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EC number: 202-112-7 | CAS number: 91-97-4
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Skin Sensitization
TODI has a skin sensitisation potential (sensitiser) in the guinea pig maximization study.
Respiratory Sensitization
Although there is no respective study result for TODI available, TODI was classified as a substance that "may cause allergy or asthma symptoms or breathing difficulties if inhaled (H334)" as (1) TODI was found as sensitizer in a Magnusson & Kligman maximisation study in the guinea pig and (2) similar substances as e.g. MDI (CAS no. 9016-87-9) and 4,4'-Methylendicyclohexyldiisocyanat (CAS no. 5124-30-1; EC no. 225-863-2) are also labelled with H317 and H334 due to the isocyanic moiety as a common structural alert. Based on the available data described for similar isocyanates, a potential for respiratory sensitisation is likely for TODI too.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-11-03 to 1997-12-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This Guinea Pig Maximization Test (1998) met the previous REACH requirements of Annex VII, section 8.3 as the first version of LLNA (OECD 429) was issued in 2002. The GPMT is suitable and reliable to cover this endpoint. For this reason and for animal welfare reasons, no further in vivo study (LLNA test) needs to be performed.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 301 to 381 g
- Housing: single or in pairs
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 21
- Humidity (%): 46 to 66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 0.1% (w/v)
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: 1:1 Mixture of FCA/water
- Concentration / amount:
- 0.1 (w/v)
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 50% (w/w)
- Day(s)/duration:
- Day 7/48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 50% (w/w)
- Day(s)/duration:
- Day 21/24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 25% (w/w)
- Day(s)/duration:
- Day 21/ 24 hours
- Adequacy of challenge:
- other: One lower concentration than the highest non-irritant concentration
- No. of animals per dose:
- Total: 15 guinea pigs (10 test; five control)
- Details on study design:
- RANGE FINDING TESTS:
A. INTRADERMAL INDUCTION
- No. of exposures: four 0.1 mL injections of each concentration
- Concentrations: 5 %, 1 %, 0.5 %, 0.1 % (w/v) in arachis oil
- Evaluation after injection: 24, 48 and 72 hours and 7 days
B.TOPICAL INDUCTION
- Concentrations: 50 %, 25 %, 10 %, 5 % (w/w) in actone
- Exposure period: 48 hours
- Evaluation after dressing removal: 1 hour, 24 and 48 hours
MAIN STUDY
A.1 INDUCTION EXPOSURE (intradermal); on day 0
- No. of exposures: three pairs of injections (0.1 mL per injection)
- Site: left and right side of the mid-line (shoulder region)
- Frequency of applications: single injection
- Test group:
a) Freund's Complete Adjuvant plus destilled water in the ratio 1:1
b) 0.1 % w/v formulation of the test material in arachis oil BP;
c) 0.1 % w/v formulation of the test material in a 1:1 preparation of Freund's Complete Adjuvant plus destilled water
- Control group:
a) Freund's Complete Adjuvant plus destilled water in the ratio 1:1
b) arachis oil BP;
c) a 50% w/v formulation of arachis oil BP in Freund's Complete Adjuvant/distilled water 1:1
A.2 INDUCTION EXPOSURE (topical application); on day 7
- Test group: 50% test substance in acetone
- Control goup: acetone
- Site: shoulder region
- Duration: 48 hours
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: on Day 21
- Exposure period: 24 hours
- Test groups: 10
- Control group: 5
- Site: shorn right flank (50% test material formulation), left shorn flank (25% test material formulation)
- Concentrations: 50 % and 25 % in acetone
- Evaluation (hr after challenge): 24, 48 and 72 h
- Challenge controls:
- Yes
- Positive control substance(s):
- no
- Positive control results:
- None
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- See "any other information on results"
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- See "any other information on results"
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- See "any other information on results"
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- See "any other information on results"
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- See "any other information on results"
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- See "any other information on results"
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- TODI was assessed for skin sensitization in a maximization test in the albino guinea pig according to EU Method B.6/ OECD Guideline No. 406. It was concluded that under the conditions of the present assay, TODI has a skin sensitisation potential (sensitiser) in the maximisation study.
- Executive summary:
A study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method B6 of the Commission Directive 92/69/EEC.
