Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 202-773-1 | CAS number: 99-62-7
- 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 irritation
Skin irritation, guinea pig, 24 h occlusive, slightly irritating
Eye irritation
Eye irritation, rabbit, 8 days, slight eye irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Remarks:
- in vivo study that was performed prior to current requirement for in vitro alternative testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 JUL 1985 - 20 DEC 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 5 guinea pigs were exposed to the test item under occlusive conditions for 24 h.
- GLP compliance:
- not specified
- Species:
- guinea pig
- Strain:
- Hartley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: CRL (HA)BR Hartley
- Weight at study initiation: 435 - 502g - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Undilute as received
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 2 weeks
- Number of animals:
- five (5)
- Details on study design:
- no details given
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- ca. 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal: 1-5
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal: 1-5
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Slight or very slight edema was observed in 1 of 5 and 3 of 5 guinea pigs, respectively, at 24-48 hours after exposure to m-diisopropylbenzene. Edema was accompanied by moderate to severe erythema in 2 of 5 guinea pigs, and well-defined erythema in 2 of 5 guinea pigs. Moderate to severe erythema without edema was observed in 1 of 5 guinea pigs at 24-48 hours after exposure. For all test animals, there were no signs of edema or erythema at 2 weeks after exposure.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article was determined to be slightly irritating. However, the exposure duration was 24 h and not 4 h as by the OECD Test Guideline 404. Thus, this is a clear worst-case result.
- Executive summary:
A skin irritation test in guinea pigs was performed. Slight or very slight edema was observed in 1 of 5 and 3 of 5 guinea pigs, respectively, at 24-48 hours after exposure to the test item. Edema was accompanied by moderate to severe erythema in 2 of 5 guinea pigs, and well-defined erythema in 2 of 5 guinea pigs. Moderate to severe erythema without edema was observed in 1 of 5 guinea pigs at 24-48 hours after exposure. For all test animals, there were no signs of edema or erythema at 2 weeks after exposure. This compound was determined to be slightly irritating. However, the exposure duration was 24 h and not 4 h as by the OECD Test Guideline 404. Thus, this is a clear worst-case result.
Reference
animal no. | finding | skin (post-exposure) | |
24-48 hrs | 2 weeks | ||
1 | erythema | mod-severe | normal |
edema | normal | ||
2 | erythema | well-defined | normal |
edema | very slight | normal | |
3 | erythema | mod-severe | normal |
edema | very slight | normal | |
4 | erythema | mod-severe | normal |
edema | slight | normal | |
5 | erythema | well-defined | normal |
edema | very slight | normal |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Remarks:
- in vivo study that was performed prior to current requirement for in vitro alternative testing
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- in vivo study that was performed prior to current requirement for in vitro alternative testing
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 0.1 mL of undiluted material was applied to each of 2 eyes of 3 rabbits; material was immediately washed from one eye of each rabbit with distilled water.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: New Zealand White
- Weight at study initiation: not determined - Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 mL of undiluted material was applied to each of 2 eyes of 3 rabbits; material was immediately washed from one eye of each rabbit with distilled water
- Duration of treatment / exposure:
- one single application
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): distilled water
- Time after start of exposure: immediate washing was palliative - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- unwashed, washed
- Time point:
- other: 1 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- Slight irritation was observed in the conjunctiva and nicitating membrane of 3 of 3 rabbits at one hour after instillation of 0.1 mL of m-diisopropylbenzene. After 24 hours, irritation was not observed in the conjunctiva and nicitating membrane, but was observed in the eyelids in 3 of 3 rabbits. By 48 hours, there were no signs of ocular irritation in any treated animal. There were no signs of irritation observed in the cornea or iris at any time during the study. The test substance was considered to be a slight eye irritant.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered to be a slight eye irritant, which does not meet the criteria for classification and labelling according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.
- Executive summary:
The eye irritation was tested in three rabbits. Slight irritation was observed in the conjunctiva and nicitating membrane of 3 of 3 rabbits at one hour after instillation of 0.1 mL of test item. After 24 hours, irritation was not observed in the conjunctiva and nicitating membrane, but was observed in the eyelids in 3 of 3 rabbits. By 48 hours, there were no signs of ocular irritation in any treated animal. There were no signs of irritation observed in the cornea or iris at any time during the study. The test substance was considered to be a slight eye irritant, which does not meet the criteria for classification and labelling according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation / corrosion
A skin irritation test in guinea pigs was performed. Slight or very slight edema was observed in 1 of 5 and 3 of 5 guinea pigs, respectively, at 24-48 hours after exposure to test item. Edema was accompanied by moderate to severe erythema in 2 of 5 guinea pigs, and well-defined erythema in 2 of 5 guinea pigs. Moderate to severe erythema without edema was observed in 1 of 5 guinea pigs at 24-48 hours after exposure. For all test animals, there were no signs of edema or erythema at 2 weeks after exposure. This compound was determined to be slightly irritating. However, the exposure duration was 24 h and not 4 h as by the OECD Test Guideline 404. Thus, this is a clear worst-case result.
Eye irritation
Eye irritation was tested in three rabbits. Slight irritation was observed in the conjunctiva and nictitating membrane of 3 of 3 rabbits at one hour after instillation of 0.1 mL of test item. After 24 hours, irritation was not observed in the conjunctiva and nictitating membrane but was observed in the eyelids in 3 of 3 rabbits. By 48 hours, there were no signs of ocular irritation in any treated animal. There were no signs of irritation observed in the cornea or iris at any time during the study. The test substance was considered to be a slight eye irritant.
Justification for classification or non-classification
In two independent studies, the test item produced slight, transient irritation when applied to the skin of guinea pigs, and therefore does not satisfy the criteria for classification as a dermal irritant according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
When instilled into the eye, test item produced mild and transient irritation of the conjunctiva, but no evidence of corneal opacity in rabbits.
Based upon these findings, test item does not satisfy the criteria for classification as an ocular irritant according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008 or UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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.
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