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EC number: 221-359-1 | CAS number: 3077-12-1
- 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 (in vivo): not irritant
Eye irritation (in vivo): severe eye damage
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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16. Section 1500.41
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Germany
- Weight at study initiation: 2.4 kg
- Housing: Animals were individually housed.
- Diet: Mümmel z (ssniff, Soest, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 7 -14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Remarks:
- left flank of each animal was intact; right flank of each animal was abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 24 h
Reading time points: approximately 30 min after removal of the test substance (24-h reading time point) and 48 (72-h reading time point) and 72 h after start of the experiment - Observation period:
- 8 d
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: The treated skin was covered with a gauze, held in place with a PVC foil and Leukoflex® adhesive plaster. The whole body of the animal was wrapped with elastic Eloflex® during the exposure period.
SCORING SYSTEM:
- Method of calculation: Draize Scoring system - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- individual score of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- edema score
- Basis:
- animal: #2, #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal: #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- The dermal application of the test substance did not result in erythema in any of the animals tested at any observation time point. Thus, the erythema score for all animals was 0 over 24, 48 and 72 h, respectively. 1/6 animals showed a slight edema 24 h (grade 2) and 72 h (grade 1) after the test substance application, respectively, which was fully reversible within 8 days, resulting in an edema score of 1.66 over 24, 48 and 72 h, respectively. 2/6 animals showed slight edema (grade 1) at the 24-h reading time point. At the 72-h reading time point the dermal effect was completely reversible, resulting in an edema score of 0.66 for both animals over 24, 48 and 72 h, respectively. In 3/6 animals the dermal application of the test substance did not result in edema in at any observation time point.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- Based on the results of this study, no skin irritating properties were determined in rabbits after dermal application of the test substance.
Reference
Table 1. Results of skin irritation study
Observation time | Rabbit no. | |||||||||||
1 | 2 | 3 | 4 | 5 | 6 | |||||||
Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | |
24 h | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
48 h | No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption) | |||||||||||
72 h | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Table 2. Calculation of mean scores
Rabbit no. | ||||||||||||
1 | 2 | 3 | 4 | 5 | 6 | |||||||
Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | Erythema | Edema | |
Mean value 24 + 48 + 72 h* | 0,00 | 1,67 | 0,00 | 0,00 | 0,00 | 0,00 | 0,00 | 0,00 | 0 | 0,67 | 0,00 | 0,67 |
*No 48 h data are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).
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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2017
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Germany
- Weight at study initiation: 2.4 kg
- Housing: Animals were individually housed.
- Diet: Mümmel z (ssniff, Soest, Germany), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 7 -14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 8 d
Reading time points: 24, 48 and 72 h and 8 d - Number of animals or in vitro replicates:
- 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: No washing was performed
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #4 and #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal: #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 and #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days in animal #2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #4 and #5
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days in animal #2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #4 and #5
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Irritant / corrosive response data:
- 24 h after exposure, chemosis (grade 1 or 2) was observed in all animals, which did not disappear in 5/6 animals up to the end of the observation period. The chemosis scores were 1.0 (2/6 animals), 1.3 (1/6 animals), 1.7 (2/6 animals) and 2.0 (1/6 animals) over 24, 48 and 72 h, respectively. All 6 animals showed redness of the conjunctivae (grade 1 or 2), which did not disappear in 5/6 animals up to the end of the observation period. The conjunctivae scores were 1.0 (3/6 animals), 1.7 (2/6 animals) and 2.0 (1/6 animals) over 24, 48 and 72 h, respectively. Adverse effects on the cornea (score 1 or 2) and the iris (score 1 or 2) were observed in all animals, which were not completely reversible up to the end of the observation period. The cornea opacity score of 1.0 and 1.3 was determined for 5/6 and 1/6 animals over 24, 48 and 72 h, respectively. The iris score was 1.3 for 4/6 animals and 1.0 for 2/6 animals over 24, 48 and 72 h, respectively.
- Interpretation of results:
- other: CLP/EU GHS Category 1, H318 according to Regulation (EC) No. 1272/2008.
- Conclusions:
- The observation period in the conducted study was shorter than recommended in the recent OECD 405. Since the observed effects were not completely reversible up to the end of the observation period of 8 days, the test substance was considered to have a corrosive potential towards the eyes.
