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Diss Factsheets
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EC number: 229-563-2 | CAS number: 6610-29-3
- 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
- Study period:
- 2001-04-03 to 2001-04-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study (OECD 404)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Minor deviations were not considered to have compromised the validity or integrity of the study : the relative humidity recorded in the animal room was sometimes outside of the target ranges ; the animals were given 110 pelleted
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-methylthiosemicarbazide
- EC Number:
- 229-563-2
- EC Name:
- 4-methylthiosemicarbazide
- Cas Number:
- 6610-29-3
- Molecular formula:
- C2H7N3S
- IUPAC Name:
- 1-amino-3-methylthiourea
- Details on test material:
- other name: MTSC
batch number: 00-11-001-050
Sponsor's filing number: CAL 551/01
description: white powder container: one plastic flask
date of receipt: 15 February 2001
storage conditions: at room temperature, protected from light and humidity
purity: 99.7%
expiry date: January 2002.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Sex: male
- Source: CEGAV (Saint Mars d'Egrenne, France)
- Age at study initiation: no data
- Weight at study initiation: 2.6 ± 0.5 kg
- Housing: individually in polystyrene cages
- Diet (e.g. ad libitum): free access to 110 pelleted diet (UAR, Villemoisson, Epinay¬sur-Orge, France).
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped using electric clippers
- Vehicle:
- other: none
- Controls:
- not required
- Amount / concentration applied:
- undiluted
Purified water (prepared at CIT by reverse osmosis) was used in order to moisten the test substance and ensure a good contact with the skin. - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 3 days (because no effect were observed at 72 hours)
- Number of animals:
- 3
- Details on study design:
- ADMINISTRATION:
- Area of exposure: left flank (3-minute exposure) and right flank (4-hour exposure)
- Total quantity applied: 500 mg
- Administration frequency: once
- Removal of test substance: residual is wiped with a dry gauze pad
EXAMINATIONS:
- Scoring system: Draize's score
- Examination time points: 1h, 24 h, 48 h and 72 hours after the patch removal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 hours
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Scores of 3 rabbits were: 0.3, 0.0 and 0.0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Scores of 3 rabbits were 0.0
- Irritant / corrosive response data:
- After a 3-minute exposure: No cutaneous reaction were noted in any rabbits.
After a 4-hour exposure: A very slight erythema (grade 1) was observed in one rabbit at 1h and 24h after patch removal. This erythema disappeared thereafter. Other rabbits did not exhibit any cutaneous reactions. - Other effects:
- none
Any other information on results incl. tables
Table : individual cutaneous examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for each animal (application for 4 hours)
Rabbit number |
Dermal irritation |
scores |
Mean irritation score (1) |
|||
1h (D1) |
24h (D2) |
48h (D3) |
72h (D4) |
|||
993 |
Erythema |
1 |
1 |
0 |
0 |
0.3 |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
* |
* |
* |
* |
|
|
578 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
* |
* |
* |
* |
|
|
993 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
Oedema |
0 |
0 |
0 |
0 |
0.0 |
|
Other |
* |
* |
* |
* |
|
(1) mean of scores on days 2, 3 and 4
* : none
D = day, h = hour
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Regulation EC no.1272/2008
- Conclusions:
- Under these experimental conditions, the test substance MTSC is non-irritant when applied topically to rabbits.
- Executive summary:
The potential of the test substance MTSC to induce skin irritation was evaluated in rabbits according to OECD 404 and in compliance with the principles of Good Laboratory Practice Regulations.
In the first instance, the test substance was applied for periods of 3 minutes and 4 hours to a single male New Zealand White rabbit. Since the test substance was not severely irritant on this first animal, it was then applied for 4 hours to two other animals. A single dose of 500 mg of the test substance in its original form was applied to the closelyclipped skin of one flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.
After a 3-minute exposure (one animal): No cutaneous reactions were observed.
After a 4-hour exposure (three animals): A very slight erythema was noted in one animal on days 1 and 2. No other cutaneous reactions were observed.
Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for oedema.
Under these experimental conditions, the test substance MTSC is non-irritant when applied topically to rabbits.
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