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

Eye irritation
Administrative data
- 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
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: dermal
- 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:
- The test was conducted according to an internal method. The following is mentioned: Test SOP No. TA 310, TA 160 and TA 120
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: CRL (HA)BR Hartley
- Weight at study initiation:
Male: 390 - 483g,
Female: 282 - 349g - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- undilute as received
- Duration of exposure:
- 2 weeks
- Doses:
- 20 mL/kg
- No. of animals per sex per dose:
- five (5)
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 20 mL/kg bw
- Based on:
- test mat.
- Clinical signs:
- other: no evidence of percutaneous absorption
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- At most, test item is only slightly toxic by the dermal route. There was no evidence of percutaneous absorption. LD50 value was determined to be greater than 20 mL/kg bw (= ca. 20000 mg/kg bw/d).
- Executive summary:
The acute toxicity to guinea pig in dermal test was performed. At most, test item is only slightly toxic by the dermal route. There was no evidence of percutaneous absorption. LD50 value was determined to be greater than 20mL/kg bw (= ca. 20000 mg/kg bw/d).
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- 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:
- The test was conducted according to an internal method. The test SOP NO. TA 300 and TA 120 are mentioned. The method of calculation was the Weil Method.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- TEST MATERIAL
- name as cited in test report: m-diisopropylbenzene
- Molecular weight: 162 g/mol
- Molecular formula: C12H18
- Physical state: liquid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability with H+; OH-; Heat, Light, H2: given - Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: CRL: CD (SD) BR
- Weight at study initiation:
Male: 136 - 149g,
Female: 143 - 160g - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- undilute as received)
- Details on oral exposure:
- Test article was administered neat via oral gavage
- Doses:
- 1250, 2500, 5000 mg/kg bw
- No. of animals per sex per dose:
- five (5)
- Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths were reported for neither low, mid nor high dose group animals.
- Gross pathology:
- No compound-related effects were observed at gross pathology examination of the high-dose group of animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No compound-related effects were observed at gross pathology examination of the high-dose group of animals. The compound was considered to be slightly toxic following oral administration. The LD50 value was greater than 5000 mg/kg body weight.
- Executive summary:
The acute toxicity to rats in oral gavage test was performed. No compound-related effects were observed at gross pathology examination of the high-dose group of animals. The compound was considered to be - at most - slightly toxic following oral administration. The LD50 value was greater than 5000 mg/kg body weight.
"At most, slightly toxic orally. No compound-related effects were observed at gross pathlogy examination of the high-dose group of animals."
LD50 (males) > 5000 mg/kg
LD50 (females) > 5000 mg/kg
- Reason / purpose for cross-reference:
- reference to same study
Reference
- 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.
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 |
- Reason / purpose for cross-reference:
- reference to same study
Reference
- 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:
- supporting 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 non-occlusive conditions for 9 consecutive days.
- GLP compliance:
- not specified
- Species:
- guinea pig
- Strain:
- Hartley
- Remarks:
- CRL: (HA)BR Hartley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 349-425 g - Type of coverage:
- open
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 9 daily doses
- Observation period:
- 11 days
- Number of animals:
- five (5)
- Details on study design:
- no details given
- Remarks on result:
- probability of weak irritation
- Remarks:
- After the first dose on day 1 of treatment, slight erythema was observed in 4 of 5 test guinea pigs, and following the last dose on study day 9, moderate erythema was observed in 5 of 5 test guinea pigs. Edema, necrosis, and eschar formation were not observed in any test guinea pig at any time during the study. It was concluded that the test substance was determined to be slightly irritating.
- Irritant / corrosive response data:
- After the first dose on day 1 of treatment, slight erythema was observed in 4 of 5 test guinea pigs, and following the last dose on study day 9, moderate erythema was observed in 5 of 5 test guinea pigs. Edema, necrosis, and eschar formation were not observed in any test guinea pig at any time during the study. It was concluded that the test substance was determined to be slightly irritating.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article, m-diisopropylbenzene, was determined to be slightly irritating
- Executive summary:
In a skin irritation open repeat dose test a 0.5 mL aliquot of test substance (100 % test item) was applied topically to the shaved dorsal skin of guinea pigs each day for 9 consecutive days. After the first dose on day 1 of treatment, slight erythema was observed in 4 of 5 test guinea pigs, and following the last dose on study day 9, moderate erythema was observed in 5 of 5 test guinea pigs. Edema, necrosis, and eschar formation were not observed in any test guinea pig at any time during the study. It was concluded that the test substance was determined to be slightly irritating. As in this study the test item was applied on 9 consecutive days not just one time for 4 h as by the OECD Test Guideline 404, this is a clear worst-case result.
