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EC number: 228-705-0 | CAS number: 6330-25-2
- 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
- Study period:
- 1981-06-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted without GLP compliance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Fed.Reg.38, No.187, Para.1500.42, S.27019 (1973-09-27)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-cyano-N-methylacetamide
- EC Number:
- 228-705-0
- EC Name:
- 2-cyano-N-methylacetamide
- Cas Number:
- 6330-25-2
- Molecular formula:
- C4H6N2O
- IUPAC Name:
- 2-cyano-N-methylacetamide
- Details on test material:
- - Name of test material: N-Methylcyanacetamid
- Physical state: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Firma Gaukler, Offenbach / Main
- Weight at study initiation: male: 2.99 kg / female: 2.43 kg
- Housing: Stainless steel cage with wire shelves, ground area: 40 x 51 cm
- Diet (ca. 130 g/animal): Ovator Solikanin 4mm, Muskator-Werke Düsseldorf
- Water (ca. 250 mL/animal): VE-water on week days, tapwater on holidays
- Acclimation period: about 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): ca. 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- ca. 50 mg of crushed substance
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL bulk volume - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 10 d
- Number of animals or in vitro replicates:
- 6 (2 male, 4 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not performed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Primary Irritation Index
- Basis:
- other: Sum of all single stimulus values
- Time point:
- other: 24, 48, 72 h
- Score:
- 16
- Reversibility:
- not fully reversible within: 10 days
- Remarks on result:
- other: two of six animals still showed grade 1 redness of conjunctivae at the last observation day (day 10).
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 1.6
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 10 days
- Remarks on result:
- other: expected to be reversible within 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72h
- Irritant / corrosive response data:
- Ciliary injection as well as a slight opacity of the cornea (three quarters of the area) and significant redness, slight swelling and secretion of the conjunctiva was recorded 24 h after test substance application. In one animal contraction of the pupils was observed after 24 h and 48 h. At day 10 no symptons were recorded.
- Other effects:
- No other effects are reported.
Any other information on results incl. tables
Table 1: Results of the eye irritation test
(FED. REG. 38, NO. 187, PARA. 1500.42, S. 27019 - 1973 -09 -273) |
|||||||||||
Animal |
1 |
2 |
3 |
4 |
5 |
6 |
|||||
Animal number |
0383 |
0371 |
0361 |
0337 |
0365 |
0292 |
|||||
Animal weight (kg) |
2.37 |
2.50 |
2.40 |
3.05 |
2.45 |
2. 92 |
|||||
Sex |
female |
female |
female |
male |
female |
male |
|||||
|
|||||||||||
Time |
Animal |
Cornea |
Iris |
Conjunctiva |
Symptoms |
Single stimulus value |
|||||
TR |
FL |
RO |
SW |
SE |
|||||||
24 h |
1 |
1 |
4 |
1 |
2 |
1 |
1 |
Contraction of the pupils |
|
33 |
|
2 |
0 |
0 |
0 |
2 |
1 |
1 |
|
8 |
|||
3 |
1 |
4 |
1 |
2 |
1 |
2 |
|
35 |
|||
4 |
0 |
0 |
0 |
1 |
0 |
1 |
|
4 |
|||
5 |
1 |
4 |
0 |
2 |
1 |
1 |
|
28 |
|||
6 |
1 |
4 |
1 |
2 |
1 |
1 |
|
|
33 |
||
48 h |
|
|
|
|
|
|
|
|
Mean Value |
24 |
|
1 |
1 |
2 |
1 |
2 |
1 |
1 |
Contraction of the pupils |
|
23 |
||
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 |
|||
3 |
1 |
3 |
1 |
2 |
1 |
1 |
|
28 |
|||
4 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
|||
5 |
1 |
2 |
0 |
2 |
1 |
1 |
|
18 |
|||
6 |
1 |
4 |
1 |
2 |
1 |
1 |
|
|
33 |
||
72 h |
|
|
|
|
|
|
|
|
Mean Value |
17 |
|
1 |
1 |
2 |
0 |
1 |
0 |
0 |
|
12 |
|||
2 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
|||
3 |
1 |
2 |
0 |
1 |
0 |
0 |
|
12 |
|||
4 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
|||
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 |
|||
6 |
1 |
2 |
0 |
1 |
0 |
0 |
|
|
12 |
||
10 d |
|
|
|
|
|
|
|
|
Mean Value |
7 |
|
1 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
|||
2 |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 |
|||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 |
|||
4 |
0 |
0 |
0 |
1 |
0 |
0 |
|
2 |
|||
5 |
0 |
0 |
0 |
0 |
0 |
0 |
|
0 |
|||
6 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
0 |
||
|
|
|
|
|
|
|
|
|
Mean Value |
1 |
|
285 / 18 = 16 (rounded) |
|||||||||||
Primary Irritation Index: 16 |
Explanation of the rating scale:
a) Conjunctiva - Swelling and Cornea - Opacity:
0 - non-existent / 1 - slight / 2 - significant / 3 - severe / 4 - strong
b) Conjunctiva - Redness:
0 - ordinary / 1 - slightly increased / 2 - significant / 3 - severe
c) Iris:
1 - Ciliary injection / 2 - Iritis
d) Cornea - affected area
1 - >= 0, < 1/4
2 - >= 1/4, < 1/2
3 - > = 1/2, < 3/4
4 - >= 3/4
e) Secretion:
0 - ordinary / 1 - slightly increased / 2 - significantly increased / 3 - proliferated
Calculation of the Primary Irritation Index:
A = 5 x Opacity x Area
B = 5 x Iris
C = 2 x (Redness + Swelling + Secretion)
Single Stimulus Value = A + B + C (1 animal per time)
The Primary Irritation Index is the sum of all single stimulus values of all animals and time points (24, 48 and 72 h) divided by 3 x the number of animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The test substance 2 -cyano-N-methylacetamide was investigated for its potential to cause irritation in a rabbit eye according to Fed.Reg.38, No.187, Para.1500.42, S.27019 (1973) with one single application. About 50 mg of crushed substance (bulk volume of 0.1 mL) was applied into the conjunctival sac and not washed out afterwards. The untreated eye served as negative control. 6 animals (2 males and 4 females) were observed for 10 days after this procedure. Ciliary injection as well as a slight opacity of the cornea (three quarters of the area) and significant redness, slight swelling and secretion of the conjunctiva was recorded 24 h after test substance application. In one animal contraction of the pupils was observed after 24 h and 48 h. At day 10 no symptons were recorded. The Primary Irritation Index was calculated according to the scheme of Draize (1965), resulting in a value of 16, which corresponds to a slightly irritating test substance for the rabbit eye mucosa.
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