Ten test and five control animals were used for the main study.
Based on the results of sighting test, the concentrations of test material for the induction and challenge phases were selected as follows:
Intradermal Induction: 0,1 % w/v in arachis oil BP
Topical Induction: 50 % w/w in acetone
Topical Challenge: 50% and 25 % w/w in acetone
The test material produced a 90 % (9/10) sensitisation rate. It was concluded that under the conditions of the present assay, TODI has a skin sensitisation potential (skin sensitiser) in the maximisation study.
Reference
Intradermal and Topical Sighting Test
Concentrations selected for the main study:
Intradermal induction: 0.1 % w/v in archis oil BP
Topical induction: 50 % w/w in acetone
Topical challenge: 50 % and 25 % w/w in acetone
Main Study
Skin reaction observed after intradermal induction:
Well-defined erythema was noted at the intradermal induction sites of the test group animals at the 24 and 48 -hour observations.
Very slight or well-defined erythema was noted at the intradermal induction sites of control group animals at the 24 and 48 -hour observations.
Skin reactions observed after topical induction:
Well-defined erythema and slight oedema was noted at the topical induction sites of all test group animals at the one hour observation. Incidents of very slight to well-defined erythema ans very slight to slight oedema were noted in test group animals at the 24-hour observation. Incidents of bleeding from the injection sites and bleeding wounds caused by the animal scratching the test site were also noted at the induction sites of test group animals at the 1-hour observation with small superficial scattered scabs, hardened dark brown/black coloured scab, crust formation or desquamation noted at the 24-hour observation. The degree of erythema and oedama could not be evaluated at the induction sites of four test group animals a the 24-hour observation.
Skin reactions observed after topical challenge:
25 % w/w in Arachis Oil BP
Positive skin responses ( very slight to well-defined erythema - grades 1 to 2), and incidents of very slight oedema or slight oedema were noted at the challenge sites of four test group animals at the 24-hour observation and one test group animal at the 48- and 72-hour observations. The degree of erythema could not be determined at the challenge sites of four test group animals at the 24 -hour observation because of other adverse reactions (hardened dark brown/black-coloured scab, scattered scabs and residual test material). These responses were attributed to contact sensitisation and therefore regarded as positive reactions. Very slight to slight oedema was also noted at two of these challenge sites at this time.
Residual test material and incidents of physical damage caused by attempted removal of adhered test material persisted at the challenge sites of nine test group animals at the 48-hour observation and nine test group animals at the 72-hour observation.
The degree of erythema could not be evaluated at the challenge sites of eight test group animals at the 48 and 72-hour observations. Similarly the degree of oedema could not be evaluated at the challenge sites of seven test group animals at the 48-hour observation and eight test group animals at the 72-hour observation. This was due to the severity of the other adverse reactions (hardened dark brown/black colured scab, physical damage to skin caused by attempted removal of adhered test material, loss of skin elasticity and flexibility, superficial cracking of the epidermis, desquamation, small superficial scattered scabs and crust formation).
Residual test material was noted at the challenge sites of all control group animals at the 24, 48 and 72-hour observations with physical damage to skin caused by attempted removal of adhered test material noted at none of these sites of control group animals.
50 % w/w in Arachis Oil BP
Posistive skin responses (very slight or well-defined erythema - grades 1 to 2) and incidents of very slight or sligth oedema were noted at the challenge sites of five test group animals at the 24-hour observation and two test group animals at the 48-hour observation. Slight oedema persisted at one of these challenge sites at the 72-hour observation. The degree of erythema could not be determined at the challenge sites of four test group animals at the 24 -hour observation, six test group animals at the 48 -hour observation and nine test goup animals at the 72-hour observation because of the severity of other adverse reactions noted. these included physical damage to skin caused by attempted removal of adhered test material, hardened dark brown/black coloured scab, small superficial scattered scabs, loss of skin elasticity and flexibility, crust formation and desquamation. The degree of oedema could also not be determiend at the challenge sites of three test group animals at the 24 -hour observation, six test group animals at the 48-hour observation and eight test gorup animals at the 72-hour observation. Incidents of residual test material were noted at the challenge sites of two control group animals at the 24, 48 and 72-hour observations, No skin reactions were noted at these times.
