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EC number: 618-561-0 | CAS number: 9046-10-0
- 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: Skin irritation studies of sufficient quality and conducted in a method comparable to OECD guideline 404 showed that the test substance was corrosive to rabbit skin.
Eye irritation: An eye irritation study of sufficient quality and conducted in methods comparable to OECD guideline 405 showed that the test substance was corrosive to rabbit eyes. pH value of 11.7 indicated that the test substance was corrosive.
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:
- 1982-08-30 to 1982-09-02
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Limited details were provided on the test substance (e.g., purity was lacking) and environmental conditions of animals. Details on measurement of the area of test application site was missing, but it can be assumed that it was smaller than the recommended 6cm^2 based on the patch that covered it was only 1 in^2. Observations were only made at 4 and 44 hours after test substance administration.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Limited details were provided on the test substance (e.g., purity was lacking) and environmental conditions of animals. Details on area of test application site was missing. Observations were only made at 4 and 44 hours.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name as cited in study report: poly[oxy(methyl-1,2-ethanediyl)], alpha-(2-aminomethylethyl)-omega-(2-aminomethylethoxy)
- Substance type: Active
- Color: clear
- Storage: no change in physical state of test substance during administration
-Lot: 5601-9-1, order#J-154 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Douglassville, Pennsylvania
- Weight at study initiation: 2-3 kg
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1982-08-30To: 1982-09-01 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml was applied once directly on the intact skin site (one non-abraded skin site per animal). - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Animals were observed at 4 and 44 hours after treatment.
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: All application sites were clipped free of fur and non-abraded. No further information was provided on the area of exposure.
- Type of wrap if used: Following the application of the test substance, one-inch square gauze patches were applied to the test site. The trunk of the animal was then wrapped with a rubber dam and an Ace bandage to retard evaporation.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the four hour exposure period, the wrappings were removed and the skin was wiped to remove any remaining test substance.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Corrosion was considered to have resulted if the test substance in contact with the rabbit skin had caused destruction or irreversible alteration of the tissue on at least two out of each six rabbits tested. Tissue destruction was considered to have occurred if at any of the readings there was ulceration or necrosis. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4h
- Remarks on result:
- other: visible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 44h
- Remarks on result:
- other: visible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4h
- Remarks on result:
- other: visible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 44h
- Remarks on result:
- other: visible
- Irritation parameter:
- other: necrosis
- Basis:
- mean
- Time point:
- other: 4h
- Remarks on result:
- other: visible in 2 out of 6 rabbits
- Irritation parameter:
- other: necrosis
- Basis:
- mean
- Time point:
- other: 44h
- Remarks on result:
- other: visible in 5 out of 6 rabbits
- Irritant / corrosive response data:
- Erythema and edema were visible at 4 and 44 hours after treatment. Signs of necrosis were visible in two of six rabbits at the 4 hour reading and in five of six rabbits at the 44 hour observation period. Based upon the results, the test substance was considered to be corrosive.
- Interpretation of results:
- corrosive
- Conclusions:
- The test substance was evaluated for primary dermal corrosivity in rabbits. Based on the results of the study, the test substance was determined to be corrosive and considered to be classified as category 1C according to CLP Regulation.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1978-12-12 to 1979-01-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Limited details were provided on the test substance (e.g., purity was lacking), animals and environmental conditions. Details on measurement of the area of test application site was missing, but it can be assumed that it was smaller than the recommended 6cm^2 based on the patch that covered it was only 2.5 cm^2. Observations were only made at 24 and 72 hours after treatment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Limited details were provided on the test substance (e.g., purity was lacking), animals and environmental conditions. Details on size of testing site were lacking. Observations were only made at 24 and 72 hours after treatment.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name as cited in study report: Poly[oxy(methyl-1,2-ethanediyl)], alpha-(2-aminomethylethyl)-omega-(2-aminomethylethoxy)
- substance type: Active
- Date of receipt: 1978-11-03 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: at least 8 weeks
- Housing: The animals were housed in elevated wire cages in a temperature controlled room reserved exclusively for rabbits on acute tests.
