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EC number: 209-939-2 | CAS number: 598-55-0
- 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:
- From May 04, 1982 to May 18, 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to method equivalent to OECD Guideline 405, in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl carbamate
- EC Number:
- 209-939-2
- EC Name:
- Methyl carbamate
- Cas Number:
- 598-55-0
- Molecular formula:
- C2H5NO2
- IUPAC Name:
- methyl carbamate
- Test material form:
- other: solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Douglassville, Pennsylvania
- Weight at study initiation: 2 - 3 Kg
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care andUse of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet: Wayne rabbit ration, ad libitum
- Water: Fresh tap water, ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C±3°C
- Humidity (%): 30 to 70%
- Photoperiod: 12 h dark and 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST SUBSTANCE
- Amount(s) applied: 100 mg
VEHICLE
No vehicle - Duration of treatment / exposure:
- 14 d
- Observation period (in vivo):
- 1, 24, 48, 72 h, 7 and 14 d after treatment
- Number of animals or in vitro replicates:
- 3/sex/dose
- Details on study design:
- 24 h prior to the application of the test substance, the eyes of the rabbits were examined using 2% sodium fluorescein stain. Animals showing preexisting corneal injury were eliminated from the study. The test substance was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball (conjunctival cul-de-sac) to form a cup. The upper and lower lids were then gently held together for one second to prevent loss of substance. The contralateral eye remained untreated and served as a control.
SCORING SYSTEM:
An animal exhibited a positive reaction when the test substance produced one or more of the following signs:
- ulceration of the cornea (other than a fine stippling)
- opacity of the cornea (other than a slight dulling of the normal luster)
- inflammation of the iris (other than a slight deepening of the rugae or a light hyperemia of the circumcorneal blood vessels)
- an obvious swelling in the conjunctivae (excluding the cornea and iris) with partial eversion of the eyelids
- a diffuse crimson color with individual vessels not easily discernible
GRADING
Grading of irritation is according to the Draize's method.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 13.3
- Max. score:
- 80
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of cornea score at 24, 48 and 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 20
- Max. score:
- 80
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of cornea score at 24, 48 and 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 20
- Max. score:
- 80
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: Based on mean of cornea score at 24 ,48 and 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: 24-72 h
- Score:
- 13.3
- Max. score:
- 80
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of cornea score at 24, 48 and 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- other: 24-72 h
- Score:
- 13.3
- Max. score:
- 80
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of cornea score at 24, 48 and 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- other: 24-72 h
- Score:
- 26.6
- Max. score:
- 80
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: Based on mean of cornea score at 24, 48 and 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of iris score at 24, 48 and 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of iris score at 24, 48 and 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 6.7
- Max. score:
- 10
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: Based on mean of iris score at 24, 48 and 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: 24-72 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of iris score at 24, 48 and 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- other: 24-72 h
- Score:
- 3.3
- Max. score:
- 10
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of iris score at 24, 48 and 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- other: 24-72 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of iris score at 24, 48 and 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 7.3
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of conjunctivae score at 24, 48 and 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 48-72 h
- Score:
- 10.7
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of conjunctivae score at 24, 48 and 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 12
- Max. score:
- 20
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: Based on mean of conjunctivae score at 24, 48 and 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24-72 h
- Score:
- 6
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of conjunctivae score at 24, 48 and 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 7 d
- Score:
- 8
- Max. score:
- 20
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- other: Based on mean of conjunctivae score at 24, 48 and 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 24-72 h
- Score:
- 7.3
- Max. score:
- 20
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: Based on mean of conjunctivae score at 24, 48 and 72 h
- Irritant / corrosive response data:
- At 1, 24 and 48 h after treatment: Positive ocular responses were observed in every rabbit.
At 72 h after treatment: Positive ocular responses were observed in 5 out of 6 rabbits.
On Day 7 after treatment: Positive ocular responses were observed in 2 out of 6 rabbits.
On Day 14 after treatment: No positive occular response was observed.
25 positive scores were recorded during the course of the study.
Any other information on results incl. tables
Table 1: Body weights at start and end of study
Animal number |
Sex |
Test substance |
Initial weight (Kg) |
Final weight (Kg) |
1579 |
Male |
1000 mg per eye |
2.100 |
2.280 |
1580 |
Male |
2.331 |
2.470 |
|
1581 |
Male |
2.296 |
2.047 |
|
1582 |
Female |
2.055 |
2.164 |
|
1583 |
Female |
2.248 |
2.050 |
|
1584 |
Female |
2.776 |
2.959 |
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In acute eye irritation test in rabbits, test substance was determined to be an eye irritant.
- Executive summary:
A study was conducted to evaluate the irritant potential of the test substance on rabbit eye by a method equivalent to OECD Guideline 405, in compliance with GLP. 100 mg of undiluted test substance was administered in one of the eye of three males and three females. 24 h prior to administration, eyes were examined for any preexisting corneal injury using 2% sodium fluorescein stain. The test substance was placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the substance. The other eye, which remains untreated, serves as a control. The eyes were examined at 1, 24, 48 and 72 h and 7 and 14 d after treatment and ocular scoring was done according to Draize’s method. Positive ocular responses were observed in every rabbit at 1, 24, and 48 h after treatment. Positive ocular responses were also observed in five of six rabbits at 72 h after treatment. Two animals had positive ocular responses on Day 7. No positive scores were recorded on Day 14. Twenty-five positive scores were recorded during the study. Under the study conditions, test substance was determined to be an eye irritant (Mallory VT, 1982).
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