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EC number: 203-419-9 | CAS number: 106-65-0
- 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
Endpoint summary
Administrative data
Description of key information
Skin: Not irritating (OECD 404 / EU Annex V method B4)
Eye: Not irritating (OECD 405 / EU Annex V method B5)
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:
- weight of evidence
- Study period:
- July 1990 - February 1991
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.0 - 4.2 kg
- Housing: Metal cages
- Diet (e.g. ad libitum): Altromin 2123 rabbit diet, ad-libitum
- Water (e.g. ad libitum): Deionised water, ad-libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 deg C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 1990-07-24 To: 1990-07-27 - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100% (undiluted) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm square
- % coverage: 100% over stated area
- Type of wrap if used: Fabric wound plaster held in place by semi-occlusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual material removed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to Draize et.al as described in OECD test guideline - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- None observed
- Other effects:
- None observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the skin
- Executive summary:
Potential irritation / corrosion following a single application to the intact skin of rabbits has been investigated. Methods followed those described by OECD Test Guideline No. 404 and EC Directive 84/449/EEC, B.4. A 0.5 mL aliquot of the substance was applied to a site of approximately 2.5 cm x 2.5 cm area of intact skin on each of 3 rabbits and covered by semi-occlusive dressing. The duration of the exposure was 4 hours. The treated skin was examined: 0.5-1, 24, 48 and 72 hours after exposure for evidence of reaction to treatment.
No effects of treatment were observed.
The substance is not irritating to the skin
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- February 1999 - July 1999
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: J. Schitkovits, 2620 Natschbach, Austria
- Weight at study initiation: 2.6 - 2.7 kg
- Housing: Individual wire cages, 79x59x35 cm
- Diet (e.g. ad libitum): Altromin 2023 rabbit diet, ad-libitum
- Water (e.g. ad libitum): Tap water, ad-libitum
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20deg C average
- Humidity (%): 54% average
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: 1999-04-27 To: 1999-04-30 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100% (undiluted) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm square
- % coverage: 100% over stated area
- Type of wrap if used: Cellulose patch held in place by "Blenderm" hypoallergenic surgical tape overlain by self adhesive non-woven fabric
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual material removed with wet Kleenex tissues
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to Draize et.al as described in OECD test guideline - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- None observed
- Other effects:
- None observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the skin
- Executive summary:
Potential irritation / corrosion following a single application to the intact skin of rabbits has been investigated. Methods followed those described by OECD Test Guideline No. 404 and EC Directive 92/69/EEC, B.4. A 0.5 mL aliquot of the substance was applied to a site of approximately 2.5 cm x 2.5 cm area of intact skin on each of 3 rabbits and covered by semi-occlusive dressing. The duration of the exposure was 4 hours. The treated skin was examined 1, 24, 48 and 72 hours after exposure for evidence of reaction to treatment.
No effects of treatment were observed.
The substance is not irritating to the skin
Referenceopen allclose all
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:
- weight of evidence
- Study period:
- July 1990 - August 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.2 - 4.0 kg
- Housing: Metal cages
- Diet (e.g. ad libitum): Altromin 2123 rabbit diet, ad-libitum
- Water (e.g. ad libitum): Deionised water, ad-libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 deg C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 1990-07-31 To: 1990-08-07 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100% (undiluted) - Duration of treatment / exposure:
- Exposure at a single time point
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours with physiological saline at 37 deg C
SCORING SYSTEM: Accoding to Draize et.al. as described by the OECD test method
TOOL USED TO ASSESS SCORE: fluorescein - slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Corneal opacity: In 2/3 animals corneal abnormalities were noted. Diffuse areas of opacity (score "1") were noted. In 1/3 animals easily discernible translucent areas (score of "2) with the whole cornea affected. The lesions were fully reversible after 7 days.
Iris inflammation: In 3/3 animals mild changes (score "1") were noted from 1 hour and remained for at least 72 hours.
Conjunctival redness: diffuse crimson colour to a diffuse beefy red (scores "2" and "3") were noted in all animals. The lesions were observed from 1 hour and remained for at least 72 hours. Recovery had occurred within 7 days.
