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Diss Factsheets
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EC number: 200-070-4 | CAS number: 50-89-5
- 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://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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Toxi-Coop ZRT.
Test material
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material: Thymidine
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Adult rabbits
- Weight at study initiation: 2844 - 3085 g
- Housing: Animals were housed individually in metal cages.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES:
- From: 15 Jan. 2013
- To: 19 Jan. 2013
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: The test item was used in pure state, in a single dose of 0.5 g test item - Duration of treatment / exposure:
- In the first step an initial test was performed using one animal. One hour after application of the test item to the sentinel animal, the application site was examined. Severe irritation or corrosive effect was not observed in the initial test, therefore the bandage was replaced and the exposure continued for a further 3 hours (a total 4 hours exposure). 4 hours after the application the rest of the test item was removed using body temperature water. Two additional animals were treated comparably for this study.
- Observation period:
- Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes, 24, 48 and 72 hours after the patch removal.
- Number of animals:
- Three animals
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 6 cm² area of intact skin
- Type of wrap if used: Sterile gauze pads (10 x10cm) were placed on the skin of rabbits. These gauze patches were kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The entire trunks of the animals were wrapped with plastic wrap.
REMOVAL OF TEST SUBSTANCE
- Washing: 4 hours after the application the rest of the test item was removed using body temperature water.
- Time after start of exposure: 4 hours
SCORING SYSTEM
- The dermal irritation scores were evaluated according to the scoring system by Draize (1959) shown in the Appendix III. The animals were observed for 72 hours, the duration of the study was sufficient to evaluate fully the reversibility or irreversibility of the effects observed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours after treatment
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours after treatment
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours after treatment
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- 1 hour after the patch removal well defined erythema (score 2) was observed in two animals (No.: 1, 2) and very slight erythema (score 1) occurred in animal No.: 3. Oedema was not observed in animals during the study.
24 hours after the patch removal well defined erythema (score 2) was recorded in animal No.: 1 and very slight erythema (score 1) was detected in two animals (No.: 2, 3).
48 hours after the patch removal very slight erythema (score 1) was observed in animal No.: 1. Two animals (No.: 2, 3) became free of symptoms.
72 hours after the treatment the study was terminated, since there were no primary irritation symptoms.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) were as follows:
- erythema: 1.00, 0.33, 0.33
- oedema: 0.00, 0.00, 0.00
There were no signs of corrosion. During the study the behaviour and general state of animals were normal. There were no notable body weight changes during the contact and observation period and no signs of systemic toxicity.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Test item treatment caused mild irritation. There were no signs of corrosion. The behavior and general state of animals was normal. No changes to body weight and no systemic toxicity were observed.
- Executive summary:
An acute skin irritation study was performed in New Zealand White rabbits according to EU Method B.4, OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and OPPTS 870.2500. The irritation effects of the test item were evaluated according to the Draize (1959) method.
The test item was administered in pure state, in a single dose of 0.5 g to the hairless skin of all experimental rabbits. The untreated skin of each animal served as control. After 4 hours the rest of the test item was removed with water of body temperature.
The animals were examined at 1, 24, 48 and 72 hours after the patch removal. 1 hour after the patch removal very slight to well defined erythema was observed in animals. 48 hours after the patch removal very slight erythema was found in one animal and two animals became free of symptoms. 72 hours after the treatment the study was terminated, since there were no primary irritation symptoms.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) were as follows:
- erythema: 1.00, 0.33, 0.33
- oedema: 0.00, 0.00, 0.00
There were no signs of corrosion. During the study the behaviour and general state of animals were normal. There were no notable body weight changes during the contact and observation period and no signs of systemic toxicity.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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