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EC number: 202-442-1 | CAS number: 95-70-5
- 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
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Endpoint summary
Administrative data
Description of key information
On each of the two endpoints skin and eye irritation, two in-vivo studies have been carried out with 2.5% and 50% aqueous solutions of target chemical toluene-2,5-diamine. No skin irritation effects observed, however the classification as eye irritant would apply for 50% aqueous solutions of target chemical toluene-2,5-diamine
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:
- 1994-05-05 to 1994-12-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline-conform study under GLP. Evaluation of erythema was not possible due to staining effects caused by the test item, thus unambiguously clear conclusions cannot be drawn from the available data. The study therefore is considered as reliable with restrictions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France- Age at study initiation: no data- Weight at study initiation: 2.4 +/-0.1 kg- Housing: individually in polystyrene cages- Diet (e.g. ad libitum): pelleted diet ad libitum- Water (e.g. ad libitum): drinking water filtered by a F.G Millopore membrane (0.22 microns) provided ad libitum - Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 +/- 3 °C- Humidity (%): 30 - 70 %- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): 12 h / 12 hIN-LIFE DATES: From: 1994-05-20 To: 1994-05-30
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 mL- Concentration (if solution): 50.6 %VEHICLEnot applicable
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 6 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE- Area of exposure: right flank- % coverage: test substance was applied to a 6 cm2 gauze patch, which then was applied to the right flank- Type of wrap if used: test substance and gauze patch were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage REMOVAL OF TEST SUBSTANCE- Washing (if done): substance was removed with a gauze patch moinstened with paraffin oil- Time after start of exposure: 4 hSCORING SYSTEM:Erythem and eschar formation:no erythema: 0very slight erythema: 1well-defined erythema: 2moderate to severe erythema: 3very erythema (beet redness) to slight eschar formation (injuries in depth): 4Oedema formation:no oedema: 0very slight oedema: 1slight oedema: 2moderate oedema (raised approx. 1 mm): 3severe oedema (raised more than 1 mm and extending beyong the area of exposure): 4
- Irritation parameter:
- erythema score
- Remarks:
- black colouration of the skin which could obscure an eventual erythema at grades 1 to 3
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- > 1 - < 3
- Reversibility:
- not reversible
- Remarks on result:
- not determinable
- Remarks:
- black colouration of the skin which could obscure an eventual erythema at grades 1 to 3
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not concerned, no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not concerned, no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not concerned, no effects
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- black colouration of the skin which could obscure an eventual erythema at grades 1 to 3
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- > 1 - < 3
- Max. score:
- 0
- Reversibility:
- not reversible
- Remarks:
- black colouration of the skin which could obscure an eventual erythema at grades 1 to 3
- Remarks on result:
- not determinable
- Irritation parameter:
- erythema score
- Remarks:
- black colouration of the skin which could obscure an eventual erythema at grades 1 to 3
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- > 1 - < 3
- Reversibility:
- not reversible
- Remarks on result:
- not determinable
- Remarks:
- black colouration of the skin which could obscure an eventual erythema at grades 1 to 3
- Irritant / corrosive response data:
- None reported.
- Other effects:
- In all 3 animals black colouration of the treated site by residual test substance had prevented the evaluation of a well-defined and a moderate to severe erythema over the 6 days observation period.
- Interpretation of results:
- other: Development of erythema basically possible, however this could not be evaluated due to staining effects caused by the test item.
- Remarks:
- Criteria used for interpretation of results: not specified
- Conclusions:
- No oedema, ulceration or necrosis was being observed during the study period. According to the study report, it is being concluded that under the given experimental conditions the test item IMEXINE OD (still) could provoke moderate or severe irritant effects when administered by cutaneous route to rabbits, as erythema could not be evaluated due to skin staining effects caused by the test item.
- Executive summary:
The purpose of the study was to evaluate the dermal irritation properties of test item IMEXINE DO, which contains 50.6% of target chemical toluene-2,5 -diamine in aqueous solution. the study followed the protocol as given by OECD Guideline 404. No oedema, ulceration or necrosis was being observed during the study period. In all 3 animals black colouration of the treated site by residual test substance had prevented the evaluation of a well-defined and a moderate to severe erythema over the 6 days observation period. Event though no actual dermal irritation effects were being noted in the study report, it is being concluded by the study director that under the given experimental conditions the test item IMEXINE OD could provoke moderate or severe irritant effects when administered by counateous route to rabbits, in this way taking into accout a worst case assumption.
