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EC number: 200-543-5 | CAS number: 62-56-6
- 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
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- Nanomaterial pour density
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- 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

Endpoint summary
Administrative data
Description of key information
Skin:
Five studies are available on skin irritation of thiourea. A study conducted by the CIVO Institute (1983), a study by Korte and Greim (1981) and a publication by Kosova (1970). In all studies thiourea did not induce skin irritation; results from a study on dermal absorption reports slight irritation at a dose of 2.000 mg/kg (TNO 1978).
Eye:
Three studies are available on eye irritation of thiourea. Korte and Greim (1981) reported thiourea to be slightly irritating but not subject to classification. In a study by TNO (1983) a 10 % thiourea solution was shown to be not irritating to the eye. The UBA-FB 1982) reports slight, reversible irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure 4h, no reading after 1 h and 48 h; animals are treated on intact and abraded skin
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g undiluted test material - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 12
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch²
- Type of wrap if used: surgical patch, adhesive tape, impervious material to wrap
SCORING SYSTEM: Draize and CIVO grading - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of the animals with intact skin
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of the animals with intact skin
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of the animals with intact skin
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of the animals with abraded skin
- Time point:
- 24 h
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: only in one animal very slight scaliness was observed after 72 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: one of six animals showed very slight scaliness after 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Other effects:
- No other effects were observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- On the basis of the results it is concluded that undiluted thiourea is a very slight to slight primary skin irritant but not relevant for classification.
- Executive summary:
In a primary dermal irritation study 12 healthy, adult New Zealand White albino rabbits were dermally exposed to 0.5 g of undiluted thiourea on 1 inch² of the body surface area on the back of the animals. Test sites were covered with an occlusive dressing for 24 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize (1944) and the CIVO grading system. After 24 hours dermal effects were observed in seven out of twelve rabbits. These effects consisted of very slight to well-defined erythema with or without very slight or slight oedema. After 72 hours one rabbit treated on the abraded skin showed slight scaliness. No other dermal effects were observed. In this study, thiourea is very slightly to slightly irritatin but not relevant for classification.
Reference
Table 1: Individual and average skin irritation scores of undiluted thiourea
Rabbit number | Intact skin | Rabbit number | Abraded skin | ||||
24 hours | 72 hours | 24 hours | 72 hours | ||||
A | B | A | B | ||||
1 | 1 | 0 | 0 | 7 | 2 | 2 | 1 |
2 | 0 | 0 | 0 | 8 | 2 | 0 | 0 |
3 | 1 | 2 | 0 | 9 | 0 | 0 | 0 |
4 | 1 | 1 | 0 | 10 | 0 | 0 | 0 |
5 | 0 | 0 | 0 | 11 | 1 | 1 | 0 |
6 | 0 | 0 | 0 | 12 | 1 | 0 | 0 |
average | 1.0 | 0 | average | 1.5 | 0.2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: Entwurf der Prüfungsvorschrift der OECD "Short term toxicology group, Acute eye irritation/corrosivity" vom 31.12.1979
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: own breed
- Age at study initiation: no data
- Weight at study initiation: 2.5 to 2.8 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 60% +/- 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye of the animals served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg or 0.1 mL (1 g equates to 1.5 mL)
- Concentration: n.a.
VEHICLE
- Amount applied: no vehicle
- Concentration: n.a.
- Lot/batch no.: n.a.
- Purity: n.a. - Duration of treatment / exposure:
- The substance is put into the left eye and kept close for 1 second. The substance was not washed out the eye. The exposure was throughout the observation period.
- Observation period (in vivo):
- An observation of the animals was done immediatetly after the application and 1, 24, and 72 hours after apllication of the test substance.
- Number of animals or in vitro replicates:
- 6 male Himalayan rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: n.a.
SCORING SYSTEM: The scoring was done after Draize et al. 1944
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: There were no individual animal data available.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: There were no individual animal data available.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: There were no individual animal data available.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Other effects:
- No other effects were reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study Thiourea is not considered to be irritation to the eye.
- Executive summary:
In a primary eye irritation study similar to the OECD guideline 405, 100 mg Thiourea were instilled undiluted without any vehicle into the conjunctival sac of the left eye of 6 male Himalayan rabbits. The eye lids were kept close for 1 second and the application lasted during the whole observation period for 72 hours as the eyes were not washed after application. Animals were observed immediately after application, and 1, 24 and 72 hours after the treatment. Irritation was scored according to Draize et al. (1944). Fluorescein was used to assess the score. The right eye in which 0.1 ml isotonic NaCl were instilled served as control.
A deficiency of the study is that there is no detailled documentation of individual animal data. Due to the fact that thiourea is not considered to be irritating in this eye irritation test and the detailled description of the procedure of the test this fact can be neglected.
The scores were reported as mean. Thiourea is reported to be not irritating to the eye. Nevertheless a with respect to the conjunctiva an irritation score of 1-2 has been reported for swelling and redness.
Reference
No effects were reported after examination of the eyes following the fluorescein treatment.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Thiourea was shown to be non-irritating to the skin and the eyes according to the CLP. A study conducted by the CIVO Institute (1983) showed that undiluted thiourea is a very slight to slight primary skin irritant but scores were below the threshold for classification. In a study by Korte and Greim (1981) no erythema and oedema were observed. In a publication by Kosova (1970) thiourea did not induce skin irritation.
Three studies are available on eye irritation of thiourea. Korte and Greim (1981) reported thiourea to be slighlty irritating to the eyes. In a study by TNO a 10 % thiourea solution was shown to be not irritating to the eye. This study was rated as reliable. Nevertheless it is not adequate as a 10 % solution of Thiourea was tested.
Taken together the results of the studies show that thiourea is slightly irritating to the skin and to the eyes but irritation scores are below the threshold for classification.
Justification for selection of skin irritation / corrosion endpoint:
key study, supported by Korte & Greim, 1981; Kosova 1970; TNO 1978
Justification for selection of eye irritation endpoint:
key study; supported by TNO 1983
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data Thiourea is only very slightly to slightly irritating to the skin with scores below the threshold for classification. The same applies for irritation to the eyes based on the results of appropriate studies. For this reason Thiourea does not need to be classified for skin and eye irritation according to Regulation (EC) No 1272/2008 (CLP), as amended for the seventeenth time in Regulation (EU) No 2021/849.
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