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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2001-04-10 to 2001-04-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study (OECD 405)
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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- minor deviations were not considered to have compromised the validity or integrity of the study : relative humidity, animal breeder's and diet.
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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 ± 0.3 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, untreated eye
- Amount / concentration applied:
- undiluted
; The test substance was used in its original form.
Amount applied: 100 other: mg - Duration of treatment / exposure:
- a single exposure
- Observation period (in vivo):
- 6 days (because no effect was observed at day 6)
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- Comment: not rinsed
EXAMINATIONS:
- Ophthalmoscopic examination: Yes
- Scoring system: Draize's scale
- Observation period: 1h, 24h, 48h and 72h after administration of the test substance
- Tool used to assess score: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (chemosis)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 hours
- Score:
- 0.87
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: Individual scores were : 1.3, 1.0 and 0.3
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 hours
- Score:
- 1.47
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- other: Individual scores were : 1.7, 1.0 and 1.7
- Irritation parameter:
- conjunctivae score
- Remarks:
- (discharge)
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- other: 24-48-72 hours
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Individual scores were: 0.3, 0.3 and 0.0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 hours
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Individually scores were: 0.3, 0.0 and 0.0
- Irritation parameter:
- cornea opacity score
- Remarks:
- (intensity)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 hours
- Score:
- 0.43
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: Individually scores were: 1.3, 0.0 and 0.0
- Irritation parameter:
- cornea opacity score
- Remarks:
- (area)
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 hours
- Score:
- 0.43
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: Individually scores were: 1.3, 0.0 and 0.0
- Irritant / corrosive response data:
- Very slight or slight conjunctival reactions were observed in an animals from day 1: a very slight or slight chemosis (grade 1 or 2), a very slight or slight redness of the conjunctiva (grade 1 or 2) and a clear discharge were noted. Some of the se reactions persisted up to day 5 at the latest. A slight iritis (grade 1) was noted in one animal, on day 2 only. A very slight or slight corneal opacity (grade 1 or 2) was recorded in the same animal, from day 2 up to day 4. Mean scores calculated for each animal over 24, 48 and 72 bourg were 1.3, 1.0 and 0.3 for chemosis, 1.7, 1.0 and 1.7 for redness of the conjunctiva, 0.3, 0.0 and 0.0 for iris lesions and 1.3, 0.0 and 0.0 for comeal opacity.
- Other effects:
- none
Any other information on results incl. tables
Table 1: Individual ocular examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for each animal
Rabbit number |
Region of eye |
Description of ocular reactions |
scores |
Mean irritation score (1) |
|||||
1h (D1) |
24h (D2) |
48h (D3) |
72h (D4) |
(D5) |
(D6) |
||||
993 |
conjunctivae |
Chemosis |
1 |
2 |
1 |
1 |
0 |
- |
1.3 |
Redness |
1 |
2 |
2 |
1 |
0 |
- |
1.7 |
||
Discharge |
1 |
1 |
0 |
0 |
0 |
- |
0.3 |
||
Iris |
0 |
1 |
0 |
0 |
0 |
- |
0.3 |
||
Corneal opacity |
Intensity |
0 |
2 |
1 |
1 |
0 |
- |
1.3 |
|
Area |
0 |
2 |
1 |
1 |
0 |
- |
1.3 |
||
Other |
* |
* |
* |
* |
* |
- |
|
||
Fluorescein |
/ |
U |
U |
U |
U |
- |
|
||
579 |
conjunctivae |
Chemosis |
1 |
1 |
1 |
1 |
0 |
- |
1.0 |
Redness |
1 |
1 |
1 |
1 |
0 |
- |
1.0 |
||
Discharge |
1 |
1 |
0 |
0 |
0 |
- |
0.3 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
- |
0.0 |
||
Corneal opacity |
Intensity |
0 |
0 |
0 |
0 |
0 |
- |
0.0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
- |
0.0 |
||
Other |
* |
* |
* |
* |
* |
- |
|
||
Fluorescein |
/ |
U |
/ |
/ |
/ |
- |
|
||
566 |
conjunctivae |
Chemosis |
2 |
1 |
0 |
0 |
0 |
0 |
0.3 |
Redness |
2 |
2 |
2 |
1 |
1 |
0 |
1.7 |
||
Discharge |
1 |
0 |
0 |
0 |
0 |
0 |
0.0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
||
Corneal opacity |
Intensity |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
|
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
||
Other |
Su |
* |
* |
* |
* |
* |
|
||
Fluorescein |
/ |
U |
/ |
/ |
/ |
/ |
|
(1) mean of scores on days 2, 3 and 4
* : none
U: fluorescein batch No.D616
/: fluorescein not used
Su: residual test substance
- : ocular examination not performed
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information but not classified Criteria used for interpretation of results: other: Regulation EC n°1272/2008
- Conclusions:
- Under these experimental conditions, the test substance 4 -methylthiosemicarbazide is slightly irritant when administered by ocular route to rabbits.
- Executive summary:
The potential of the test substance 4 -methylthiosemicarbazide to induce ocular irritation was evaluated in rabbits according to OECD 405 and with the principles of Good Laboratory Practice Regulations.
A single dose of 100 mg of the test substance in its original form was introduced into the left conjunctival sac of three male New Zealand White rabbits. The right eye was not treated andserved as control. The eyes were not rinsed after administration of the test substance. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.
Very slight or slight conjunctival reactions (very slight or slight chemosis, very slight or slight redness of the conjunctiva and clear discharge) were observed in all animals from day 1: some of these reactions persisted up to day 5 at the latest.
A slight iritis was noted in one animal, on day 2 only. A very slight or slight corneal opacity was recorded in the same animal, from day 2 up to day 4.
Mean scores calculated for each animal over 24, 48 and 72 hours were 1.3, 1.0 and 0.3 forchemosis, 1.7, 1.0 and 1.7 for redness of the conjunctiva, 0.3, 0.0 and 0.0 for iris lesions and 1.3,0.0 and 0.0 for corneal opacity.
Under these experimental conditions, the test substance 4 -methylthiosemicarbazide is slightly irritant when administered by ocular route to rabbits.
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