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EC number: 207-395-0 | CAS number: 467-62-9
- 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment report.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Acute Toxicity, Skin and Eye Irritancy and Skin Sensitization Potential of Ancamine D.
- Author:
- NTRL (National Technical Reports Library)
- Year:
- 1 986
- Bibliographic source:
- NTRL REPORT; OTS0511923; 15/10/1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The primary skin irritation study of 4,4'-Methylenedianiline (CAS No: 101-77-9) was conducted on New Zealand White rabbits according to Draize under occlusive condition.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4,4'-methylenedianiline
- EC Number:
- 202-974-4
- EC Name:
- 4,4'-methylenedianiline
- Cas Number:
- 101-77-9
- Molecular formula:
- C13H14N2
- IUPAC Name:
- 4, 4’- diaminodiphenylmethane
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):4,4'-Methylenedianiline
- Molecular formula :C13H14N2
- Molecular weight :198.268 g/mol
- Substance type:Organic
- Physical state:Solid
-Smiles: c1(Cc2ccc(N)cc2)ccc(N)cc1
-InChI: 1S/C13H14N2/c14-12-5-1-10(2-6-12)9-11-3-7-13(15)8-4-11/h1-8H,9,14-15H2
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):4,4'-Methylenedianiline
- Molecular formula :C13H14N2
- Molecular weight :198.268 g/mol
- Substance type:Organic
- Physical state:Solid
-Smiles: c1(Cc2ccc(N)cc2)ccc(N)cc1
-InChI: 1S/C13H14N2/c14-12-5-1-10(2-6-12)9-11-3-7-13(15)8-4-11/h1-8H,9,14-15H2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits Crawley, Suasex
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- Amount :500mg
concentration applied :100% - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 8 (4/sex)
- Details on study design:
- TEST SITE
- Area of exposure: shoulders and the hindquarters
- Type of wrap if used: occlusive polyethylene which was secured in position by mean of an elastic adhesive bandage (3" Poroplast).
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: after 24 hours
SCORING SYSTEM: Draize method.
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- In one rabbit, the abraded patch had a 'bruised' appearance, this was thought to be due to damage of the dermis during abrasion.
Any other information on results incl. tables
TABLE:1.ERYTHEMA AND OEDEMA SCORING SYSTEM |
|
ERYTHEMA |
OEDEMA |
No erythema =0 |
No oedema =0 |
Pale pink =1 |
Soft skin =1 |
Redness =2 |
Oedema =2 |
Severe redness =3 |
More definite oedema =3 |
Beet redeness =4 |
Severe oedema =4 |
TABLE:2.Primary irritation scores |
||||||||||
Animal No. |
Sex |
Response |
24 hours |
48 hours |
72 hours |
7 days |
||||
Ab |
N-AB |
Ab |
N-AB |
Ab |
N-AB |
Ab |
N-AB |
|||
51 |
Male |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
52 |
Male |
Erythema |
0-1 |
0-1 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
53 |
Male |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
54 |
Male |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
55 |
Female |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
56 |
Female |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
57 |
Female |
Erythema |
2-3* |
0 |
2 |
0 |
1 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
58 |
Female |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Reading: 0=no erythema to 4= beet redness; Reading :0=no oedema to 4=severe oedema comments: Abrasions deeper than stratum corneum Note: Ab= Abraded patch ; N-Ab= Not abraded patch |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Irritating
- Conclusions:
- The test chemical 4,4'-Methylenedianiline (CAS No: 101-77-9) was considered to be not irritating to the New Zealand White rabbits’ skin.
- Executive summary:
The primary skin irritation study of 4,4'-Methylenedianiline (CAS No: 101-77-9) was conducted on eight (4/sex)New Zealand White rabbits according to Draize method to determine its skin irritation efficacy.
The 500mg of undiluted chemical was applied to the intact and abraded skin of shornshoulders and the hindquartersof each rabbit under occlusive condition for 24 hours. A 2 x 2 cm area of the shorn skin was abraded using a fine hypodermic needle. Injuries were deep enough to disturb the stratum corneum but not sufficiently deep to cause bleeding. The patches were covered by an occlusivepolyethylene which was secured in position by mean of an elastic adhesive bandage (3" Poroplast).
Reactions were assessed visually for the degree of erythema and oedema upto 7 days. In one rabbit, the abraded patch had a bruised appearance. This was thought to be due to damage of the dermis during abrasion.
Since none of the rabbit showed erythema or edema, the chemical 4,4'-Methylenedianiline (CAS No: 101-77-9) was considered to be not irritating to the New Zealand White rabbits’ skin.
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