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EC number: 203-584-7 | CAS number: 108-45-2
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guide to Labeling of Dangerous Substances published in the Official Journal of European Communiites (EEC Directive 93/21, Annex VI).
- GLP compliance:
- not specified
Test material
- Reference substance name:
- m-phenylenediamine
- EC Number:
- 203-584-7
- EC Name:
- m-phenylenediamine
- Cas Number:
- 108-45-2
- Molecular formula:
- C6H8N2
- IUPAC Name:
- m-phenylenediamine
- Details on test material:
- - Purity: 99%
-Physical Form: Purple to black flake.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: Hare Marland, Hewitt, New Jersey.
Housing: Single, in suspended, stainless steel, wire-mesh cages.
Food: Purina Certified High Fiber Rabbit Chow #5325, ad libitum, except during exposure.
Water: Ad libitum except during exposure.
Weight: 2074-2162 g
Light/Dark Cycle: 12/12
Temperature: 20ºC ± 1
Humidity: 50% ± 10%
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: other areas on test animals' body was used for comparison (control)
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, and 48 hours
- Number of animals:
- 6
- Details on study design:
- On the day prior to treatment, the hair of 6 male rabbits was closely shaved to expose the skin from the scapular to the lumbar region of the back. Each rabbit was placed into a stock which had been fitted with a piece of rubber sheeting, approximately 8" x 18". The rabbits remained in the stocks throughout the exposure period and during that time did not have access to food or water. Approximately 0.5 g of the test substance, moistened with deionized water prior to dosing, was applied directly to the test site and was covered with a 2" gauze square. The gauze square was held in place with non-irritating tape. The rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test substance in contact with the skin without undue pressure. Approximately 4 hours after application of the test substance, the rubber sheeting was loosened, and the skin at the corners of the gauze squares was marked with a waterproof pen. Wrappings and gauze squares were then removed. The test sites were gently washed with soap and warm water to remove excess test substance. The skin was gently patted dry and the animals were returned to their cages. Approximately 1, 24, and 48 hours after removal of the test substance, the test sites were evaluated for erythema, edema, and other evidence of dermal effects and were scored according to the Draize scale. The adjacent areas of the untreated skin were used for comparison. Additionally, the rabbits were examined for clinical signs of toxicity at each dermal evaluation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- other: not reversible in 48 hours
- Remarks on result:
- other: Evaluations made up to 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Evaluations made up to 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Evaluations made up to 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Evaluations made up to 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- other: not reversible in 48 hours
- Remarks on result:
- other: Evaluations made up to 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Evaluations made up to 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Evaluations made up to 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Evaluations made up to 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Evaluations made up to 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Evaluations made up to 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Evaluations made up to 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Evaluations made up to 48 hours
- Irritant / corrosive response data:
- The test substance produced slight erythema in 3 rabbits and mild erythema in 3 rabbits at 1 hour after the test substance was removed. No edema was observed. By 24 hours, 2 rabbits exhibited slight erythema but no edema and 4 rabbits exhibited mild erythema and slight edema. Four rabbits were clear of all dermal irritation and 2 rabbits exhibited slight erythema but no edema by 48 hours after removal of the test substance.
See results tables 1 and 2 for further details. - Other effects:
- In addition, the test sites of 2 rabbits were stained gray by the test substance. No clinical signs of toxicity were observed during the study.
Any other information on results incl. tables
TABLE 1: Summary of Skin Response to the test substance |
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Erythema |
Edema |
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Response |
1 hr |
24 hr |
48 hr |
1 hr |
24 hr |
48 hr |
None |
0/6 |
0/6 |
4/6 |
6/6 |
2/6 |
6/6 |
Slight |
3/6 |
2/6 |
2/6 |
0/6 |
4/6 |
0/6 |
Mild |
3/6 |
4/6 |
0/6 |
0/6 |
0/6 |
0/6 |
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TABLE 2: Individual Skin Irritation Scores |
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Rabbit |
Erythema |
Edema |
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Number |
1 hr |
24 hr |
48 hr |
1 hr |
24 hr |
48 hr |
30374 |
1 |
2 |
1 |
0 |
1 |
0 |
30383 |
1(x) |
1(x) |
0(x) |
0 |
0 |
0 |
30384 |
2 |
2 |
0 |
0 |
1 |
0 |
30385 |
2(x) |
2(x) |
0(x) |
0 |
1 |
0 |
30386 |
2 |
2 |
1 |
0 |
1 |
0 |
30392 |
1 |
1 |
0 |
0 |
0 |
0 |
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(x) = skin stained gray |
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Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance produced slight erythema in 3 rabbits and mild erythema in 3 rabbits at 1 hour after the test substance was removed. No edema was observed. By 24 hours, 2 rabbits exhibited slight erythema but no edema and 4 rabbits exhibited mild erythema and slight edema. Four rabbits were clear of all dermal irritation and 2 rabbits exhibited slight erythema but no edema by 48 hours after removal of the test substance.
- Executive summary:
The irritation potential of the test substance was studied in rabbits. The test substance produced slight erythema in 3 rabbits and mild erythema in 3 rabbits at 1 hour after the test substance was removed. No edema was observed. By 24 hours, 2 rabbits exhibited slight erythema but no edema and 4 rabbits exhibited mild erythema and slight edema. Four rabbits were clear of all dermal irritation and 2 rabbits exhibited slight erythema but no edema by 48 hours after removal of the test substance.
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.
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