Conjunctival chemosis: Significant swelling with a score of "3" was observed in 3/3 animals after 1 hour. In 2/3 animals swellings in different degrees of severity (scores "1" to "3") were noted from 24 - 72 hours. The lesions then gradually returned to normal and after 7 days no swelling was detectable. - Other effects:
- None observed
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The substance is irritating to the eye
- Executive summary:
The potential irritating / corrosive effects following a single administration into the eye of rabbits has been investigated. Methods followed those described in OECD Test Guideline No. 405 and EC Directive 92/69/EEC B.5. A 0.1 mL aliquot was instilled into the conjunctival sac of one eye of each of 3 rabbits. The treated eyes were examined 1, 24, 48 and 72 hours and 7 days following exposure.
In all 3 animals reversible corneal lesions (scattered areas of opacity) were observed, present for at least 72 hours in 2 of the 3 animals. In all animals the iris was mildly injected for up to 72 hours after exposure. Well defined to marked redness of the conjunctivae was observed in all 3 animals after 1 hour and remained for a maximum of 72 hours. Marked chemosis of the conjunctivae was seen in all animals for a maximum of 72 hours post exposure. Complete recovery had occurred within 7 days of exposure.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- February 1999 - July 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: J. Schitkovits, 2620 Natschbach, Austria
- Weight at study initiation: 2.6 - 3.4 kg
- Housing: Individual wire cages 79x59x35 cm
- Diet (e.g. ad libitum): Altromin 2023 rabbit diet, ad-libitum
- Water (e.g. ad libitum): Tap water, ad-libitum
- Acclimation period: At least 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 deg C average
- Humidity (%): 55% average
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
IN-LIFE DATES: From: 1999-04-27 To: 1999-05-07 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100% (undiluted) - Duration of treatment / exposure:
- Exposure at a single time point
- Observation period (in vivo):
- 6 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
SCORING SYSTEM: Accoding to Draize et.al. as described by the OECD test method
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - slit lamp - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Corneal opacity: In 2/3 animals corneal abnormalities were noted. Diffuse areas of opacity (score "1") were noted in 2/3 animals with the whole cornea affected. The lesions were fully reversible after 24 or 72 hours. The cornea of the third animal was normal at all times.
Iris inflammation: In 2/3 animals mild changes (score "1") were noted from 1 hour and remained for a maximum of 72 hours.
Conjunctival redness: Injected blood vessels to a diffuse crimson colour (scores "1" and "2") were noted in all animals. The lesions were observed from 1 hour to a maximum of 72 hours.
Conjunctival chemosis: A slight swelling with a score of "1" was observed in 1/3 animals after 1 hour. In 2/3 animals swellings in different degrees of severity (scores "1" to "3") were noted from 1 hour onwards. The lesions then gradually returned to normal and after 72 hours no swelling was detectable. - Other effects:
- None observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is slightly irritating to the eye
- Executive summary:
The potential irritating / corrosive effects following a single administration into the eye of rabbits has been investigated. Methods followed those described in OECD Test Guideline No. 405 and EC Directive 92/69/EEC B.5. A 0.1 mL aliquot was instilled into the conjunctival sac of one eye of each of 3 rabbits. The treated eyes were examined 1, 24, 48 and 72 hours and 6 days following exposure.
In 2 of the 3 animals reversible corneal lesions (scattered areas of opacity) were observed. In 1 of the 3 animals the iris was mildly injected 24 - 72 hours after exposure and in a second animal 1 hour after exposure. Very slight to pronounced redness of the conjunctivae was observed in all 3 animals after 1 hour and remained for a maximum of 72 hours. Slight to obvious chemosis of the conjunctivae was seen in all animals for a maximum of 48 hours post exposure.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Two tests for acute dermal irritation following 4 hours exposure to intact skin of the rabbit and two eye irritation tests in the rabbit have been undertaken.
Assessment has been based on these critical studies for the end-points.
The skin irritation studies show that the substance is not irritating to the skin. One eye irritation study indicates the substance, while exhibiting some irritation, should not be classified as irritant to the eye. The second study indicates the substance to be irritant. There is a variation in ocular response to the effects of the substance and there is justification for using all the available information, in a weight of evidence approach, by combining the 2 studies to account for the apparent variation. In both EU and GHS classification procedures there are difference in the manner in which the numerical scores asssigned to the severity of observed reaction is calculated, depending on the number of animals for which data are available. The weight of evidence from all the available information indicates that the degree of irritation observed is not of sufficient severity to require classification under either EU or GHS criteria.
Justification for classification or non-classification
Non classification is justified by the following:
In-vivo tests for skin irritation corrosion indicate that the substance is not irritant to the skin.
In-vivo tests for eye irritation indicate that the substance, while causing irritation to the eye, does not cause iritation at an incidence or sufficient severity / duration to require classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.