
No classification
Testing for sensitizing properties of the registration substance and sturcure analogues was performed according to the method of MAGNUSSON & KLIGMAN and LLNA.The challenge treatment caused no skin reaction.Based on the results of this study the test item showed no evidence for sensitizing properties.
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