- Diet (e.g. ad libitum): ad libitum (fresh Purina Rabbit Chow)
- Water (e.g. ad libitum): ad libitum (tap water)
- Other: The animals selected were in good health when received from the local supplier and remained in good health during the equilibration period in the laboratory. The cages and room were kept clean in accordance with the standards of AAALAC of which the laboratory was an approved member. - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped (abraded and non-abraded areas were included)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 24 hours
- Observation period:
- The animals were scored at 24 hours and 72 hours after treatment.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: Prior to treatment the fur was clipped from the backs and sides of the test animals with an Oster Model 2 clipper with an ANG-RA clipper head designed specifically for clipping rabbits. The left-side of the spinal column of each rabbit was abraded with a 21 gauge bent tip needle. The abrasions scratched the stratum corneum but did not reach the derma or produce bleeding. Three abrasions, approximately 2-3 cm apart, extending the length of the exposure site were made on each back. The right side of each back was not abraded. The test substance was applied to one abraded and one intact site per rabbit.
- Type of wrap if used: the test substance was covered with 2 ply gauze, 2.5 cm square. The patches were secured with adhesive tape and the entire trunk of the rabbit was wrapped with impervious material, 2 ml thick plastic.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
SCORING SYSTEM: the scoring system of Draize was used. The primary dermal index was calculated as cited in 16 CFR 1500.41. By definition, a primary irritatant was a substance which was not corrosive and had an empirical score of 5 or more (16 CRF 1500.3). See scoring scale below. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: combination of 48 and 72 hour observations
- Score:
- ca. 6.54
- Max. score:
- 8
- Reversibility:
- no data
- Irritant / corrosive response data:
- The skin reactions observed were, in some instances, greater than the highest value on the Draize scale. These were noted as 4+. The test substance was therefore considered to be corrosive.
- Interpretation of results:
- corrosive
- Conclusions:
- The test substance was evaluated for dermal irritation in New Zealand White Rabbits. The skin reactions observed were in some instances greater than the highest value on the Draize scale. Therefore, the test substance was considered to be corrosive.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1984-12-05 to 1984-12-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Study conducted with methods similar to OECD Guideline 404. However, details on the test substance (e.g, purity) were lacking. Details on application site were limited (location and size were missing). Results were limited.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Details on the test substance (e.g., purity) were lacking. Details on application site were limited (location and size were missing). Results were limited.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name as cited in study report: Poly[oxy(methyl-1,2-ethanediyl)], alpha-(2-aminomethylethyl)-omega-(2-aminomethylethoxy)
- Substance type: Active
- Color: clear
- Stability: no change in physical state of test substance during administration - Species:
- rabbit
- Strain:
- other: Albino New zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, Pennsylvania
- Weight at study initiation: 2-3 kg
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): ad libitum (Wayne Rabbit Ration)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1984-12-05 To: Termination date was listed as 1984-12-05. No data was provided if the animals were sacrificed. - Type of coverage:
- not specified
- Preparation of test site:
- other: clipped free of hair
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml was applied directly on the intact skin sites. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Animals were observed at 3 and 60 minutes and 4 hours after treatment.
- Number of animals:
- 2 males and 1 female
- Details on study design:
- TEST SITE
- Area of exposure: The test substance was applied directly on the intact skin sites (one site per animal). However, no further information was provided on the sties.
SCORING SYSTEM: The test substance was classified by the length of time of contact necessary to produce visible necrosis of the skin tissue as follows:
1. Group 1 (very dangerous)-caused visible necrosis of the skin tissue in 3 minutes or less
2. Group 2 (medium danger)- caused visible necrosis of the skin tissue in a time period of 3 to 60 minutes
3. Group 3 (minor danger)- caused visible necrosis of the skin tissue in 60 to 240 minutes - Irritation parameter:
- erythema score
- Basis:
- other: 3 animals
- Time point:
- other: 60 min and 4h
- Remarks on result:
- other: slight to moderate erythema
- Irritant / corrosive response data:
- No signs were observed at the 1-3 minute observation period. Slight to moderate erythema was observed at the 60 minute and 4 hour observation periods. Signs of necrosis were visible in one animal at the 4 hour observation period.
- Interpretation of results:
- other: minor damage
- Remarks:
- Criteria used for interpretation of results: other: International Civil Aviation Organization (ICAO) for Air Shipments
- Conclusions:
- The test substance was evaluated for dermal irritation. Based on the results the test substance was determined to produce minor damage.
