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EC number: 253-039-2 | CAS number: 36443-68-2
- 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
Endpoint summary
Administrative data
Description of key information
The substance caused no signs of irritation on rabbit skin and in rabbit eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22.10.1979 to 12.11.1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- light/dark cycle, observation times, exposure time and the use of both intact and abraded skin.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Limited (Toxicology GU 2.1)
- Weight at study initiation: 2 to 3 kgs
- Housing: Individually in metal cages
- Diet: ad libitum standard rabbit food NAFAG No. 814
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Photoperiod (hrs dark / hrs light): 14 hrs dark/ 10 hrs light - Type of coverage:
- occlusive
- Preparation of test site:
- other: Abraded and intact shaved
- Vehicle:
- other: Propylene glycol and saline (70:30)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 50%
- amount: 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 X 2.5 cm
- Type of wrap if used: impermeable material
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
SCORING SYSTEM:
Erythema and eschar formation
No erythema = 0
Very slight erythema (barely perceptible) = 1
Well defined erythema = 2
Moderate to severe erythema = 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4
Total possible erythema score = 4
Edema formation
No edema = 0
Very slight edema (barely perceptible) = 1
Slight edema (edges of area well defined bydefinite raising) = 2
Moderate edema (raised approximately 1 mm) = 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) = 4
Total possible edema score = 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: for both intact and abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: values for both intact and abraded skin
- Irritant / corrosive response data:
- No erythema or edema was observed on any of the test animals on abraded or intact skin.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present experiment the test article was found to cause no irritation when applied to intact and abraded rabbit skin.
- Executive summary:
In a skin irritation study predating GLP the test substance was investigated for dermal effects in rabbits in a test similar to OECD testing guideline 404. An amount of 0.5 g test material was applied to the skin of 3 male and 3 female adult New Zealand White rabbits in an occlusive manner. The protocol differed by additional testing of abraded skin versus intact skin and a prolonged exposure time of 24h was used. Observation was terminated after 7 days which is acceptable as no indication of erythema or erythema was observed during the observation period. All scores for edema and erythema were zero at any time point. Based on the results of this study, the test article is considered to be not irritating to the rabbit skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.8.1979 to 12.11.1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- light/dark cycle; flushing of 3 of the rabbits' eyes after exposure.
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 163.81-4 "Primary eye irritation study"
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Limited
- Weight at study initiation: 2 to 3 kgs
- Housing: Individually in metal cages
- Diet: ad libitum standard rabbit food NAFAG No. 814
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10%
- Photoperiod (hrs dark / hrs light): 14 hrs dark/ 10 hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- In 3 of 6 rabbits the test substance was flushed with 10 mL of saline after 30 seconds of exposure, the other 3 rabbits did not have their eye flushed. The right eye of each rabbit served as the control.
- Observation period (in vivo):
- Observations were taken on day 1,2,3,4, and 7.
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Flushing with 10 mL of saline in 3 of the rabbits' eyes
- Time after start of exposure: Washing occurred 30 seconds after exposure
SCORING SYSTEM:
Score for eye irritation in rabbits (Table 1)
CORNEA:
A Opacity and degree of density (most dense eurea scored)
No opacity = 0
Scattered or diffuse area, details of iris clearly visible = 1
Easily discernible translucent areas, details of iris slightly obscured = 2
Opalescent areas, no detiails of iris visible, size of pupil barely discernible = 3
Opaque, iris invisible = 4
B Area of cornea involved
One quarter (or less) but not zero = 1
Greater than one quarter, but less than half = 2
Greater than half, but less than three quarters = 3
Greater than three quarters, up to whole area = 4
Calculation of Score: A X B X 5
Maximum possible score = 80
IRIS
A Values
Normal = 0
Folds above normal, congestion, swelling, circumcornea injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive = 1
No reaction to light, hemorrhage, gross destruction (any or all of these) = 2
Calculation of score: A X 5
Maximum possible score « 10
CONJUNCTIVAE:
A Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal = 0
Vessels definitely injected cibove normal = 1
More diffuse, deeper crimson red, individual vessels not easily discernible = 2
Diffuse beefy red = 3
B Chemosis
No swelling = 0
Any swelling eibove normal (Includes nictitating membrane) = 1
Obvious swelling with partial eversion of lids = 2
Swelling with lids about half closed = 3
Swelling with lids about half closed to completely closed = 4
C Discharge
No discharge = 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals) = 1
Discharge with moistening of the lids and hairs just adjacent to lids = 2
Discharge with moistening of the lids and hairs, and considerable area around the eye = 3
Calculation of score: (A + B + C) X 2
Maximum possible score » 20
Calculation of the primary eye irritation index:
The mean reaction scores for cornea, iris and conjunctiva observed after 1, 2, 3, 4 and 7 days were summed up and the sum divided by 5. This procedure was carried out separately for unrinsed (A) and rinsed (B) eyes respectively.
Index
0 - 1 0 = Minimal
11 - 25 = Slight
26 - 55 = Moderate
56 - 84 = Marked
above 84 = Extreme
The ratio R = A : B indicates the effect of rinsing the eyes approximately 30 seconds after instillation of the compound.
If R is
<1 rinsing increased the effect of the compound
= 1 no effect
= 1.1 - 1.5 practically no effect
= 1.6 - 2 little but assessable effect
= 2.1 - 4 good effect
= 4.1 - 10 very good effect
>10 action of the compound practically abolished
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- other: rinsed and unrinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: rinsed and unrinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: rinsed and unrinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: rinsed and unrinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: rinsed and unrinsed
- Irritant / corrosive response data:
- No irritation
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
The substance was investigated for skin irritation in rabbits in a test similar to OECD testing guideline 404 predating GLP but with adequate reporting details. The protocol differed by additional testing of abraded skin versus intact skin and a prolonged exposure time of 24h was used. Observation was terminated after 7 days which is acceptable as no indication of erythema or erythema was observed during the observation period.
Eye irritation
The study on eye irritation followed the procedure of OECD testing guideline 405 predating GLP but with adequate reporting details. An additional number of animals for which the eyes were rinsed immediately after substance application. Observation was terminated after 7 days. No indication of effects on iris, cornea or conjunctivae was observed for rinsed or unrinsed eyes. No indication of systemic toxicity was recorded.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No. 1272/2008.
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