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EC number: 700-934-5 | CAS number: -
- 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:
- November 19, 2007 to December 19, 2007 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- reaction products of ethylene glycol, urea and paraformaldehyde
- EC Number:
- 700-934-5
- Molecular formula:
- No exact molecular formula can be given for a complex reaction mixture (UVCB substance).
- IUPAC Name:
- reaction products of ethylene glycol, urea and paraformaldehyde
- Details on test material:
- - Name of test material (as cited in study report): TPI 1618
- Substance type: Formaldehyde releaser
- Physical state: Colourless liquid
- Analytical purity: 100%
- Composition of test material, percentage of components: Reaction product of ethylene glycol, urea and paraformaldehyde
- Purity test date: October 25, 2007
- Lot/batch No.: 1118965
- Expiration date of the lot/batch: December 2008
- Storage condition of test material: dry, room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Russian, Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kißleg
- Age at study initiation: 33 - 36 months
- Weight at study initiation: 2.7-2.9 kg
- Housing: Individually in PPO cages
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +-3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (12 hrs dark / 12 hrs light):
IN-LIFE DATES: From November 10, 2007 to December 19, 2007
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one eye was treated, the other one served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100% - Duration of treatment / exposure:
- Exposure was 24 hours. At this time, fluorescein was instilled and irrigated with 20 mL of a 0.9% of sodium chloride solution.
- Observation period (in vivo):
- 21 days; Eye examinations were performed at 1, 24, 48 and72 hours and on Days 7, 14 and 21
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
SCORING SYSTEM: Cornea
A) Opacity degree of density
No ulceration or opacity: 0
Scattered or diffuse area of opacity: 1
Easily discernable translucent areas: 2
Nacreous areas; no details of iris visible: 3
Complete corneal opacity, iris not discernable: 4
B) Extent of effected area
More than 0 but less than ¼: 1
More than ¼ but less than ½: 2
More than ½ but less than ¾: 3
More than ¾ to whole area: 4
Iris
Normal: 0
Markedly deepened folds and/or
congestion, swelling, moderate circumcorneal
injection but still shows (even delayed) reaction: 1
No reaction to light, hemorrhage, gross destruction: 2
Conjunctiva
A) Reddening
Blood vessels normal: 0
Blood vessels definitely injected: 1
Diffuse crimson red, individual vessels not
easily discernible: 2
Diffuse beefy red: 3
B) Chemosis
No swelling: 0
Swelling above normal
(includes nicitating membrane): 1
Obvious swelling with partial eversion of the lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4
C) Discharge
No discharge: 0
Any amount different from normal
(excluding normal secretion of healthy animals): 1
Discharge with moistening of lids: 2
Discharge with moistening of a wide area
around the eye:
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Slight to well defined changes were found in the cornea, iris and conjunctiva such as scattered or diffuse opacity, markedly deepened rugae, congestion, swelling and moderate circumcorneal hyperemia of the iris and diffuse crimson color as well as obvious swelling and with partial eversion of eyelids, as far as the conjunctivae were concerned.
Findings were near to equal at 24 and 48 hours, but declined slightly after 72 hours. Changes of the cornea were reversible after 14 days and after 7 day in the other eye structures. - Other effects:
- Slight lacrimation
Any other information on results incl. tables
Table: Results of eye irritation
Results of eye irritation study |
Cornea |
Iris |
Conjunctiva |
|
redness |
chemosis |
|||
score (range from 0 to maximum score) |
0 to 4 |
0 to 2 |
0 to 3 |
0 to 4 |
60 min |
0 |
0 |
1 |
1 |
24 h |
1 |
1 |
2 |
2 |
48 h |
1.3 |
0.7 |
2 |
1.7 |
72 h |
1.3 |
0.3 |
1.6 |
1.3 |
Day 7 |
0.3* |
0 |
0 |
0 |
Day 14 |
0.3* |
0 |
0 |
0 |
Day 21 |
0 |
0 |
0 |
0 |
Average 24h, 48h, 72h |
1.2 (1.4*) |
0.8 |
1.9 |
1.7 |
Cornea, area effected 1 h |
0 |
|
|
|
Maximum average score |
1.3 |
0.7 |
2 |
1.7 |
Reversibility |
c |
c |
c |
c |
average time for reversion |
14 days |
7 days |
7 days |
7 days |
Give method of calculation maximum average score. |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- The Test Substance is classified to be Irritating to eyes under the conditions of the test.
- Executive summary:
The local eye irritating potential of TPI 1618 was investigated according to OECD 405 (2002) which equals Commission Directive 2004/73/EC B.5. TPI 1618 was found to be irritating to the eyes of rabbits. Maximal revovry period was 14 days.
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