- Endpoint:
- skin irritation / corrosion
- Remarks:
- no data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: No information on study design and methodology was presented.
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- No test item information provided
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): test substance as received - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- No information provided
- Details on study design:
- TEST SITE
- Type of wrap if used: Impervious patch
- Performed on intact and abraded skin and evaluated as per Draize protocol at 24 and 72 hours post dose.
SCORING SYSTEM: Draize
The maximum possible value for a skin reaction (excluding necrosis) is 4. The primary irritation score is the sum of the mean values divided by 4. - Interpretation of results:
- corrosive
- Remarks:
- Criteria used for interpretation of results: expert judgement
- Conclusions:
- The test substance is corrosive to the skin of the rabbit. Therefore, precautions should be observed to prevent skin contact with the product.
Referenceopen allclose all
Rabbit Number |
|||||||
24 hours |
1 |
2 |
3 |
4 |
5 |
6 |
Mean Score |
Intact skin |
|||||||
Erythema & Eschar |
4bw |
4bw |
4g |
4bwg |
4bwg |
4bwg |
4 |
Edema |
2 |
2 |
3 |
2 |
2 |
3 |
2.33 |
Abraded skin |
|||||||
Erythema & Eschar |
4bw |
4bw |
4g |
4bwg |
4bwg |
4bwg |
4 |
Edema |
2 |
2 |
3 |
2 |
3 |
3 |
2.5 |
72 hours |
1 |
2 |
3 |
4 |
5 |
6 |
Mean Score |
Intact skin |
|||||||
Erythema & Eschar |
4bs |
4bs |
4bw+ |
4bsw+ |
4bw+ |
4bwg |
4 |
Edema |
2 |
2 |
3 |
3 |
3 |
3 |
2.67 |
Abraded skin |
|||||||
Erythema & Eschar |
4bs |
4bs |
4bw+ |
4bsw+ |
4bw+ |
4bw+ |
4 |
Edema |
2 |
2 |
3 |
3 |
3 |
3 |
2.67 |
Sum of mean scores |
26.17 |
||||||
Primary Dermal Index |
6.54 |
||||||
Maximum Possible Score |
8.0 |
b=brown
g=greenish areas
s=slight eschar
w=white areas
+=moderate eschar
Based on the results, the test substance was classified as a Group 3 substance (producing minor danger).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978-12-26 to 1979-01-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Study conducted with methods similar to OECD Guideline 405. However, limited details were provided on the animals, environmental conditions and the test substance.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Limited details were provided on the animals, environmental conditions and the test substance.
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Name as cited in study report: Poly[oxy(methyl-1,2-ethanediyl)], alpha-(2-aminomethylethyl)-omega-(2-aminomethylethoxy)
- Substance type: Active
- Color: clear
- Date of receipt: 1978-11-3 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: The animals were housed two per cage in suspended wire mesh cages in a temperature controlled room reserved exclusively for rabbits on acute tests.
- Diet (e.g. ad libitum): ad libitum (fresh Purina Rabbit Chow)
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: at least one week
- Other: The animals were in good health when received from the local supplier and remained in good health during the equilibration period in the laboratory. The cages and room were kept clean in accordance with the standards of AAALAC of which the laboratory was an approved member. Prior to testing, the rabbits' eyes were closely examined for signs of irritation or damage. Only rabbit with healthy eyes were used. - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye of each animal served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of the test substance was instilled into one eye of each rabbit. The lids were held together briefly to insure adequate distribution of the test substance over the surface of the eye. - Duration of treatment / exposure:
- No data were provided in the study on washing the eye after treatment. The eyes were scored up for up to 14 days.
- Observation period (in vivo):
- 14 days (The ocular reactions were graded at 1, 24, 48 and 72 hours and again at 7 days. If any corneal score was present on day 7, the eyes were scored again at 14 days.)
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The study did not specify if washing was done.
