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EC number: 205-447-7 | CAS number: 141-01-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Weight of evidence approach based on various test chemicals
- Justification for type of information:
- Weight of evidence approach based on various test chemicals
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (OECD, 1992), EC guideline B.6 (EC, 1996) and the US EPA Guideline OPPTS 870.2600 (US EPA, 2003).
- Principles of method if other than guideline:
- The guinea pig maximization test was performed according to OECD Test Guideline No. 406
- GLP compliance:
- not specified
- Remarks:
- data is from publication
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
- Species:
- guinea pig
- Strain:
- other: SPF-Hsd Poc: DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Female guinea pigs were purchased from Harlan Winkelmann (Borchen, Germany).
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified] : yes
- Microbiological status of animals, when known:
- Age at study initiation:
- Weight at study initiation: 300–500 g at the commencement of the study
- Housing: The guinea pigs were housed in groups in Terluran cages on Altromin saw fiber bedding or Lignocel bedding
- Diet (e.g. ad libitum): Altromin 3122 maintenance diet for guinea pigs or ssniff Ms-H, 4mm V2233-000 complete diet for guinea pigs, rich in crude fiber, totally-pathogen-free), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: The acclimatization period was at least five days.
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 degrees C,
- Humidity (%): 55 ± 10%
- Air changes (per hr): air change rate of at least 10 times/hour
- Photoperiod (hrs dark / hrs light): 12-h light/ dark cycle
- IN-LIFE DATES: From: To: - Route:
- intradermal
- Vehicle:
- cotton seed oil
- Concentration / amount:
- Intradermal = 5% test chemical in cottonseed oil
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- Epicuteanous = 0.5 g of 25% test chemical in vaseline
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 0.5 g of 10% test chemical in vaseline
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Each test was performed with 10 test and five control animals
- Details on study design:
- RANGE FINDING TESTS: A range finding for the test concentrations was performed in a preliminary experiment assessing the irritant effects of the test compounds after intradermal and
topical application.
MAIN STUDY
A. INDUCTION EXPOSURE - Intradermal exposure
- No. of exposures: single
- Exposure period:
- Test groups: 10
- Control group: 5
- Site:
- Frequency of applications: three pairs of injections of 0.1 ml each of the test compound i.e 5% test chemical in cottonseed oil ; the test compound in a 1:1 (v/v) mixture of FCA/physiological saline and a 1:1 (v/v) mixture of FCA/physiological saline without test compound.
- Duration: 24 hours
- Concentrations: three pairs of injections of 0.1 ml each of the test compound i.e 5% test chemical in cottonseed oil ; the test compound in a 1:1 (v/v) mixture of FCA/physiological saline and a 1:1 (v/v) mixture of FCA/physiological saline without test compound.
A. INDUCTION EXPOSURE - Intradermal exposure
- No. of exposures: single
- Exposure period: 48 hours
- Test groups: 10
- Control group: 5
- Site:
- Frequency of applications: single
- Duration: 48 hours
- Concentrations: 0.5 g of the 25% test chemical in vaseline
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Concentrations:
- Evaluation (hr after challenge): 48 hours and 72 hours
OTHER: - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10% test chemical in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity were observed for the test substances in any of the animals
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No signs of systemic toxicity were observed for the test chemical in any of the animals. The test chemical caused a grade 1 skin reaction in one animal of the treatment group. The skin reaction was observed 24 and 48 h after patch removal. As from the visible inspection of the treated skin site, a sensitizing reaction cannot be differentiated from a skin irritation reaction, a re-challenge was performed in order to clarify this question.After re-challenge with the test chemical, the animals that had reacted after the fist challenge failed to react. Since the skin reaction observed after the fist challenge was not reproducible upon re-challenge the animals were not considered sensitized against the test chemical. Hence, the test chemical can be considered to be not sensitzing to skin.
