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EC number: 236-102-9 | CAS number: 13162-05-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 7-21, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-vinylformamide
- EC Number:
- 236-102-9
- EC Name:
- N-vinylformamide
- Cas Number:
- 13162-05-5
- Molecular formula:
- C3H5NO
- IUPAC Name:
- N-vinylformamide
- Details on test material:
- - Physical state: Clear pale yellow liquid
- Lot No.: RP-690-11890-1603
- Expiration date of the lot: October 27, 1991
- Analytical purity: 90 - 99%
- Impurities (identity and concentrations): Formamide 1 - 9%
- Storage condition of test material: At -20°C (freezer) in the dark unless stated otherwise
- Stability under storage conditions: stable for 30 days
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 12 weeks
- Weight at study initiation: 2561 - 2923 grams
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- Diet: Standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day
- Water: Tap-water diluted with decalcified water ad libitum
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C (Fluctuations were noted, but were considered not to have affected study integrity)
- Humidity (%): 55% (Fluctuations were noted, but were considered not to have affected study integrity)
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied (volume or weight with unit): 0.1 ml
- Concentration: undiluted - Duration of treatment / exposure:
- unspecified
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- NO REMOVAL OF TEST SUBSTANCE
SCORING SYSTEM:
Cornea
Opacity: degree of density (most dense area taken for reading)
0: No ulceration or opacity
1: Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible
2: Easily discernible translucent area; details of iris slightly obscured
3: Nacrous area; no details of iris visible; size of pupil barely discernible
4: Opaque cornea; iris not discernible through the opacity
Iris
0: Normal
1: Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is considered to be an effect)
2: Hemorrhage, gross destruction, or no reaction to light
Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
0: Normal
1: Some blood vessels hyperaemic (injected)
2: Diffuse, crimson colour; individual vessels not easily discernible
3: Diffuse beefy red
Chemosis
Swelling (refers to lids and/or nictating membranes)
0: Normal
1: Some swelling above normal
2: Obvious swelling, with partial eversion of lids
3: Swelling, with lids about half closed
4: Swelling, with lids more than half closed
Discharge
0: No discharge
1: Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2: Discharge with moistening of the lids and hairs, just adjacent to lids
3: Discharge with moistening of the lids and hairs, in a considerable area around the eye
A Draize score was calculated for each day of observation, using the following formula (Draize et al., J. Pharmacol. Exp. Ther. 82, 1944):
(5x corneal opacity grade x area of opacity grade) + (5x iridial injury grade) + 2x (conjunctival redness grade + chemosis grade + discharge grade)
From the calculated maximum Draize score, a Kay and Calandra interpretation (J. Society of Cosmetic Chemists, Vol. 13 no. 6, 1962) was obtained, using the tables below. As can be seen in the second table, the Kay and Calandra interpretation takes into account the time required for the healing process.
0 - 0.5: Non-irritating (N)
0.5 - 2.5: Practically non-irritating (PN)
2.5 - 15: Minimally irritating (M1)
15 - 25: Mildly irritating (M2)
25 - 50: Moderately irritating (M3)
50 - 80: Severely irritating (S)
80 - 100: Extremely irritating (E)
100 - 110: Maximally irritating (Mx)
For borderline scores choose the higher rating.
Tentative Rating & Requirement for Maintenance:
N: MTS24 = 0; for MTS24 > 0, raise one level.
PN: As for N.
M1: MTS48 = 0; for MTS48 > 0, raise one level.
M2: MTS96 = 0; for MTS96 > 0, raise one level.
M3: (1) MTSf < 20 ; for MTSf > 20, raise one level, (2) ITSf < 10 (60%); if not true then no rabbit may show ITSf > 30; otherwise raise one level.
S: (1) As for M3 except use MTSf < 40, (2) As for M3 except use ITSf < 30 (60%) and 60 for high.