SCORING SYSTEM: The eye irritation potential was determined as defined in 16 CFR 1500.3 and 1500.42. See below for scale used for scoring of ocular lesions (Draize, J.H. et al. J. Pharm. Exp. Ther. 82:377-390, 1944). - Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- ca. 41.3
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- ca. 55.7
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- ca. 66.6
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 61.4
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 7 d
- Score:
- ca. 57.3
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- ca. 72
- Max. score:
- 110
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- The test substance was corrosive to the rabbit eye.
- Other effects:
- One animal died during the study.
- Interpretation of results:
- corrosive
- Conclusions:
- The test substance was evaluated for eye irritation in New Zealand White rabbits. Based on the results, the test substance was determined to be corrosive to the eyes and considered to be classified as category 1 (serious eye damage) according to CLP Regulation.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: No information on study design and methodology was presented.
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- No test item information provided
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): used product as received - Duration of treatment / exposure:
- No information provided
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- No information provided
- Details on study design:
- SCORING SYSTEM: Draize
The maximum possible scores for eye irritation reactions (excluding necrosis) are: Cornea, 80; Iris, 10; Conjuctivae, 20. - Irritation parameter:
- other: corrosive; no irritation scores provided
- Reversibility:
- not reversible
- Remarks on result:
- other: corrosive within 24 hours of exposure
- Irritant / corrosive response data:
- Destruction or irreversible change of any tissue in 24 hours or less.
- Interpretation of results:
- corrosive
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test substance is corrosive to the eye of the rabbit. Therefore, precautions should be observed to prevent its introduction into or near eyes.
Referenceopen allclose all
Average Scores |
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
Cornea (max 80) |
18.3 |
30.0 |
40.8 |
34.2 |
35.0 |
54.0 |
Iris (max 10) |
5.0 |
6.7 |
7.5 |
9.2 |
5.0 |
0.0 |
Conjunctivae (max 20) |
18.0 |
19.0 |
18.3 |
18.0 |
17.3 |
18.0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In one skin irritation study of sufficient quality and tested with methods similar to OECD guideline 404, 0.5 mL test substance was applied to the intact skin of rabbits (Pharmakon research International Inc, 1982; Klimisch 2). Animals were observed at 4 and 44 hours after treatment. Signs of necrosis were visible in two of six rabbits at the 4 hour reading and in five of six rabbits at the 44 hour observation period.
In another skin irritation study tested with methods similar to OECD guideline 404 (MB Research Laboratories Inc, 1979; Klimisch 2). 0.5 mL test substance was applied to non-abraded and abraded skin of rabbits. Animals were observed at 24 and 72 hours after treatment. The primary dermal index was determined to be 6.54 indicating corrosivity.
In a skin irritation study conducted in methods comparable to OECD guideline 404, 0.5 ml test substance was applied directly on the intact skin sites (Pharmakon Research International Inc, 1984; Klimisch 2). Animals were observed at 3 and 60 minutes and 4 hours after treatment. No signs were observed at the 1-3 minute observation period. Slight to moderate erythema was observed at the 60 minute and 4 hour observation periods. Signs of necrosis were visible in one animal at the 4 hour observation period.
In a similar study, 0.5 mL test substance was applied to non-abraded and abraded skin of rabbits for 1 hour (American Cyanamid company, 1968; Klimisch 4). Animals were observed 72 hours after treatment. The primary dermal index was determined to be 6.4. The degree of second degree chemical burn was moderate and diffuse.
An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available.
Eye irritation
In one eye irritation study of sufficient quality and tested with methods similar to OECD guideline 405, 0.1 ml of the test substance was instilled into one eye of each rabbit (MB Research Laboratories Inc, 1979; Klimisch 2). The ocular reactions were graded at 1, 24, 48 and 72 hours and again at 7 days. If any corneal score was present on day 7, the eyes were scored again at 14 days. The maximum mean total scores (MMTs) were 41.3, 55.7, 66.6, 61.4, 57.3, and 72 at 1h, 24h, 48h, 72h, 7 day, and 14 day, respectively. Cornea and conjunctivae effects were not reversible within 14 days. The test substance was corrosive to rabbit eyes.
An in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available.
Justification for classification or non-classification
Based on the available data, a classification category 1C is warranted for skin irritation/corrosion.
Based on the available data, a classification category 1 (serious eye damage) is warranted for eye irritation.
No study is available on respiratory irritation. Data for classification is lacking.
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