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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in the seventies, i.e. prior to implementation of guidelines, and GLP was not compulsory at that time. However, the study was well-documented and the reported data are of scientific accetability.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
Materials and methods
- Principles of method if other than guideline:
- Method: other: no data
- GLP compliance:
- no
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:
- No purity specified.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Hylyne Commercial Rabbits, Cheshire
They were housed individually in metal cages.
Administration / exposure
- Type of coverage:
- other: non-occlusive
- Vehicle:
- other: methylcellulose
- Details on exposure:
- Route of Administration: dermal
At a dose level of 1 ml/kg b.w. the daily application of Bronopol at a concentration of 0.2 and 0.5% corresponds to a dose of 2 and 5 mg/kg bw/day
respectively.
Vehicle: 2,5% methylcellulose.
The residual test substance was removed after each treatment period of 6 hours by gentle washing of the skin application site with a warm dilute soap solution, followed by rinsing with clean water; thereafter the skin was blotted dry with absorbent paper. - Duration of treatment / exposure:
- 21 days, 6 hours/day
- Frequency of treatment:
- 7 d/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.2 other: %
- Remarks:
- bronopol in 2.5% methyl cellulose, 1 ml/kg bw, corresponding to 2 mg/kg bw/day
- Dose / conc.:
- 0.5 other: %
- Remarks:
- bronopol in 2.5% methyl cellulose, 1 ml/kg bw, corresponding to 5 mg/kg bw/day
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: none
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations included local skin reaction (erythema and oedema), behavioural changes and
signs of toxicity, food consumption, body weight, haematology (packed cell volume, haemoglobin, red cell count,
total and differential white cell count), clinical chemistry (plasma urea, total serum proteins, serum protein,
serum alkaline phosphatase, serum transaminase (SGPT), ophthalmoscopic examination.
Body weights were recorded at test initiation and weekly thereafter; the group mean value (g/rabbit) was calculated. Food consumption for each rabbit was recorded weekly and the group mean food intake (g/rabbit/week) was calculated. The eyes of the animals were examined prior test start and again after 3 weeks of treatment (Keeler indirect ophthalmoscope). - Sacrifice and pathology:
- Terminal studies after sacrifice of the animals included macroscopic examination and weighing of inner organs
(thyroid, heart, liver, kidneys, adrenals, and gonads) and microscopic examination of a series of tissues
(adrenal, brain, duodenum, eye, gall-bladder, gonads, heart, ileum, kidney, liver, lymph nodes, marrow smear,
mid-colon, pancreas, pituitary, salivary gland, skin (treated and untreated), spleen, stomach
(glandular and non-glandular), thymus, thyroid, urinary bladder. - Statistics:
- Student's t-test and analysis of variance were employed to assess the significance of intergroup differences.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No mortality and no signs of toxicity were observed.
- Dermal irritation:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Local skin reaction (slight to well-defined erythema in 9/10 animals, and slight edema in all animals) was observed in the control rabbits. Similar irritation was seen in rabbits treated with Bronopol 0.2% although possibly with slightly more edema formation and slightly more persistent.Bronopol 0.5% treatment caused progression of slight to well-defined erythema to moderate erythema in 9/10 animals. Edema occurred on the third day and became well defined in all rabbits. Moderate edema developed in 3/5 males.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Initial loss of body weight was seen in all groups including controls; weight gain was comparable and no treatment related trend could be observed which would indicate a specific effect of Bronopol on growth.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Food consumption of all male and female animals was normal except for 2 animals in group 2 (0.2%) and one animal in group 3 (0.5%) where food consumption was depressed.
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- Ophthalmoscopic examination revealed no abnormalities.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Haematology and clinical chemistry were inconspicious.