- Executive summary:
The guinea pig maximization test was performed according to OECD Test Guideline No. 406 (OECD, 1992), EC guideline B.6 (EC, 1996) and the US EPA Guideline OPPTS 870.2600 (US EPA, 2003). A range finding for the test concentrations was performed in a preliminary experiment assessing the irritant effects of the test compounds after intradermal and topical application. Each test was performed with 10 test and five control animals because this number of animals has been reported as sufficient for the GPMT. The animals received two induction treatments, an intradermal injection (day 0) and a topical application (day 7), and a topical challenge treatment on day 20. In addition to the requirements of the OECD guideline, a second topical challenge was performed on day 28 in all experiments. The intradermal induction comprised three pairs of injections of 0.1 ml each of 5% test chemical in cottonseed oil, the test compound in a 1:1 (v/v) mixture of FCA/physiological saline and a 1:1 (v/v) mixture of FCA/physiological saline without test compound. The control animals received applications without test substance. Approximately 24 h before the topical induction treatment (day 6) the test animals received a topical application of 0.5 ml of 10% sodium lauryl sulphate in Vaseline in order to create a mild local skin irritation. For test compounds which themselves caused a clear skin irritation at the topical induction concentration used no pretreatment with sodium lauryl sulphate was done. For the topical induction, a gauze patch with 0.5 g of the test chemical was applied to the clipped skin and held under occlusion for 48 h. Control animals received the vehicle without test compound. After a resting period, topical challenge treatments were performed on day 20 and on day 28 by applying 0.5 g of 5% test chemical in vaseline for 24 h under occlusion onto the clipped skin of both test and control animals. Approximately 21 h after removal of the challenge patch, the skin area was cleaned and cleared of hair. About 24 and 48 h after removal of the patch, the skin reaction was observed and recorded according to the Magnusson and Kligman grading scale: grade 0, no reaction, grade 1, slight edema and/or erythema; grade 2, well defined edema and/or erythema; grade 3, moderate edema and/or erythema; grade 4, severe edema and/or erythema. No signs of systemic toxicity were observed for the test chemical in any of the animals. The test chemical caused a grade 1 skin reaction in one animal of the treatment group. The skin reaction was observed 24 and 48 h after patch removal. As from the visible inspection of the treated skin site, a sensitizing reaction cannot be differentiated from a skin irritation reaction, a re-challenge was performed in order to clarify this question.After re-challenge with the test chemical, the animals that had reacted after the fist challenge failed to react. Since the skin reaction observed after the fist challenge was not reproducible upon re-challenge the animals were not considered sensitized against the test chemical. Hence, the test chemical can be considered to be not sensitzing to skin.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data is from safety assessment reports
- Qualifier:
- according to guideline
- Guideline:
- other: Patch test
- Principles of method if other than guideline:
- Human patch test data for the test chemical
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified]
- Microbiological status of animals, when known:
- Age at study initiation: 44 year old male
- Weight at study initiation:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
- IN-LIFE DATES: From: To: - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- saturated solution of the test chemical
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- saturated solution of the test chemical
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period:
- Test groups:
- Control group:
- Site:
- Frequency of applications:
- Duration:
- Concentrations: saturated solution of the test chemical
B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Day(s) of challenge:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Concentrations: saturated solution of the test chemical
- Evaluation (hr after challenge): 48 and 72 hours
OTHER: A 44 year old male presented with eczema-type reactions on his skin in areas that were exposed to steel particles during his job using high pressure cleaning equipment to remove steel particles from construction elements. An initial patch test using steel particles resulted in erythema after 48 hours. The reaction had increased at 72 hours. Further tests were carried out. Various metals salts were tested in the patch test. These tests were repeated three times with identical results. About 30 people were used for the control test - Challenge controls:
- 30 people served as control
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- saturated solution of the test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 1
- Clinical observations:
- no dermal reactions were observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test chemical failed to produce any sensitization reaction at 48 and 72 hours, hence it can be considered to be not sensitizing to skin.