Body weight gains of guineaa pigs in the test group, between Day 0 and Day 25 were comparable to those observed in the control group animals over the same period.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method B6 of the Commission Directive 92/69/EEC.
Ten test and five control animals were used for the main study.
Based on the results of sighting test, the concentrations of test material for the induction and challenge phases were selected as follows:
Intradermal Induction: 0,1 % w/v in arachis oil BP
Topical Induction: 50 % w/w in acetone
Topical Challenge: 50% and 25 % w/w in acetone
The test material produced a 90 % (9/10) sensitisation rate. It was concluded that under the conditions of the present assay, TODI has a skin sensitisation potential (sensitiser) in the maximisation study.
Respiratory sensitisation
Link to relevant study records
- Endpoint:
- respiratory sensitisation, other
- Remarks:
- Expert Statement
- Type of information:
- other: Expert statement
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No study result but rational argumentation also considering structural analogue substances.
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- other: expert evaluation
- GLP compliance:
- no
- Species:
- other: not applicable
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- not applicable
- Route of induction exposure:
- other: not applicable
- Route of challenge exposure:
- other: not applicable
- Vehicle:
- other: not applicable
- Concentration:
- not applicable
- No. of animals per dose:
- not applicable
- Details on study design:
- not applicable
- Challenge controls:
- not applicable
- Results:
- Although there is no respective study result for TODI available, for precautionary reasons TODI was classified as a substance that "may cause allergy or asthma symptoms or breathing difficulties if inhaled" as (1) TODI was found as sensitizer in a Magnusson & Kligman maximisation study in the guinea pig and (2) similar substances as e.g. MDI (CAS no. 9016-87-9) and 4,4'-Methylendicyclohexyldiisocyanat (CAS no. 5124-30-1; EC no. 225-863-2) are also labelled with H317 and H334.
- Interpretation of results:
- sensitising
- Conclusions:
- Although there is no respective study result for TODI available, for precautionary reasons TODI was classified as a substance that "may cause allergy or asthma symptoms or breathing difficulties if inhaled" as (1) TODI was found as sensitizer in a Magnusson & Kligman maximisation study in the guinea pig and (2) similar substances as e.g. MDI (CAS no. 9016-87-9) and 4,4'-Methylendicyclohexyldiisocyanat (CAS no. 5124-30-1; EC no. 225-863-2) are also labelled with H317 and H334 due to the isocyanic moiety as a common structural alert. Based on the available data described for similar isocyanates, a potential for respiratory sensitisation is likely for TODI too. Therefore the TODI is expected to be a respiratory sensitiser.
- Executive summary:
Although there is no respective study result for TODI available, for precautionary reasons TODI was classified as a substance that "may cause allergy or asthma symptoms or breathing difficulties if inhaled" as (1) TODI was found as sensitizer in a Magnusson & Kligman maximisation study in the guinea pig and (2) similar substances as e.g. MDI (CAS no. 9016-87-9) and 4,4'-Methylendicyclohexyldiisocyanat (CAS no. 5124-30-1; EC no. 225-863-2) are also labelled with H317 and H334 due to the isocyanic moiety as a common structural alert. Based on the available data described for similar isocyanates, a potential for respiratory sensitisation is likely for TODI too. Therefore the TODI is expected to be a respiratory sensitiser.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Although there is no respective study result for TODI available, TODI was classified as a substance that "may cause allergy or asthma symptoms or breathing difficulties if inhaled" as (1) TODI was found as sensitizer in a Magnusson & Kligman maximisation study in the guinea pig and (2) similar substances as e.g. MDI (CAS no. 9016-87-9) and 4,4'-Methylendicyclohexyldiisocyanat (CAS no. 5124-30-1; EC no. 225-863-2) are also labelled with H317 and H334 due to the isocyanic moiety as a common structural alert. Based on the available data described for similar isocyanates, a potential for respiratory sensitisation is likely for TODI too. Therefore the TODI is expected to be a respiratory sensitiser.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is considered to be classified for skin sensitization Cat. 1A (H317) and respiratory sensitization Cat. 1 (H334) under Regulation (EC) No 1272/2008, as amended for the seventeenth time in Regulation (EU) 2021/849.
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.
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