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EC number: 619-370-5 | CAS number: 98725-11-2
- 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:
- study according to OECD guideline 404, GLP, New Zealand rabbits were exposed to 0.5 g MDAB for 4 h, not irritating, read-across
- study according to OECD guideline 404, GLP, New Zealand rabbits were exposed to 0.5 g ABH for 4 h, not irritating , read-across
Eye irritation:
- study according to OECD guideline 405, GLP, 0.1 g of MDAB were instilled into the conjunctival sac of the left eye of three New Zealand rabbits, theanimals were observed for 7 days, reading intervals: 1, 24, 48 and 72 h after application, not irritating, read-across
- study according to OECD guideline 405, GLP, 0.1 g of ABH were instilled into the conjunctival sac of the left eye of three New Zealand rabbits, theanimals were observed for 21 days, reading intervals: 1, 24, 48 and 72 h after application, not irritating, read-across
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:
- weight of evidence
- 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:
- February, 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, female 15 weeks
- Weight at study initiation: males 2.4 - 2.5 kg, female 2.6 kg
- Fasting period before study: overnight
- Housing: female individually, males 2 animals/cage; stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen)
- Diet: ad libitum, pelleted standard Kliba 341, Batch 48/89 rabbit maintenance diet ("Kliba", Klingenmuehle AG, CH-4303 Kaiseraugst)
- Water: ad libitum, community tap water from Itingen
- Acclimation period: 4 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:
- unchanged (no vehicle)
- Remarks:
- The test article was applied moistened with bi-distilled water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g/animal. The test article was applied moistened with bi-distilled water.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 h with the reading points: 1, 24, 48 and 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). On test day 1, 0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze.
- Type of wrap if used: Covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The 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): Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water.
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 h
SCORING SYSTEM: Draize scoring system
- Method of calculation: according to 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
- 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
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The test item showed a primary irritation score of 0.00, when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident an the skin.
- Other effects:
- Coloration: In the area of application no staining of the treated skin by pigment or coloring of the test article was observed.
Body weights: The body weight gain of all rabbits was similar.
Clinical symptoms / Mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
Necropsy: No necropsy was performed. All animals were killed and discarded. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this experiment, The test substance was found to cause a primary irritation score of 0.00, when applied to intact rabbit skin. There was no sign of irritation, thus, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with respect to skin irritation.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1989-10-27 to 1989-12-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- 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:
- not reported
- 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: females: 15 weeks; male: 14 weeks
- Weight at study initiation: females: 3.0 kg; male: 2.5 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-Emmendingen)
- Diet (e.g. ad libitum): ad libitum, pelleted standard Kliba 341, Batch 48/89 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4304 Kaiseraugst)
- Water (e.g. ad libitum): ad libitum, Community tap water from Itingen
- Acclimation period: four days under test condictions 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:
- unchanged (no vehicle)
- Remarks:
- moistened with bi-distilled water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4h
- Observation period:
- 72 h, reading intervals: 1, 24, 48 and 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: patch of surgical gauze covered with a semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): four hours after the application the skin was flushed with lukewarm tap water
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
1, 24, 48 and 72 h after the removal of the dressing
SCORING SYSTEM:
- Method of calculation: The results were scored according to OECD guideline 404 (Draize et al.) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the present study conducted according to OECD guideline 404, GLP-compliant, three New Zealand White rabbits were dermally exposed under semi-occlusive conditions to 0.5 g test substance for 4h. After the 4h treatment the remaining substance was removed and the appearance of erythema and edema was scored. Mean erythema scoring for 24, 48 and 72h was 0.33/0.33/0, mean edema scoring for 24, 48 and 72h was 0/0/0. Therefore, the substance does not meet the GHS criteria for classification and is not classified and labeled according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
Referenceopen allclose all
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 |
Erythema |
Edema |
Max. score: 4 |
Max. score: 2 |
|
24 h |
2/1/1 |
0/0/0 |
48 h |
1/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
1/0.33/0.33 |
0/0/0 |
Reversibility*) |
c. |
c. |
Average time (h) for reversion |
48h |
No effect occurred |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
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 1989-12-19
- 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)
- 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: males 14 weeks, female 15 weeks
- Weight at study initiation: males 2.5-2.6 kg, female 2.4 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing WE. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen)
- Diet: ad libitum, pelleted Kliba 341, Batch 48/89 and 49/89 rabbit maintenance diet ("Kliba", Kingenmuehle AG, CH-4303 Kaiseraugst)
- Water: ad libitum, community tap water from Itingen
- Acclimation period: 4 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: untreated eye of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g of the test substance was instilled into the conjunctival sac of the left eye
- Concentration: undiluted - Duration of treatment / exposure:
- 7 days, single exposure, no washing
- Observation period (in vivo):
- 7 days, Reading points: 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test article (0.1 g per animal) was 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. The right eye remained untreated and served as the reference control.
REMOVAL OF TEST SUBSTANCE
- Washing : No
SCORING SYSTEM: According to OECD guideline 405 (Draize et al.)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Corrosion: Corneal opacity was observed in one animal (no.71, female) from 1 to 72 hours after treatment. No opacity was observed in any other animal.
- Other effects:
- Clinical symptoms / Mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
Coloration: No staining of the cornea and conjunctivae of the treated eyes by pigment or coloring of the test article was observed.
Body weights: The body weight gain of all rabbits was similar.