- Clinical biochemistry findings:
- no effects observed
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The macroscopical examination of the treated skin areas at necropsy revealed a varying degree of inflammatory reaction in control (2 cases) and in the 0.5% bronopol group (one case).One animal treated with 0.2% bronopol showed an isolated area of hyperkeratosis. One animals of the 0.2% bronopol group and 4 animals of the 0.5% bronopol group showed areas of dermal scarring (1 to 8 mm in length). All these reactions were considered to be non-specific and without toxicological significance. Areas of scabbing with associated dermal inflammation were seen in 2 animals treated with 0.5% bronopol. A similar effect also was seen in an animal of the 0.2% bronopol group, however within an untreated skin area. Therefore, this effect was considered to rather be related to the scarification of the skin than to the treatment with bronopol.
Neither gross- nor histopathological treatment-related changes were seen; organ weights were inconspicious. - Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- Local skin reaction (slight to well-defined erythema in 9/10 animals, and slight edema in all animals)was observed in the control rabbits. Similar irritation was seen in rabbits treated with Bronopol 0.2% although possibly with slightly more edema formation and slightly more persistent.Bronopol 0.5% treatment caused progression of slight to well-defined erythema to moderate erythema in 9/10 animals. Edema occurred on the third day and became well defined in all rabbits. Moderate edema developed in 3/5 males. The macroscopical examination of the treated skin areas at necropsy revealed a varying degree of inflammatory reaction in control (2 cases) and in the 0.5% bronopol group (one case).One animal treated with 0.2% bronopol showed an isolated area of hyperkeratosis.One animals of the 0.2% bronopol group and 4 animals of the 0.5% bronopol group showed areas of dermal scarring(1 to 8 mm in length). All these reactions were considered to be non-specific and without toxicological significance. Areas of scabbing with associated dermal inflammation were seen in 2 animals treated with 0.5% bronopol. A similar effect also was seen in an animal of the 0.2% bronopol group, however within an untreated skin area. Therefore, this effect was considered to rather be related to the scarification of the skin than to the treatment with bronopol.
No mortality and no signs of toxicity were observed.
Food consumption of all male and female animals was normal except for 2 animals in group 2 (0.2%) and one animal in group 3 (0.5%) where food consumption was depressed.Initial loss of body weight was seen in all groups including controls; weight gain was comparable and no treatment related trend could be observed which would indicate a specific effect of Bronopol on growth.
Haematology and clinical chemistry were inconspicious.
Ophthalmoscopic examination revealed no abnormalities.
Neither gross- nor histopathological treatment-related changes were seen; organ weights were inconspicious.
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 0.2 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: skin irritation
- Remarks on result:
- other: 2 mg/kg bw/day
- Dose descriptor:
- LOAEL
- Effect level:
- 0.5 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: skin irritation
- Remarks on result:
- other: 5 mg/kg bw/day
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Numerical scores awarded to dermal reactions elicited by Bronopol
(group 1: vehicle control; 2: Bronopol 0.2%; 3: Bronopol 0.5%).