E: (1) As for M3 except use MTSf < 80, (2) As for M3 except use ITSf < 60 (60%) and 100 for high.
Mx: (1) MTSf > 80 (60%); for MTSf < 80, lower one level, (2) ITSf > 60 (60%); otherwise lower one level.
Symbols: MTS = Mean total score, ITS = Individual rabbit score. Subscripts denote scoring interval : 24, 48 or 96 hrs., f=final score (7 days).
TOOL USED TO ASSESS SCORE: hand-slit lamp & fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- Cornea, iris and conjunctivae affected. The injection of the iris had resolved within 7 days in all three animals. The opacity of the cornea and the irritation of the conjunctivae however, had not resolved within the study period (22 days). Grey/white discolouration of the conjunctivae as signs of necrosis was observed in all three animals during the study. Signs of necrosis were still noted on the nictating membrane in animals 3541 and 3542 on day 22. Pannus (neovascularisation of the cornea), corneal opacity (grade 2; animal 3540, grade 1; animals 3541 and 3542) and conjunctival redness and swelling were noted in all three animals on day 22. Corneal opacity was observed throughout the study and no significant decrease was noted on day 22, compared to the observations made earlier in the study. Treatment of the eyes with 2% fluorescein, 24 and 72 hours and 7, 14 and 22 days after test substance instillation revealed corneal epithelial damage in all of the animals. A slow rate of corneal epithelial healing was noted.
- Other effects:
- No staining of peri-ocular tissues by the test substance was observed. No toxic symptoms were observed in the animals during the test period and no mortality occurred.
Any other information on results incl. tables
Calculations for EEC classification:
Animal No. |
Reading time (h) |
Corneal opacity |
Iris lesion |
Conjunctivae |
|
Redness |
Chemosis |
||||
3540 (1) |
24 |
1 |
1 |
3 |
3 |
48 |
1 |
1 |
3 |
2 |
|
72 |
1 |
1 |
3 |
2 |
|
mean |
1 |
1 |
3 |
2.3 |
|
3541 (2) |
24 |
1 |
1 |
3 |
3 |
48 |
1 |
1 |
3 |
3 |
|
72 |
1 |
1 |
3 |
2 |
|
mean |
1 |
1 |
3 |
2.7 |
|
3542 (3) |
24 |
1 |
1 |
3 |
3 |
48 |
1 |
1 |
3 |
3 |
|
72 |
1 |
1 |
3 |
3 |
|
mean |
1 |
1 |
3 |
3 |
Draize scores:
Time after administration |
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
21 d |
Mean total score |
22.3 |
34 |
42.3 |
41 |
38 |
25.3 |
27 |
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Classification: risk of serious damage to eyes
- Conclusions:
- The test substance is severely irritating to the rabbit eye.
- Executive summary:
The study was carried out in accordance with OECD Guideline 405 under GLP conditions.
The undiluted test substance (0.1 ml) was instilled into one eye of each of three female New Zealand White rabbits, followed by seven observations at approximately 1, 24, 48 and 72 hours and 7, 14 and 21 days after test substance administration. Under the conditions of this study, the test substance resulted in adverse effects on the cornea, iris and the conjunctivae. The injection of the iris had resolved within 7 days after instillation, but neither the opacity of the cornea nor the irritation of the conjunctivae had resolved within the study period in the three animals. Signs of necrosis on the conjunctivae were observed in all three animals and were still noted in two animals on day 22. The corneal opacity had been persistent throughout the study and had not decreased significantly on day 22. Neovascularisation of the cornea was noted in all three animal from day 8 onwards. No signs of systemic intoxication were observed during the study period.
Based on the Kay and Calandra interpretation of the calculated maximum Draize score (42.3), the test substance should be considered severely irritating (S) to the rabbit eye. The corneal opacity grades and persistency of the opacities to day 22 were considered to be corrosive effects caused by the test substance.
Conclusions: The test substance is severely irritating to the rabbit eye.
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