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Diss Factsheets
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EC number: 266-235-8 | CAS number: 66204-44-2
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Partly limited documentation; readings only after 24 h.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: FDA Handbook, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA p. 47
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- at the time the study was performed, GLP was not compulsory
Test material
- Reference substance name:
- Grotan® OX
- IUPAC Name:
- Grotan® OX
- Details on test material:
- - Name of test material (as cited in study report): Grotan® OX
- Substance type: Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2)
- Physical state: Liquid
- Lot/batch No.: Ch B 9190
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- No data
ENVIRONMENTAL CONDITIONS
- No data
IN-LIFE DATES: No data
Test system
- Vehicle:
- water
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): a) undiluted b) 0.2% dilution - Duration of treatment / exposure:
- a) 24 h (unwashed) in 3 animals or b) 4 seconds (washed with 20 mL lukewarm water) in 3 animals.
(Procedure used for both, 100% and 0.2% treatment). - Observation period (in vivo):
- All animals in a) and b) sacrificed 24 h after instillation
- Number of animals or in vitro replicates:
- 6 per concentration
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure: Animals treated with the 100% solution remained unwashed, Animals treated with the 0.2% dilution weer washed 4 seconds after instillation
SCORING SYSTEM:
Scoring system corresponds to OECD guideline 405.
Additionally the area of the cornea involved was scored:
1 one quarter or less but not zero
2 greater than on quarter but less than half
3 greater than half but less than ¾
4 greater than 3/4
Discharge of the conjunctivae also scored:
1 Any amount different from normal
2 Discharge with moistening of lids and hairs just adjacent to lids
3 Discharge with moistening of lids and hairs, and considerable area around the eye
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- >= 2.3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Score refers to undiluted solution, unwashed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- >= 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Score refers to undiluted solution, unwashed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- >= 3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Score rfers to undiluted solution, unwashed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- >= 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: Score refers to undiluted solution, unwashed
- Irritant / corrosive response data:
- The undiluted substance produced severe ocular reactions which are presumed to be permanent. Similar effects were noted after a short exposure period (washed eyes, see Table below)). In view of these effects the animals were sacrificed 24 hours after instillation.
In contrast to the undiluted substance the 0.2% solution in water caused only slight transient conjunctival responses and no effects on iris and cornea (see Table). - Other effects:
- No data
Any other information on results incl. tables
Results of eye irritation study (average of 3 animals investigated in each group)
|
Cornea |
Iris |
Conjunctivae |
|
redness |
chemosis |
|||
score |
0 to 4 |
0 to 2 |
0 to 3 |
0 to 4 |
undiluted test substance, unwashed |
||||
24 h (animals sacrificed, no further readings) |
2.3 |
2.0 |
3.0 |
4.0 |
24 h area effected cornea (score see above) |
4.0 |
|
|
|
24 h maximum average score (including area affected & discharge of conjunctivae, total max. 110) |
47 (max 80) |
10 (max 10) |
20 (max. 20) |
|
Reversibility* |
- |
- |
- |
- |
24 h: Discharge of conjunctivae average score 3.0 |
||||
undiluted test substance, washed |
||||
24 h (animals sacrificed, no further readings) |
1.7 |
2.0 |
3.0 |
4.0 |
24 h area effected cornea (score see above) |
3.7 |
|
|
|
24 h maximum average score (including area affected & discharge of conjunctivae, total max. 110) |
32 (max 80) |
10 (max 10) |
20 (max. 20) |
|
Reversibility* |
- |
- |
- |
- |
24 h: Discharge of conjunctivae average score 3.0 |
|
|
|
|
|
Cornea |
Iris |
Conjunctivae |
|
redness |
chemosis |
|||
0.2% test substance in water, unwashed |
||||
24 h |
0.0 |
0.0 |
0.7 |
0.0 |
48 h (same results with further readings) |
0.0 |
0.0 |
0.0 |
0.0 |
24 h maximum average score (including area affected & discharge of conjunctivae, total max. 110) |
0 (max 80) |
0 (max 10) |
1.3 (max. 20) |
|
Reversibility |
- |
- |
complete |
- |
Discharge of conjunctivae average score 0.0 (all readings) |
|
|
|
|
0.2% test substance in water, washed |
||||
24 h |
0.0 |
0.0 |
0.3 |
0.3 |
48 h (same results with further readings) |
0.0 |
0.0 |
0.0 |
0.0 |
24 h maximum average score (including area affected & discharge of conjunctivae, total max. 110) |
0 (max 80) |
0 (max 10) |
1.3 (max. 20) |
|
Reversibility |
- |
- |
complete |
complete |
Discharge of conjunctivae average score 0.0 (all readings) |
Reversibility*: No data, as animals were sacrificed due to severity of ocular reactions 24 h after instillation.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The undiluted test substance causes serious damage of the eye (corrosion) even after a short exposure period od 4 s (washed eyes). This result corresponds to the effects of formaldehyde, the hydrolysis product of the test substance. The 0.2% solution is not irritant.
- Executive summary:
Study comparable to OECD guideline 405 with some restrictions but study acceptable for assessment of eye irritant effects. 0.1 mL undiluted test substance instilled into the conjunctival sac of 3 rabbits; eyes unwashed or washed 4 s after application. Readings after 24 h. Same experiments with 0.2% test substance in water.
The undiluted test item is corrosive to eyes. Effects are expected to be permanent.
The 0.2% solution is not irritating.
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