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Diss Factsheets
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EC number: 200-143-0 | CAS number: 52-51-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted according to the acknowledged method of Magnusson B and Kligman AM (J. Invest. Dermatol., 52, 268-276, 1969), which preceeded OECD 406.GLP was not compulsory at the time the study was conducted. Few deficiencies were noticed (no positive control; no specification, whether the application sites needed to be cleaned from test substance residues following removal of the test patch; the control groups (treated and untreated) consisted each of 4 animals instead of five, as recommended by OECD guideline) but they do not affect the validity of the reported data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
Materials and methods
- Principles of method if other than guideline:
- The study was conducted according to the acknowledged method of Magnusson B and Kligman AM (J. Invest. Dermatol., 52, 268-276, 1969), which preceeded OECD 406
The method closely followed that of Magnusson and Kligman (1969), however with following deviation: each test was performed with 10 treated animals, 4 treated controls and 4 untreated controls. Furthermore, the test was conducted with 4 challenges, instead of one as prescribed by Magnusson and Kligman (1969). - GLP compliance:
- no
- Remarks:
- GLP was not compulsory at the time the study was conducted.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed before LLNA-method was described as OECD test guideline and before it could be established in the EU-REACH regulation.
Test material
- Reference substance name:
- Bronopol
- EC Number:
- 200-143-0
- EC Name:
- Bronopol
- Cas Number:
- 52-51-7
- Molecular formula:
- C3H6BrNO4
- IUPAC Name:
- 2-bromo-2-nitropropane-1,3-diol
- Test material form:
- not specified
- Details on test material:
- Purity 100%
Constituent 1
- Specific details on test material used for the study:
- Purity 100%
In vivo test system
Test animals
- Species:
- guinea pig
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Mean weight at test initiation: 320 g.
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: 2 induction applications.
- Vehicle:
- other: physiological saline, distilled water
- Concentration / amount:
- 1st application: Induction 0.02 % intracutaneous
2nd application: Induction 1.5 % occlusive epicutaneous
3rd application: Challenge 0.4 % occlusive epicutaneous
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: physiological saline, distilled water
- Concentration / amount:
- 1st application: Induction 0.02 % intracutaneous
2nd application: Induction 1.5 % occlusive epicutaneous
3rd application: Challenge 0.4 % occlusive epicutaneous
- No. of animals per dose:
- Main sensitisation test:
treated group: 6 females and 4 males
treated control group: 4 females
untreated control group: 4 females - Details on study design:
- The test concentrations selected for induction (intradermal injection and epicutaneous occlusive) and challenge were chosen on the basis of the results of two preliminary tests (intradermal injection and topical application) conducted respectively with 4 female animals. The test concentrations for the main sensitisation test were: 0.02% in 0.9% saline for the first induction (intradermal injection), 1.5% in distilled water for the second induction (epicutaneous, occlusive) and 0.04% in distilled water for challenge. The main test was conducted with 50% Freunds Complete Adjuvant, FCA, in saline and consisted of following groups: a treated group with 10 animals (6 females and 4 males), a treated control group with 4 females (induced as treated animals but without test substance; challenge similar to that of treated animals) and an untreated control group with 4 females (untreated animals challenged exactly as treated animals). First induction: 6 x 0.1 ml injections within a 2 cm x 4 cm area of the shoulder region: 2 injections of test substance in solvent, 2 injections of test substance in 50% CFA in saline and 2 injections of 50% CFA in saline. Second induction: occlusive epicutaneous conditions. Application of a 2 cm x 4 cm patch saturated with test substance over the shoulder injection site, covered with an occlusive dressing.Challenges 1 -3: occlusive epicutaneous conditions as above. The first challenge was conducted after 14 days following the second induction; further challenges (3) were conducted at weekly or greater intervals. Fourth challenge: a fourth challenge was added to (1) to check whether sensitization potential is reduced at lower challenge concentrations (test concentrations: 0.2 and at 0.4% in distilled water) and (2) to look for possible cross-challenge, using a 0.5% solution of 40% formaldehyde. The animals were examined for skin reactions: the application site was examined after 24h and 48h following removal of the patch; the findings were scored 0 to +++ (0 indicates no skin reaction; from + upwards, reactions are considered positive, however no reactions must be seen in controls). Furthermore, the body weights of the animals were recorded weekly.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Reading:
- other: third challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.4%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Reading:
- other: third challenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.4%
- No. with + reactions:
- 2
- Total no. in group:
- 10
Any other information on results incl. tables
Within the challenge 4, a cross-challenge was conducted with formaldehyde, as bronopol is reputed to produce formaldehyde under certain conditions.
The results indicate that formaldehyde was not responsible for the positive reactions reported for the remaining challenges. |
The fourth challenge was conducted to see whether the sensitising potential of bronopol decreases with decreasing test concentration.
The findings indicate that the sensitisation was not reduced at 0.2% challenge.
|
The main 48h - results for the different challenges can be summarized as follows:
A sensitisation was observed in 1 animal after 48 hours following the second challenge; after 48 hours following the third challenge, 2 animals still were sensitised. |
The main 24 h - results for the different challenges can be summarized as follows: A sensitisation was observed in 2 animals after 24 hours following the third challenge.
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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