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EC number: 200-521-5 | CAS number: 61-82-5
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28-31 August 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP study conducted in compliance with OECD Guideline 404 with minor deviations: temperature and relative humidity recorded were sometimes outside of the target ranges; systemic effects not followed; individual animal weights not reported
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- dated 17 July 1992
- Deviations:
- yes
- Remarks:
- temperature and relative humidity recorded were sometimes outside of the target ranges; systemic effects not followed; individual animal weights not reported
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- dated 31 July 1992
- Deviations:
- yes
- Remarks:
- temperature and relative humidity recorded were sometimes outside of the target ranges; systemic effects not followed; individual animal weights not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amitrole
- EC Number:
- 200-521-5
- EC Name:
- Amitrole
- Cas Number:
- 61-82-5
- Molecular formula:
- C2H4N4
- IUPAC Name:
- amitrole
- Test material form:
- solid: flakes
- Remarks:
- whitish flakes
- Details on test material:
- - Expiration date of the lot/batch: 18 November 2001
- Purity test date: 27 January 2000
- Storage condition of test material: At room temperature protected from light and humidity; in its original packaging
- pH at the concentration of 10% in purified water: 7
Constituent 1
- Specific details on test material used for the study:
- Date of receipt: 14 August 2001
Name as cited in the report: AMITROLE
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Weight at study initiation: 2.6 ± 0.1 kg
- Housing: Animals were housed individually in polystyrene cages.
- Diet (e.g. ad libitum): 110 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France), ad libitum
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3°C
- Relative humidity: 30-70%
- Photoperiod: 12 hours/12 hours
- Air changes: Approximately 12 cycles/hour of filtered, non-recycled air
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: Flanks
- Type of wrap if used: Test item in its original form was placed on a moistened gauze pad, which was then applied to the right flank of the animals for 4 hours. The test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours
- After removal of the dressing, any residual test item was wiped off by means of a dry gauze pad.
OBSERVATION TIME POINTS
- 1 hour, 24, 48 and 72 hours
SCORING SYSTEM:
- Scoring system: According to OECD Guideline 404
- Method of calculation: All scores obtained at each reading time (24, 48 and 72 hours) for an effect were used for calculating the respective mean values.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- A very slight erythema was noted in all animals on Day 1; it persisted up to Day 2 in one animal and up to Day 3 in another one. No other cutaneous reactions were observed.
- Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1 : Individual skin reactions
Rabbits No. |
1 |
2 |
3 |
|
Erythema |
1 h |
1 |
1 |
1 |
24 h |
1 |
0 |
1 |
|
48 h |
1 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
Mean (24, 48 and 72 hours) |
0.7 |
0 |
0.3 |
|
Oedema |
1 h |
0 |
0 |
0 |
24 h |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
Mean (24, 48 and 72 hours) |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions and in accordance with Regulation EC No. 1272/2008 (CLP), the test item was considered as non-irritant to skin. It corresponds to UN GHS No Category. No hazard statement or signal word is required.
- Executive summary:
In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, a single dose of 500 mg of the test item in its original form was applied under semi-occlusive dressing for 4 hours to the closely-clipped skin of one flank of three male New Zealand White rabbits. After removal of the dressing, cutaneous reactions were scored as outlined in the OECD Guideline 404 at 1, 24, 48 and 72 hours.
A very slight erythema was noted in all animals on Day 1; it persisted up to Day 2 in one animal and up to Day 3 in another one. No other cutaneous reactions were observed. Mean scores over 24, 48 and 72 hours for each animal were 0.7, 0.0 and 0.3 for erythema and 0.0, 0.0 and 0.0 for oedema.
Under the test conditions and in accordance with Regulation EC No. 1272/2008 (CLP), the test item was considered as non-irritant to skin. It corresponds to UN GHS No Category. No hazard statement or signal word is required.
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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