Necropsy: No necropsy was performed. All animals were killed and discarded. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the present study conducted according to OECD guideline 405 (adopted February 24, 1987) 0.5 g Compimide MDAB were instilled into the conjuctival sac of three New Zealand White rabbits (two male and one female animal). The treated eyes were not rinsed and the effects of the test item were recorded at 1h, 24h, 48h and 72h after application. After another 21 days observation period the animals were sacrificed and discarded. In all three animals a slight conjunctival redness was detected at the 72h reading (score 1) but the redness was fully reversible within 7 days, thus, the test item does not need to be classified according to Regulation (EC) No 1272/2008 (CLP) and the globally harmonized system of classification and labelling of chemicals (GHS).
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1989-11-02 to 1989-12-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- 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:
- not reported
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- SPF-quality
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: females: 15 weeks; male: 14 weeks
- Weight at study initiation: females: 2.5-2.7 kg; male: 2.6 kg
- Housing:Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-Emmendingen)
- Diet (e.g. ad libitum): ad libitum, pelleted standard Kliba 341, Batch 48/89 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4304 Kaiseraugst)
- Water (e.g. ad libitum): ad libitum, Community tap water from Itingen
- Acclimation period: four days under test condictions 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:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the substance were instilled into the conjunctival sac of the left eye. - Duration of treatment / exposure:
- 21 days, single exposure, no washing
- Observation period (in vivo):
- The animals were observed for 21 days with the reading time points: 1, 24, 48 and 72 hours after exposure
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: according to OECD guideline 405
TOOL USED TO ASSESS SCORE: Eye examinations were made with a slit-lamp 30 SL/M (C. ZeissAG, Zuerich, Switzerland)
100 mg of the test article (undiluted) was 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. The eyes were not rinsed. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the present study conjducted according to OECD guideline 405 (adopted February 24, 1987), 0.1 g m-aminobenzohydrazide (ABH) were instilled into the conjunctival sac of the left eye of three New Zealand rabbits. The eyes were not rinsed and the effects of the substance on the rabbit eye were assessed at 1, 24 48 and 72h after application of the substance. The opacity score was < 1 (0/0/0), the iris score was < 1 (0/0/0), the conjuntivae score was < 2 (0.67/0.67/0.67) and the chemosis score was < 2 (0/0/0.33). Therefore, ABH is considered to be not irritating to the eye and is not classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemcials (GHS).
Referenceopen allclose all
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 |
0/0/1 |
0/0/1 |
2/2/2 |
1/1/2 |
48 h |
0/0/1 |
0/0/0 |
2/2/2 |
0/0/1 |
72 h |
0/0/1 |
0/0/0 |
1/1/1 |
0/0/0 |
Average 24h, 48h, 72h |
0/0/1 |
0/0/0.33 |
1.67/1.67/1.67 |
0.33/0.33/1 |
Reversibility*) |
c. |
c. |
c. |
c. |
Average time for reversion |
72h |
72h |
7days |
72h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
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 |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/1 |
48 h |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0/0/0 |
0/0/0 |
0.67/0.67/0.67 |
0/0/0.33 |
Reversibility*) |
c. |
c. |
c. |
c. |
Average time (h) for reversion |
48 |
48 |
48 |
48 |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are no experimental data on the target substance Compimide 183 available. However, irritation/corrosion studies are available for the source substance MDAB and ABH. A detailed justification for read-across is attached to IUCLID section 13.
Irritation/Corrosion
Skin irritation/corrosion
No data about skin irritation/corrosion for the target substance Compimide 183 are available. However, there are reliable data for the structurally similar source substances MDAB and ABH.
In study conducted according to OECD guideline 404, GLP, 3 New Zealand rabbits were dermally exposed to 0.5 g MDAB for 4 h under semi-occlusive conditions. The animals were observed for 72 h after the 4 h exposure time. The reading-intervals were: 1 h, 24 h, 48 h and 72 h. There were no signs of irritation at any timepoint of the observation period, thus MDAB was not classified as skin irritant according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
In study conducted according to OECD guideline 404, GLP, 3 New Zealand rabbits were dermally exposed to 0.5 g ABH for 4 h under semi-occlusive conditions. The animals were observed for 72 h after the 4 h exposure time. The reading-intervals were: 1 h, 24 h, 48 h and 72 h. Slight irritation was observed 24 h after application which was fully reversible within the 72 h of the observation period, thus ABH was not classified as skin irritant according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
Eye irritation/corrosion
In study conducted according to OECD guideline 405, GLP, 0.1 g of MDAB were instilled into the conjunctival sac of the left eye of 3 New Zealand rabbits. The animals were observed for 7 days after exposure with the following reading-intervals: 1 h, 24 h, 48 h and 72 h. Slight corneal opacity, irritation of the iris and chemosis and a moderate conjunctival irritation was detected in one animal at least one reading timepoint of the observation period but these effects were fully reversible within 7 days, thus MDAB was not classified as skin irritant according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
In study conducted according to OECD guideline 405, GLP, 0.1 g of ABH were instilled into the conjunctival sac of the left eye of 3 New Zealand rabbits. The animals were observed for 7 days after exposure with the following reading-intervals: 1 h, 24 h, 48 h and 72 h. Slight conjunctival irritation was detected in all animals at least two reading timepoints and one animal showed chemosis at the 24 h reading timepoint of the observation period. These effects were fully reversible within 48 h, thus ABH was not classified as skin irritant according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
Justification for classification or non-classification
Based on the results of the reported skin and eye irritation studies neither MDAB no ABH are irritating to the skin or the eyes, thus, also Compimide 183 (the reaction product of both compounds) is considered to be not irritating to the skin and the eyes and does not need to be classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemcials (GHS).
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