Repeated application resulted in a slight exacerbation of the initial irritant response.
Skin Absorption: Not evident (Based on Dermal LD50 and Skin irritation studies)
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- only 10 animals tested, not many details provided in the report
- Principles of method if other than guideline:
- only 10 animals tested, not many details provided in the report
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- in vivo study that was performed prior to current requirement for in vitro alternative testing
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 324 - 415g - Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 100% as received
- Day(s)/duration:
- 3 weekly doses
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 100% as received
- Day(s)/duration:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- no details given
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- 0% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Hours after challenge is not indicated
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 100% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Hours after challenge is not indicated . Doesn't show irritating sign
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not sensitizing in guinea pigs
- Executive summary:
A skin sensitisation test (Buehler method) was performed on guinea pigs. The test was done similar to OECD guideline 406. The sensitization potential of test item was assessed in guinea pigs using a Buehler test design. In the induction phase animals received 3 weekly applications of 100% of the test substance. Challenge was also performed with 100 % of the test substance. There were no signs of sensitization in any of the test animals. Consequently, the test substance was determined to be non-sensitizing in guinea pigs.
Preliminary tests had shown this material to be irritating to the abdomen, but not the backs of guinea pigs. During the course of the test, no irritation was observed during the induction phase using 100 % compound, so animals were challenged with the compound as received as well.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo study that was performed prior to current requirement for in vitro alternative testing
- Type of information:
- experimental study
- Adequacy of study:
- supporting 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
- GLP compliance:
- not specified
- Type of study:
- other: Kodak method
- Justification for non-LLNA method:
- in vivo study that was performed prior to current requirement for in vitro alternative testing
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 288 - 354g - Route:
- epicutaneous, occlusive
- Vehicle:
- other:
- Remarks:
- 0.05 mL of a 1 % solution in Freund's Complete Adjuvant
- Concentration / amount:
- 1% v/v
- Day(s)/duration:
- not specified
- Route:
- intradermal
- Vehicle:
- other: 70% acetone + 20% dioxane + 10% guinea pig fat
- Concentration / amount:
- 10% v/v
- Day(s)/duration:
- not specified
- No. of animals per dose:
- 10
- Details on study design:
- The Kodak test involved induction by application of 0.05 mL of a 1% solution of m-diisopropylbenzene in Freund's Complete Adjuvant (FCA). Prior to application, the skin was also depilated prior to application to enhance contact and absorption. Subsequently, animals were challenged by subcutaneous injection of a 10% v/v solution of the material into the foot pad of the test guinea pigs. The solvent that was used was prepared in the laboratory and consisted of 70% acetone, 20% dioxane, and 10% guinea pig fat.
- Challenge controls:
- Guinea pigs that were treated during the induction phase with FCA without test substance
- Positive control substance(s):
- no
- Reading:
- other: Day 1-3
- Group:
- negative control
- Dose level:
- 0% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- other: Day 1-3
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Slight to moderate erythema and slight edema was observed
- Reading:
- other: Day 1-3
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not sensitizing in guinea pigs
- Executive summary:
The skin sensitisation Kodak method test was performed on guinea pigs. The dermal application of 0.05 mL of a 1% solution of test item in Freund's Complete Adjuvant (FCA) topically to guinea pigs produced slight to moderate erythema and slight edema for 1 -3 days. Animals were subsequently challenged by subcutaneous injection of a 10% v/v solution of the material into the foot pad of the test guinea pigs. There was no evidence of sensitization in any of the test guinea pigs. Consequently, m-diisopropylbenzene was determined to be non-sensitizing in guinea pigs.
Slight to moderate erythema and slight edema was observed on days 1 -3 following induction with test item.
Low potential fur human sensitization
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- 1,3-diisopropylbenzene
- EC Number:
- 202-773-1
- EC Name:
- 1,3-diisopropylbenzene
- Cas Number:
- 99-62-7
- Molecular formula:
- C12H18
- IUPAC Name:
- 1,3-bis(propan-2-yl)benzene
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Applicant's summary and conclusion
- 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.
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