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EC number: 249-881-5 | CAS number: 29820-13-1
- 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
CaTG is not irritating to the skin, but is considered irritating to eyes (Eye Irrit 2).
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:
- 04-Mar-2003 - 09-Mar-2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- French Republic, Prime Minister, Interministerial Group on Chemicals (GIPC)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age/weight: on the day of treatment, the animals were 2 to 4 months old and had a mean body weight ± standard deviation of 2.6 ± 0.2 kg.
- Food and water: ad libitum
- Acclimation: at least 5 days before the beginning of the study.
ENVIRONMENTAL CONDITIONS
- temperature: 18 ± 3°C
- relative humidity: 30 to 70%
- light/dark cycle: 12 h/12 h
- ventilation: approximately 12 cycles/hour of filtered, non-recycled air. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Doses of 500 mg of the test item were placed on a dry gauze pad which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animals. The gauze pad was used dry and not moistened with water because the pH of the test item in water is 12. The OECD Guideline No. 404 recommends to use water or another suitable vehicle (if necessary) to moisten the test item and ensure a good contact with the skin. However, as the skin of the rabbit may be sensitive to many vehicles, it was chosen not to use a moistening agent rather than a non well-tolerated vehicle (such as corn oil). Furthermore, this condition of application reflects more accurately the condition of a possible accidental exposure.
- Duration of treatment / exposure:
- As possible irritant effects were anticipated, the test item was evaluated on a single animal in the first instance. The duration of exposure was 3 minutes on one flank and 4 hours on the other flank.
Since the test item was not severely irritant on this first animal, it was then applied for 4 hours to two other animals. - Observation period:
- The skin was examined approximately 1, 24, 48 and 72 hour(s) after removal of the dressing.
Since there was persistent irritation reactions at 72 hours, the observation period was extended. In the absence of complete reversibility of skin reactions on day 15, the study was ended. - Number of animals:
- 3
- Irritation parameter:
- erythema score
- Remarks:
- 3-minute exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: dryness of the skin on day 1 and 2
- Irritation parameter:
- edema score
- Remarks:
- 3-minute exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: dryness of the skin on day 1 and 2
- Irritation parameter:
- erythema score
- Remarks:
- 4 -hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- 4 -hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- 4 -hour exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- 4 -hour exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- 4 -hour exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: Day 7
- Remarks on result:
- other: Residual test item
- Irritation parameter:
- edema score
- Remarks:
- 4 -hour exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: Day 7
- Remarks on result:
- other: Residual test item
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, the test item CaTG is not irritating when applied topically to rabbits.
- Executive summary:
After a 3-minute exposure (one animal), a very slight erythema (grade 1) was noted from day 1 up to day 4. Dryness of the skin was recorded on day 2 and 3 then between day 5 and day 10.
After a 4-hour exposure (three animals), a very slight or well-defined erythema (grade 1 or 2), together with a very slight oedema (grade 1) between day 2 and day 5, was noted in 1 of 3 animals from day 2 up to day 7. Dryness of the skin was recorded in the same animal from day 6 up to the end of the observation period (day 15).
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 2.0 for erythema and 0.0, 0.0 and 1.0 for oedema.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 Mar 2003 - 10 July 2003
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- ex vivo study
- Principles of method if other than guideline:
- The rabbit enucleated eye test is used at SPL as a first stage in the assessment of ocular irritancy potential. The preferred species of choice is the rabbit. The assay has undergone interlaboratory validation and has been shown to reliably detect test materials that are negligible, or moderate to severe ocular irritants compared to the OECD 405 guideline study.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Dept. of Health, UK
- Species:
- other: ex vivo rabbit eyes
- Strain:
- not specified
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A volume of 0.1 ml of the test material, which was found to weigh approximately 55 mg (as measured by gently compacting the required volume into an adapted syringe) was sprinkled as evenly as possible over the surface of the cornea. After ten seconds the test material was washed off the cornea using a minimum of 20 ml of saline solution (approximately 32°C). After washing, some of the test material was found to have adhered to the cornea, this did not affect the assessment of irritation or swelling.
- Duration of treatment / exposure:
- Immediately following washing of the corneal surface, the treated eye was returned to the superfusion chamber and the saline drip repositioned to irrigate the eye. The untreated eyes were similarly washed and used for control purposes.
- Observation period (in vivo):
- Assessment of corneal cloudiness was made pre-enucleation, post equilibration and approximately 60, 120, 180 and 240 minutes following treatment, according to the numerical evaluation adopted from Advances in Modern Toxicology: Dermatoxicology, 4th Ed, (F Marzulli and H Maibach, eds) Hemisphere Publishing Corporation, Washington DC, 1991, pp 749-815.
- Number of animals or in vitro replicates:
- Three eyes were treated with test material, two additional eyes remained untreated for control purposes. The treatment eye was removed from thesuperfusion apparatus whilst still being held in the perspex clamp. The clamp/eye was then placed horizontally into a petri dish.
- Irritation parameter:
- cornea opacity score
- Value:
- 0
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Irritation parameter:
- other: Corneal Epithelium Condition
- Value:
- 0
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Other effects / acceptance of results:
- Corneal Opacity: No corneal effects were noted in the test eyes or control eyes during the study period.
Corneal thickness and Condition: Corneal swelling of the test eyes during the study period was slightly greater than that observed in the control eyes over the same period. The condition of the corneal epithelium of the test eyes and control eyes appeared normal during the study period.
Fluorescein Uptake: No fluorescein uptake was noted in the test eyes or control eyes 240 minutes after treatment. - Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the conditions of the test and following assessment of data for all end points, the test material is considered to have the potential to cause ocular irritancy in vivo. The test material is also likely to cause severe ocular irritancy in vivo in respect of its extreme alkalinity in aqueous solution.
- Executive summary:
A screening study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test material in man.
For that purpose 0.1 ml of the test material, which was found to weigh approximately 55 mg, was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32°C ± 1.5°C within a superfusion chamber. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% Sodium Chloride).
Maximal ocular irritation observations recorded for the test eyes were as follows:
Corneal Opacity
Fluorescein Uptake
Corneal Swelling (%)
Condition of Corneal Epithelium
Test Eyes a [min]
Control Eyes b [min]
Cldy
Area
Int
Area
60
120
240
60
120
240
0
0
0
0
11.2
12.5
20.0
3.4
3.6
3.7
Normal
a = For each time point the swelling recorded is the mean of three eyes
b = For each time point the swelling recorded is the mean of two eyes
Cldy = Corneal cloudiness
Int = Intensity of fluorescein uptake
[min] = Minutes following treatment
It can be concluded that under the conditions of the test, the test material is considered to have the potential to cause ocular irritancy in-vivo. The test material is also likely to cause severe ocular irritancy in-vivo in respect of its extreme alkalinity in aqueous solution.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Effects on skin irritation/corrosion:
not irritating
Effects on eye irritation: irritating (Eye Irrit 2)
Justification for classification or non-classification
Based on the irritating properties of CaTG, CaTG should be classified as follows:
EU GHS:
Eye Irrit. 2; H319: Causes serious eye irritation.
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