- Executive summary:
A 44 year old male presented with eczema-type reactions on his skin in areas that were exposed to steel particles during his job using high pressure cleaning equipment to remove steel particles from construction elements. An initial patch test using steel particles resulted in erythema after 48 hours. The reaction had increased at 72 hours. Further tests were carried out. Various metals salts were tested in the patch test. These tests were repeated three times with identical results. About 30 people were used for the control test. A patch containing saturated solution of the test chemical was applied on the skin of the male volunteer and observed for reactions till 72 hours. The test chemical failed to produce any sensitization reaction at 48 and 72 hours, hence it can be considered to be not sensitizing to skin.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- WoE report for the skin sensitization potential of the test chemical
- Author:
- Sustainability Support Services (Europe) AB
- Year:
- 2 019
- Bibliographic source:
- Sustainability Support Services (Europe) AB, 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on various test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on various test chemicals
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Iron(II) fumarate
- EC Number:
- 205-447-7
- EC Name:
- Iron(II) fumarate
- Cas Number:
- 141-01-5
- Molecular formula:
- C4H4O4.Fe
- IUPAC Name:
- iron(II) fumarate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Ferrous fumarate
- Molecular formula: C4H4O4.Fe
- Molecular weight : 169.901 g/mol
- Smiles notation : [Fe+2].[O-]C(\C=C\C(=O)[O-])=O
- InChl : 1S/C4H4O4.Fe/c5-3(6)1-2-4(7)8;/h1-2H,(H,5,6)(H,7,8);/q;+2/p-2/b2-1+;
- Substance type:Organic
- Physical state:Solid
Constituent 1
In vivo test system
Test animals
- Species:
- other: 2. guinea pigs; 3. humans
- Strain:
- other: 2. SPF-Hsd Poc: DH
- Sex:
- female
- Details on test animals and environmental conditions:
- 2. TEST ANIMALS
- Source: Female guinea pigs were purchased from Harlan Winkelmann (Borchen, Germany).
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified] : yes
- Microbiological status of animals, when known:
- Age at study initiation:
- Weight at study initiation: 300–500 g at the commencement of the study
- Housing: The guinea pigs were housed in groups in Terluran cages on Altromin saw fiber bedding or Lignocel bedding
- Diet (e.g. ad libitum): Altromin 3122 maintenance diet for guinea pigs or ssniff Ms-H, 4mm V2233-000 complete diet for guinea pigs, rich in crude fiber, totally-pathogen-free), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: The acclimatization period was at least five days.
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 degrees C,
- Humidity (%): 55 ± 10%
- Air changes (per hr): air change rate of at least 10 times/hour
- Photoperiod (hrs dark / hrs light): 12-h light/ dark cycle
- IN-LIFE DATES: From: To:
3.TEST ANIMALS
- Source:
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified]
- Microbiological status of animals, when known:
- Age at study initiation: 44 year old male
- Weight at study initiation:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
- IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- cotton seed oil
- Remarks:
- Study 2
- Concentration / amount:
- Intradermal = 5% test chemical in cottonseed oil
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Remarks:
- Study 2
- Concentration / amount:
- Epicuteanous = 0.5 g of 25% test chemical in vaseline
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Study 3
- Concentration / amount:
- saturated solution of the test chemical
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Remarks:
- Study 2
- Concentration / amount:
- 0.5 g of 10% test chemical in vaseline
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Study 3
- Concentration / amount:
- saturated solution of the test chemical
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 2. Each test was performed with 10 test and five control animals
3. 1 - Details on study design:
- 2. RANGE FINDING TESTS: A range finding for the test concentrations was performed in a preliminary experiment assessing the irritant effects of the test compounds after intradermal and
topical application.
MAIN STUDY
A. INDUCTION EXPOSURE - Intradermal exposure
- No. of exposures: single
- Exposure period:
- Test groups: 10
- Control group: 5
- Site:
- Frequency of applications: three pairs of injections of 0.1 ml each of the test compound i.e 5% test chemical in cottonseed oil ; the test compound in a 1:1 (v/v) mixture of FCA/physiological saline and a 1:1 (v/v) mixture of FCA/physiological saline without test compound.
- Duration: 24 hours
- Concentrations: three pairs of injections of 0.1 ml each of the test compound i.e 5% test chemical in cottonseed oil ; the test compound in a 1:1 (v/v) mixture of FCA/physiological saline and a 1:1 (v/v) mixture of FCA/physiological saline without test compound.
