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EC number: 229-175-3 | CAS number: 6422-83-9
- 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
- Skin irritation/corrosion: not irritating; OECD TG 404; RL 1; GLP
- Eye irritation/corrosion: serious eye damage (Category 1); OECD TG 405; RL1; GLP
- Respiratory irritation: no study available
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:
- 1989-10-27 to 1989-12-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- March, 1984
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: males: 14 weeks, females: 15 weeks
- Weight at study initiation: males: 2.9 kg, females: 2.4-2.6 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen).
- Diet (e.g. ad libitum): ad libitum, Pelleted standard Kliba 341, Batch 48/89 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Four days under test conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- bi-distilled
- Amount / concentration applied:
- Amount(s) applied: 0.5 g / animal
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h, reading intervals: 1, 24, 48 and 72 h
- Number of animals:
- 1 male and 2 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² intact shaved skin
- % coverage: 3.0 x 3.0 cm
- Type of wrap if used: A patch of surgical gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure the skin was flushed with lukewarm tap water.
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48, 72 h
SCORING SYSTEM: according to OECD guideline
- Method of calculation: To classify the irritating property of the test article, the mean values of erythema/eschar as well as of edema formation were calculated for each individual, using the scores between 24 and 72 hours (EEC Council Directive 83/467/EEC, July 1983, Brussels/Belgium). - Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study conducted according to OECD guideline 404, the test item caused no skin irritating/corrosive reactions. The individual mean values for both erythema and edema from gradings at 24, 48 and 72 h were 0 in all three animals. Therefore, the test item does not fulfil the criteria for classification according to Regulation (EC) 1272/2008 (CLP) and the Globally Harmonized system of Classification and Lablelling of Chemical (GHS), and is thus considered to be not skin irritating.
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:
- 1989-11-02 to 1990-01-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- March, 1984
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: male 14 weeks, females 15 weeks
- Weight at study initiation: male 2.8 kg, females 2.3 - 2.5 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen).
- Diet (e.g. ad libitum): ad libitum, Pelleted standard Kliba 341, Batch 48/89 and 49/89 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst)
- Water (e.g. ad libitum): ad libitum, Community tap water from Itingen
- Acclimation period: Four days under laboratory conditions after veterinary examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g per animal were placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. - Duration of treatment / exposure:
- Single instillation without rinsing
- Observation period (in vivo):
- 21 days; reading intervals: 1, 24, 48 and 72 h, 14 and 21 days post-instillation
- Number of animals or in vitro replicates:
- 1 male and 2 females
- Details on study design:
- SCORING SYSTEM: The irritation was assessed according to the numerical scoring system provided by OECD guideline 405
TOOL USED TO ASSESS SCORE: Eye examinations were made with a slit-lamp 30 SLIM (C. Zeiss AG, Zuerich/Switzerland) and a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel/Switzerland). - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: score 3 at day 21
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: score 1 at day 21
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- conjunctival redness
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: score 1 at day 21
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritant / corrosive response data:
- Corneal opacity was observed in all animals at any of the measuring intervals. Partly corrosion of the conjunctivae was observed in two animals from 24 hours to 7 days, and in one animal from 48 hours to 7 days after treatment. Yellow staining of the eyelashes of the treated eyes by pigment or coloring of the test article was observed in all animals 1 hour after treatment.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the conditions of the study conducted according to OECD guideline 405, the test material was found to cause corrosive/irriversible effects to the rabbit eye. The mean scores for corneal opacity, iritis, conjunctival redness and chemosis from gradings at 24, 48 and 72 h were 2.67, 1, 2, 3in all three animals. Corneal opacity and conjunctival redness observed in all animals and iritis in one animal were not reversible up to the end of the 21-day observation period. Therefore, the test material fulfils the criteria for classification as eye corrosive Category 1 according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to cause serious eye damage.
Reference
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
24 h |
2/2/2 |
1/1/1 |
2/2/2 |
3/3/3 |
48 h |
3/3/3 |
1/1/1 |
2/2/2 |
3/3/3 |
72 h |
3/3/3 |
1/1/1 |
2/2/2 |
3/3/3 |
Average 24h, 48h, 72h |
2.67/2.67/2.67 |
1/1/1 |
2/2/2 |
3/3/3 |
Reversibility*) |
n. |
n.c. |
n.c. |
c. |
Average time (unit) for reversion |
21 (d) |
21 (d) |
21 (d) |
21 (d) |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Approximately 24 h before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm).
After removal of the test patch the skin reaction was assessed at 1, 24, 48 and 72 h. The corrosive properties of the test article and the staining of the treated skin area related to the test article were described and recorded. The scores for each type of lesion was calculated according to EEC Council Directive, 83/467/EEC, July 1983 Brussels, Belgium.
Viability of the animals was recorded daily, body weights were assessed at day 1 of the test and at termination of observation. The observation was terminated 72 h after application of the test article. All rabbits were killed and discarded.
Under the conditions of this experiment, 2,4 -Bismaleimidotoluene was found to cause a primary irritation score of 0.00 and local signs (mean 1 h to 72 h) of grade 0.00 erythema and grade 0.00 edema. No staining of the treated skin by pigment or colouring of the test article was observed. No corrosive effect had occurred on the skin at any measuring interval. Thus, 2,4 -Bismaleimidotoluene is considered to be not irritating to the skin.
Eye irritation
In a primary eye irritation study according to OECD guideline 405 (February 24, 1987) 0.1 g of 2,4 -Bismaleimidotoluene was instilled into the conjunctival sac of the left eye of 3 young adult New Zealand White rabbits. The untreated right eyes served as controls. The eyes were not rinsed after application. Animals were then observed for 21 days.
The cornea opacity, the iris, the conjunctivae and chemosis were scored 2.67, 1.00, 2.00 and 3.00, respectively, in all animals. All effects except the ones on the iris were not reversible in all animals (in one animal the iris was scored 0 at the end of the 21 days period) within 21 days.
Beside the irritation scores other effects like coloration, corrosion, toxic symptoms and body weights were observed. No acute clinical symptoms and no mortality occurred during the observation period. But yellow staining of the eyelashes of the treated eyes by pigment or colouring of the test article was observed in all animals 1 h after treatment. Corneal opacity was observed in all animals at any of the measuring intervals. Partly corrosion of the conjunctivae was observed in two animals from 24 h to 7 days, and in one animal from 48 h to 7 days after treatment. Thus, the substance is considered to cause "irreversible effects on the eye".
Respiratory irritation
No data on the respiratory irritation of 2,4 -Bismaleimidotoluene are available.
There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.
Justification for classification or non-classification
Skin irritation
Based on reliable, adequate and relevant data, 2,4 -Bismaleimidotoluene does not need to be classified for skin irritation according to Regulation (EC) 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
Eye irritation
Based on reliable, adequate and relevant data, 2,4 -Bismaleimidotoluen has to be classified as Category 1, irreversible effects on the eye according to CLP, EU GHS (Regulation (EC) No 1272/2008 and the Globally Harmonized System for Classification and Labelling of Chemicals) and is assigned the hazard statement H318 and the signal word “Danger”.
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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