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EC number: 268-734-6 | CAS number: 68134-22-5
- 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 test material is not irritating to skin under test conditions. The test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin).
The test material was not irritating to eyes in all animals under test conditions, which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. Therefore, it is concluded that the submission substance is not irritating to 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:
- From 26 AUG 1976 to 16 SEP 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: FDA guideline (minor deviations from OECD guideline)
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guideline (Federal Register 38, NO. 187, 27.9.1973, p 27019)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study was performed previous to GLP implementation
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- weight at study initiation: 1.5- 2.0 kg
- Housing: single
- Diet: ERKA 8300, Robert Koch oHG/ Hamm, Germany, ad libitum
- Water: tap water ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped intact and clipped scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- 24 h
- Observation period:
- 48 h after removal of patch with observation time points immediately after removal, 24 and 48 h later.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: erythema and edema scores ranging from 0-4.
Skin was evaluated immediately, 24 h and 48 h after after removal of the patch. Mean values of the readings 24 and 48 h after removal are reported in the results table. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Remarks on result:
- other: clipped intact and clipped scarified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Remarks on result:
- other: clipped intact and clipped scarified
- Irritant / corrosive response data:
- Immediately after removal of patch no erythema score could be determined due to coloration of the skin, no edema was detectable at the end of the exposure duration (score 0). No erythema or edema were detectable at any later time point.
Results with scarified skin were the same. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not irritating to skin under these test conditions.
This conclusion is legitimate even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements. - Executive summary:
The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Immediately after removal of patch no erythema score could be determined due to pigment overlay. No erythema were seen at the later observation time points. No edema were seen at any time point (score 0). The test item is not irritating under these test conditions.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 26 AUG 1976 to 16 SEP 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: FDA guideline (minor deviations from OECD guideline)
- Justification for type of information:
- See read acrodd justification document in chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guideline (Federal Register 38, NO. 187, 27.9.1973, p 27019)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study was performed previous to GLP implementation
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- weight at study initiation: 1.5- 2.0 kg
- Housing: single
- Diet: ERKA 8300, Robert Koch oHG/ Hamm, Germany, ad libitum
- Water: tap water ad libitum - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped intact and clipped scarified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- 24 h
- Observation period:
- 48 h after removal of patch with observation time points immediately after removal, 24 and 48 h later.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: erythema and edema scores ranging from 0-4.
Skin was evaluated immediately, 24 h and 48 h after after removal of the patch. Mean values of the readings 24 and 48 h after removal are reported in the results table. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Remarks on result:
- other: clipped intact and clipped scarified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Remarks on result:
- other: clipped intact and clipped scarified
- Irritant / corrosive response data:
- Immediately after removal of patch no erythema score could be determined due to coloration of the skin, no edema was detectable at the end of the exposure duration (score 0). No erythema or edema were detectable at any later time point.
Results with scarified skin were the same. - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material is not irritating to skin under these test conditions.
This conclusion is legitimate even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements. - Executive summary:
The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Immediately after removal of patch no erythema score could be determined due to pigment overlay. No erythema were seen at the later observation time points. No edema were seen at any time point (score 0). The test item is not irritating under these test conditions.
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:
- key study
- Study period:
- From 26 AUG 1976 to 16 SEP 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: FDA guideline, similar to OECD 405.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guideline (Federal Register Vol. 38, nr. 187, p. 27019, 1973)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study was performed previous to GLP implementation
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: single
- Diet: ERKA 8300, Robert Koch oHG/ Hamm, Germany, ad libitum
- Water: tap water ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg - Duration of treatment / exposure:
- 24 h after exposure eyes were washed with physiological saline.
- Observation period (in vivo):
- 72 h with observation time points at 1, 7, 24, 48 and 72 h after application.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: loupe / fluorescein (for 24 and 48 h reading) - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #3 and #4 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2 and #5 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: the shortened observation period of 72 h
- Remarks on result:
- other: considered to be reversible within a prolonged observation period of 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #1, #2, #3, #4 and #5 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: the shortened observation period of 72 h
- Remarks on result:
- other: considered to be reversible within a prolonged observation period of 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Irritant / corrosive response data:
- individual data for animal #1, #2, #3, #4, #5 and #6 after 1h / 7h / 24h / 48h / and 72h
cornea score: 1/1/1/0/0, 1/1/0/0/0, 2/1/1/0/0, 1/1/1/0/0, 0/0/0/0/0, 1/1/1/1/1
iris score: 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0
conjunctivae redness: 1/1/0/0/0, 0/0/0/0/0, 1/0/0/0/0, 1/1/0/0/0, 1/0/0/0/0, 0/1/1/1/1
conjunctivae chemosis: 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/1/0/0/0 - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was not irritating to eyes in all animals under test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. Therefore, it is concluded that the submission substance is not irritating to eyes.
- Executive summary:
Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. No iridial effects were observed in any animal, and only 1/6 animals had a chemosis score of 1 in the 7 h reading which was completely reversible within 24 h. Slight to moderate corneal effects were visible in 5/6 animals. Apart from 1 animal these effects were completely reversible within the observation time. Conjunctivae redness was observed in 4/6 animals, the effect was also reversible within 72 h for all animals apart from one. It can be concluded that a longer observation period would have resulted in a complete reversibility.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 26 AUG 1976 to 16 SEP 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: FDA guideline, similar to OECD 405.
- Justification for type of information:
- See read across justification document in chapter 13
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: FDA guideline (Federal Register Vol. 38, nr. 187, p. 27019, 1973)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study was performed previous to GLP implementation
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: single
- Diet: ERKA 8300, Robert Koch oHG/ Hamm, Germany, ad libitum
- Water: tap water ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg - Duration of treatment / exposure:
- 24 h after exposure eyes were washed with physiological saline.
- Observation period (in vivo):
- 72 h with observation time points at 1, 7, 24, 48 and 72 h after application.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: loupe / fluorescein (for 24 and 48 h reading) - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #3 and #4 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2 and #5 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: the shortened observation period of 72 h
- Remarks on result:
- other: considered to be reversible within a prolonged observation period of 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #1, #2, #3, #4 and #5 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: the shortened observation period of 72 h
- Remarks on result:
- other: considered to be reversible within a prolonged observation period of 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Irritant / corrosive response data:
- individual data for animal #1, #2, #3, #4, #5 and #6 after 1h / 7h / 24h / 48h / and 72h
cornea score: 1/1/1/0/0, 1/1/0/0/0, 2/1/1/0/0, 1/1/1/0/0, 0/0/0/0/0, 1/1/1/1/1
iris score: 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0
conjunctivae redness: 1/1/0/0/0, 0/0/0/0/0, 1/0/0/0/0, 1/1/0/0/0, 1/0/0/0/0, 0/1/1/1/1
conjunctivae chemosis: 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/0/0/0/0, 0/1/0/0/0 - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was not irritating to eyes in all animals under test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. Therefore, it is concluded that the submission substance is not irritating to eyes.
- Executive summary:
Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. No iridial effects were observed in any animal, and only 1/6 animals had a chemosis score of 1 in the 7 h reading which was completely reversible within 24 h. Slight to moderate corneal effects were visible in 5/6 animals. Apart from 1 animal these effects were completely reversible within the observation time. Conjunctivae redness was observed in 4/6 animals, the effect was also reversible within 72 h for all animals apart from one. It can be concluded that a longer observation period would have resulted in a complete reversibility.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No classification
No irritant effects were detected in vivo on skin and eyes of rabbits.
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.