Reference
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:
- 1994-05-10 to 1994-08-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study without deviations, under GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France- Age at study initiation: no data- Weight at study initiation: 2.75 kg- Housing: individually in polystyrene cages- Diet (e.g. ad libitum): pelleted diet ad libitum- Water (e.g. ad libitum): drinking water filtered by a F.G Millopore membrane (0.22 microns) provided ad libitum - Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 +/- 3 °C- Humidity (%): 30 - 70 %- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): 12 h / 12 hIN-LIFE DATES: From: 1994-06-25 To: 1994-06-08
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 mL- Concentration (if solution): 50.6 %VEHICLEnot applicable
- Duration of treatment / exposure:
- 8 days (over the whole observation period, no rinsing of treated eye)
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCEnot doneSCORING SYSTEM: According to the study report, the classification was based on criteria laid down in Directive 91/325/ECC Commission Directive of 1st March 1991 adapting to the technical progress for the twelth time Council Directive 67/548/ECC. - Chemosis: scoring range 0 - 4- Redness: scoring range 0 - 3- Discharge: scoring range 0 - 3- Iritis: scoring range 0 - 2- Cornea opacity: scoring range 0 - 4- Cornea area of opacity: scoring range 0 - 4- 0: no effects observed; highest figures, respectively: most severe effects observed; inbetween grading by whole number steps TOOL USED TO ASSESS SCORE: fluorescein
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- intensity of opacity
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- area of opacity
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- not measured/tested
- Irritant / corrosive response data:
- in the study report, the study director names 24 h reading day 2, 48 h reading day 3, and 72 h day 4, etc. However it is considered appropriate to name the 24 h reading day 1, the 48 h reading day 2, and the 72 h reading day 3, etc., which is reflecting to the data presented in above table.
- Other effects:
- none
- Interpretation of results:
- irritating
- Remarks:
- Migrated information50.6% toluene-2.5-diamineCriteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the experimental conditions, test item IMEXINE OD (i.e. 50.6 % of target chemical toluene-2,5-diamine in aqeous solution) was considered as irritating to eye (category 2, as effects were fully reversible) when administered by ocular route to one rabbit.
- Executive summary:
The purpose of this study was to evaluate the eye irritating potential of test item IMEXINE OD (i.e. 50.6 % of target chemical toluene-2,5-diamine in aqeous solution). The study followed the protocol as given by OECD Guideline 405. Only one rabbit was being treated with 0.1 mL of IMEXIDINE OD, without rinsing of the eye.
The most significant irritation scores as overall average of the 24 h, 48 h, and 72 h readings were as follows:
- Iritis: 1.0
- Corneal opacity (intensity): 1.3
- Conjunctival redness: 3.0
- Chemosis: 3.7
As all obseved irritating effects were fully reversible within 7 days, test item IMEXINE OD (i.e. 50.6 % of target chemical
toluene-2,5-diamine in aqeous solution) shall be considered as irritating to eyes category 2, H319, according to the CLP classification system, and as Xi; R36, irritating to eyes, according to the former DSD classification system.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
No oedema, ulceration or necrosis was being observed during the study period. According to the study report, it is being concluded that under the given experimental conditions the test item IMEXINE OD (still) could provoke moderate or severe irritant effects when administered by cutaneous route to rabbits, as erythema could not be evaluated due to skin staining effects caused by the test item.
Eye irritation:
Study on 2.5% toluene-2,5 -diamine:
No significant eye irritating effects were being observed.
Study on 50.6% toluene-2,5 -diamine:
Under the experimental conditions, test item 50.6 % of target chemical toluene-2,5-diamine in aqeous solution was considered as irritating to eye (category 2, as effects were fully reversible) when administered by ocular route to one rabbit.
Conclusion:
As temporary conclusion, based on the available data target chemical toluene-2,5 -diamine shall be considered as irritant to eyes. Without information of 100% test material, the worst case is supposed with highly irritant effect.
Justification for selection of skin irritation / corrosion
endpoint:
weight on evidence based on two avaialble studies of reliability 2
Justification for selection of eye irritation endpoint:
Under the experimental conditions, test item IMEXINE OD (i.e. 50.6 %
of target chemical toluene-2,5-diamine in aqeous solution) was
considered as irritating to eye (category 2, as effects were fully
reversible) when administered by ocular route to one rabbit.
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: highly irritating
Justification for classification or non-classification
Skin irritation:
Based on data available at this point of time, no classification applicable, as no classification-relevant skin irritating effects were being observed in the studies
Eye irritation:
Based on data available from the study with 50% toluene-2,5 -diamine, following temporary classification for toluene-2,5 -diamine shall apply.
GHS/CLP: causes serious eye damage Category 1, H318
DSD: Xi; R41, Risk of seriuos damage to eyes
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