Reference
Table 1. Results of eye irritation study
Rabbit # | Time | conjunctivae | iris | cornea | |
redness | swelling | ||||
1 | 24 h | 1 | 1 | 2 | 1 |
48 h | 1 | 1 | 1 | 1 | |
72 h | 1 | 1 | 1 | 1 | |
average 24/48/72 h | 1 | 1 | 1.3 | 1 | |
8 days | 0 | 0 | 1 | 1 | |
2 | 24 h | 1 | 1 | 2 | 1 |
48 h | 1 | 1 | 1 | 1 | |
72 h | 1 | 1 | 1 | 1 | |
average 24/48/72 h | 1 | 1 | 1.3 | 1 | |
8 days | 1 | 1 | 1 | 1 | |
3 | 24 h | 1 | 2 | 1 | 1 |
48 h | 1 | 1 | 1 | 1 | |
72 h | 1 | 1 | 1 | 1 | |
average 24/48/72 h | 1 | 1.3 | 1 | 1 | |
8 days | 0 | 1 | 1 | 1 | |
4 | 24 h | 2 | 2 | 1 | 1 |
48 h | 2 | 2 | 1 | 1 | |
72 h | 1 | 1 | 1 | 1 | |
average 24/48/72 h | 1.7 | 1.7 | 1 | 1 | |
8 days | 1 | 1 | 1 | 1 | |
5 | 24 h | 2 | 2 | 1 | 1 |
48 h | 2 | 2 | 1 | 1 | |
72 h | 1 | 1 | 1 | 1 | |
average 24/48/72 h | 1.7 | 1.7 | 1 | 1 | |
8 days | 1 | 1 | 1 | 1 | |
6 | 24 h | 2 | 2 | 1 | 2 |
48 h | 2 | 2 | 1 | 1 | |
72 h | 2 | 2 | 1 | 1 | |
average 24/48/72 h | 2 | 2 | 1 | 1.3 | |
8 days | 1 | 1 | 1 | 1 | |
Time [h] | conjunctivae | iris | cornea | ||
redness | swelling | ||||
Mean of 6 animals | 24 | 1.5 | 1.67 | 1.33 | 1.17 |
48 | 1.5 | 1.5 | 1 | 1 | |
72 | 1.17 | 1.17 | 1 | 1 | |
24+48+72 | 1.39 | 1.44 | 1.11 | 1.06 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
An in vivo skin irritation study according to Code of Federal Regulations, Title 16, Section 1500.41 was available and used to assess the skin irritation potential of the target substance N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1) (Fraunhofer Institut, 1981a). In this study 0.5 mL of the unchanged test substance was applied on the dorsal back each of 6 NZW rabbits under occlusive conditions for 24 h. The animals were observed approximately 30 min after removal of the test substance (24-h reading time point) and 48 (72-h reading time point) and 72 h after start of the experiment. Scoring of skin findings was done according to the Draize scorring system. The dermal application of the test substance did not result in erythema in any of the animals tested at any observation time point. Thus, the erythema score for all animals was 0 over 24, 48 and 72 h, respectively. 1/6 animals showed a slight edema 24 h (grade 2) and 72 h (grade 1) after the test substance application, respectively, which was fully reversible within 8 days, resulting in an edema score of 1.66 over 24, 48 and 72 h, respectively. 2/6 animals showed slight edema (grade 1) at the 24-h reading time point. At the 72-h reading time point the dermal effect was completely reversible, resulting in an edema score of 0.66 for both animals over 24, 48 and 72 h, respectively. In 3/6 animals the dermal application of the test substance did not result in edema in at any observation time point. Based on these results, the test substance was not considered to show an irritation potential to the skin.
Eye
To evaluate the irritation potential towards the eyes of N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1), an in vivo study performed according to Code of Federal Regulations, Title 16, Section 1500.42 was evaluated. In this study, 0.1 mL (unchanged) of the test substance (CAS 3077-12-1) was instilled into the eyes of 6 male white rabbits (NZW) (Fraunhofer Institut, 1981b). The treated eyes remained unwashed and were observed 24, 48 and 72 h and 8 d after treatment. Scoring of eye findings was done according to the Draize scoring system. 24 h after exposure, chemosis (grade 1 or 2) was observed in all animals, which did not disappear in 5/6 animals up to the end of the observation period. The chemosis scores were 1.0 (2/6 animals), 1.3 (1/6 animals), 1.7 (2/6 animals) and 2.0 (1/6 animals) over 24, 48 and 72 h, respectively. All 6 animals showed redness of the conjunctivae (grade 1 or 2), which did not disappear in 5/6 animals up to the end of the observation period. The conjunctivae scores were 1.0 (3/6 animals), 1.7 (2/6 animals) and 2.0 (1/6 animals) over 24, 48 and 72 h, respectively. Adverse effects on the cornea (score 1 or 2) and the iris (score 1 or 2) were observed in all animals, which were not completely reversible up to the end of the observation period. The cornea opacity score of 1.0 and 1.3 was determined for 5/6 and 1/6 animals over 24, 48 and 72 h, respectively. The iris score was 1.3 for 4/6 animals and 1.0 for 2/6 animals over 24, 48 and 72 h, respectively. Based on the results of the conducted study, N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1) is considered to reveal severe eye damage.
The available data with the registration substance regarding skin irritation/corrosion do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification. However, the available data regarding eye irritation meet the classification criteria for Eye Damage 1, H318 according to Regulation (EC) 1272/2008.
Justification for classification or non-classification
The available target substance data regarding skin irritation/corrosion do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification. The available target substance data regarding eye irritation meet the classification criteria for Eye Damage 1, H318 according to Regulation (EC) 1272/2008.
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