Group | Sex | Animal No. | Reaction | Day 0 | 1 | 2 | 3 | 14 | 21 |
1 | Male | 324 | Erythema | 0 | 1 | 1 | 1 | 1 | 1 |
Oedema | 0 | 0 | 0 | 0 | 1 | 0 | |||
469 | Erythema | 0 | 1 | 1 | 1 | 2 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 1 | |||
478 | Erythema | 1 | 1 | 1 | 1 | 1 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 0 | |||
2438 | Erythema | 0 | 1 | 1 | 1 | 1 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 0 | 0 | |||
327 | Erythema | 0 | 1 | 1 | 1 | 1 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 0 | |||
Female | 350 | Erythema | 0 | 1 | 1 | 1 | 1 | 1 | |
Oedema | 0 | 0 | 0 | 0 | 1 | 2 | |||
2081 | Erythema | 1 | 1 | 1 | 1 | 1 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 0 | |||
2082 | Erythema | 0 | 0 | 0 | 1 | 2 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 0 | |||
332 | Erythema | 0 | 1 | 1 | 2 | 2 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 2 | 2 | |||
344 | Erythema | 0 | 1 | 1 | 1 | 2 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 2 |
Group | Sex | Animal No. | Reaction | Day 0 | 1 | 2 | 3 | 14 | 21 |
2 | Male | 326 | Erythema | 1 | 1 | 1 | 1 | 2 | 1 |
Oedema | 0 | 0 | 0 | 0 | 1 | 1 | |||
330 | Erythema | 1 | 1 | 1 | 1 | 2 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 0 | |||
476 | Erythema | 0 | 1 | 1 | 1 | 2 | 2 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 1 | |||
2054 | Erythema | 1 | 1 | 1 | 1 | 2 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 0 | |||
2473 | Erythema | 0 | 0 | 1 | 1 | 1 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 0 | |||
Female | 342 | Erythema | 0 | 1 | 1 | 2 | 1 | 2 | |
Oedema | 0 | 0 | 0 | 0 | 1 | 2 | |||
2089 | Erythema | 0 | 1 | 1 | 1 | 1 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 0 | 0 | |||
2097 | Erythema | 0 | 1 | 1 | 1 | 1 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 1 | |||
2092 | Erythema | 0 | 1 | 1 | 1 | 1 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 1 | |||
2406 | Erythema | 0 | 1 | 1 | 1 | 2 | 1 | ||
Oedema | 0 | 0 | 0 | 0 | 1 | 1 |
Group | Sex | Animal No. | Reaction | Day 0 | 1 | 2 | 3 | 14 | 21 |
3 | Male | 316 | Erythema | 0 | 2 | 2 | 2 | 3 | 3 |
Oedema | 0 | 0 | 0 | 1 | 3 | 2 | |||
331 | Erythema | 0 | 2 | 2 | 2 | 3 | 3 | ||
Oedema | 0 | 0 | 0 | 1 | 3 | 2 | |||
2057 | Erythema | 0 | 1 | 2 | 2 | 3 | 3 | ||
Oedema | 0 | 0 | 0 | 1 | 2 | 1 | |||
2439 | Erythema | 0 | 1 | 1 | 1 | 3 | 3 | ||
Oedema | 0 | 0 | 0 | 1 | 3 | 3 | |||
2055 | Erythema | 0 | 1 | 1 | 1 | 3 | 3 | ||
Oedema | 0 | 0 | 0 | 1 | 2 | 2 | |||
Female | 336 | Erythema | 0 | 1 | 1 | 1 | 3 | 3 | |
Oedema | 0 | 0 | 0 | 1 | 2 | 2 | |||
354 | Erythema | 0 | 1 | 1 | 2 | 3 | 3 | ||
Oedema | 0 | 0 | 0 | 1 | 2 | 2 | |||
2083 | Erythema | 0 | 1 | 1 | 2 | 3 | 1 | ||
Oedema | 0 | 0 | 0 | 1 | 2 | 1 | |||
335 | Erythema | 0 | 1 | 1 | 2 | 2 | 1 | ||
Oedema | 0 | 0 | 0 | 1 | 1 | 1 | |||
337 | Erythema | 0 | 1 | 1 | 2 | 3 | 1 | ||
Oedema | 0 | 0 | 0 | 1 | 2 | 1 |
Applicant's summary and conclusion
- Conclusions:
- CL-Freetext:
Repeated dermal application of Bronopol at 0.2 and 0.5% in methyl cellulose suspension over a period of 21 days was not associated with signs of systemic toxicity or deaths. Severe skin irritation was observed after application of 0.5% Bronopol, whereas 0.2% Bronopol caused skin reaction comparable to, but slightly more persistent than that elicited by the vehicle alone. Correspondingly, NOAEL- and LOAEL-values of 2 mg/kg bw/day and 5 mg/kg bw/day were estimated on the basis of the skin findings.
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