A. INDUCTION EXPOSURE - Intradermal exposure
- No. of exposures: single
- Exposure period: 48 hours
- Test groups: 10
- Control group: 5
- Site:
- Frequency of applications: single
- Duration: 48 hours
- Concentrations: 0.5 g of the 25% test chemical in vaseline
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Concentrations:
- Evaluation (hr after challenge): 48 hours and 72 hours
OTHER:
3. RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period:
- Test groups:
- Control group:
- Site:
- Frequency of applications:
- Duration:
- Concentrations: saturated solution of the test chemical
B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Day(s) of challenge:
- Exposure period:
- Test groups:
- Control group:
- Site:
- Concentrations: saturated solution of the test chemical
- Evaluation (hr after challenge): 48 and 72 hours
OTHER: A 44 year old male presented with eczema-type reactions on his skin in areas that were exposed to steel particles during his job using high pressure cleaning equipment to remove steel particles from construction elements. An initial patch test using steel particles resulted in erythema after 48 hours. The reaction had increased at 72 hours. Further tests were carried out. Various metals salts were tested in the patch test. These tests were repeated three times with identical results. About 30 people were used for the control test - Challenge controls:
- 3. 30 control volunteers
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10% test chemical in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of systemic toxicity were observed for the test substances in any of the animals
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Study 2
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- saturated solution of the test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 1
- Clinical observations:
- no dermal reactions were observed
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- Study 3
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Based on the available studies and applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin.
- Executive summary:
Various studies have been reviewed to evaluate the dermal sensitization potential of the test chemical. The results are mentioned below:
The guinea pig maximization test was performed according to OECD Test Guideline No. 406 (OECD, 1992), EC guideline B.6 (EC, 1996) and the US EPA Guideline OPPTS 870.2600 (US EPA, 2003). A range finding for the test concentrations was performed in a preliminary experiment assessing the irritant effects of the test compounds after intradermal and topical application. Each test was performed with 10 test and five control animals because this number of animals has been reported as sufficient for the GPMT. The animals received two induction treatments, an intradermal injection (day 0) and a topical application (day 7), and a topical challenge treatment on day 20. In addition to the requirements of the OECD guideline, a second topical challenge was performed on day 28 in all experiments. The intradermal induction comprised three pairs of injections of 0.1 ml each of 5% test chemical in cottonseed oil, the test compound in a 1:1 (v/v) mixture of FCA/physiological saline and a 1:1 (v/v) mixture of FCA/physiological saline without test compound. The control animals received applications without test substance. Approximately 24 h before the topical induction treatment (day 6) the test animals received a topical application of 0.5 ml of 10% sodium lauryl sulphate in Vaseline in order to create a mild local skin irritation. For test compounds which themselves caused a clear skin irritation at the topical induction concentration used no pretreatment with sodium lauryl sulphate was done. For the topical induction, a gauze patch with 0.5 g of the test chemical was applied to the clipped skin and held under occlusion for 48 h. Control animals received the vehicle without test compound. After a resting period, topical challenge treatments were performed on day 20 and on day 28 by applying 0.5 g of 5% test chemical in vaseline for 24 h under occlusion onto the clipped skin of both test and control animals. Approximately 21 h after removal of the challenge patch, the skin area was cleaned and cleared of hair. About 24 and 48 h after removal of the patch, the skin reaction was observed and recorded according to the Magnusson and Kligman grading scale: grade 0, no reaction, grade 1, slight edema and/or erythema; grade 2, well defined edema and/or erythema; grade 3, moderate edema and/or erythema; grade 4, severe edema and/or erythema. No signs of systemic toxicity were observed for the test chemical in any of the animals. The test chemical caused a grade 1 skin reaction in one animal of the treatment group. The skin reaction was observed 24 and 48 h after patch removal. As from the visible inspection of the treated skin site, a sensitizing reaction cannot be differentiated from a skin irritation reaction, a re-challenge was performed in order to clarify this question.After re-challenge with the test chemical, the animals that had reacted after the fist challenge failed to react. Since the skin reaction observed after the fist challenge was not reproducible upon re-challenge the animals were not considered sensitized against the test chemical. Hence, the test chemical can be considered to be not sensitzing to skin.
This is supported a case study in which a 44 year old male presented with eczema-type reactions on his skin in areas that were exposed to steel particles during his job using high pressure cleaning equipment to remove steel particles from construction elements. An initial patch test using steel particles resulted in erythema after 48 hours. The reaction had increased at 72 hours. Further tests were carried out. Various metals salts were tested in the patch test. These tests were repeated three times with identical results. About 30 people were used for the control test. A patch containing saturated solution of the test chemical was applied on the skin of the male volunteer and observed for reactions till 72 hours. The test chemical failed to produce any sensitization reaction at 48 and 72 hours, hence it can be considered to be not sensitizing to skin.
Based on the available studies and applying the weight of evidence approach, the test chemical can be considered to be not sensitizing to skin.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.