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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
Oral: LD50 (rat) = 959 mg/kg bw
Dermal: LD50 (rat) > 2000 mg/kg bw (based on read-across)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Necropsy was not performed.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 1987
- Deviations:
- yes
- Remarks:
- Necropsy was not performed.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Wistar TNO W 74
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 weeks (males); 14 weeks (females)
- Weight at study initiation: 166 - 189 g (males); 168 - 192 g (females)
- Housing: 5 animals/group were housed in macrolon typ III cages with wood granulat as bedding material
- Diet: Altromin R 1324 (Altromin GmbH, Lage, Germany), ad libitum
- Water: Tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DOSAGE PREPARATION:
The test substance was slightly heated prior to administration. - Doses:
- 0.1, 0.5, 1.0, 1.5, 2.0 and 2.5 mL/kg bw (equivalent to 109, 545, 1090, 1635, 2180 and 2725 mg/kg bw)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for signs of toxicity and mortality several times on the day of administration, twice daily thereafter and once daily on weekends and public holidays. The body weight was recorded prior to the administration and thereafter once weekly.
- Necropsy of survivors performed: no - Statistics:
- Probit analysis was used for the calculation of the LD50 value.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 0.88 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Probit analysis
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 959 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: by calculation using a density of 1.09 g/cm³
- Mortality:
- 109 mg/kg bw: no mortality occurred.
545 mg/kg bw: 2/5 males and 1/5 females died 1 h post-administration.
1090 mg/kg bw: 3/5 males and 2/5 females died 1 h post-administration.
1635 mg/kg bw: 4/5 males and 3/5 females died 1 h post-administration.
2180 mg/kg bw: 5/5 males and 3/5 females died 1 day post-administration.
2725 mg/kg bw: 3/5 males died on Day 2 and 2/5 males died on Day 3 after administration of the test substance, respectively. All females died on Day 1 after administration of the test substance. - Clinical signs:
- other: 109 mg/kg bw: no clinical signs occured in all animals. 545 mg/kg bw: tremor, convulsions and a decline in general conditions were observed in all males and females 10 min after administration of the test substance. These effects persisted in 3/5 males up
- Gross pathology:
- Necropsy was not performed.
- Interpretation of results:
- other: CLP/EU GHS Category 4, H302 according to Regulation (EC) No. 1272/2008.
- Conclusions:
- In an acute oral toxicity study with rats, performed similar to OECD 401, a LD50 of 959 mg/kg bw was determined.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 959 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate, reliable (Klimisch score 2) and consistent study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- In an acute dermal toxicity study with rats, performed according to OECD/EC test guidelines, an LD50 >2000 mg/kg bw was determined for the source substance Reaction mass of 2,2'-[(4-methylphenyl)imino]bisethanol and Ethanol 2-[[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino]- (EC 911-490-9). Applying the read-across approach, similar results are expected for the target substance N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products and similarities in PC/ECO/TOX properties. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Additional information
Acute oral toxicity
There are reliable data available regarding acute oral toxicity for N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1).
An acute oral toxicity test was conducted with five male and five female Wistar TNO W 74 rats similar to OECD 401 (Bayer AG, 1981). The test substance was slightly heated prior to administration, and thereafter administered unchanged at dose levels of 0.1, 0.5, 1.0, 1.5, 2.0 and 2.5 mL/kg bw (equivalent to 109, 545, 1090, 1635, 2180 and 2725 mg/kg bw) via gavage. Mortality occurred at a dose level ≥ 545 mg/kg bw. Tremor, convulsions and a decline in general conditions were observed at 545, 1090 and 1635 mg/kg bw in all males and females 10 min after administration of the test substance. At higher dose levels (2180 and 2725 mg/kg bw) tremor, convulsions, a decline in general conditions, cyanosis and lateral and abdominal position were noted in all males and females 10 min after administration of the test substance. Necropsy was not performed. Based on the observed results, a LD50 of 959 mg/kg bw was determined.
A second acute oral toxicity test was available and used as supporting information. In this study 2 male cats/dose level were treated with 10 and 50 mL N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1) per kg bw in Lutrol via gavage (Bayer AG, 1985). Clinical signs such as a decline of the general condition, anorexia, narcosis, respiratory dysfunction, mydriasis and spasms were observed after administration with the test substance at both dose levels. At the low dose level, no mortality occurred. At 50 mL/kg bw 2/2 animals died 3 h after administration with the test substance, therefore the LD100 was considered to be 50 mL/kg bw.
Acute dermal toxicity
As there is no data available regarding acute dermal toxicity for N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1), read-across from an appropriate structural analogue substance is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.5. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13). For acute dermal toxicity information from the analogue substance Reaction mass of 2,2'-[(4-methylphenyl)imino]bisethanol and 2-[[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino]-ethanol (EC 911-490-9) will be taken into account to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.5.
EC 911-490-9
An acute dermal toxicity test was conducted with five male and five female rats following OECD 402 and according to GLP principles with the source substance Reaction mass of 2,2'-[(4-methylphenyl)imino]bisethanol and 2-[[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino]-ethanol (EC 911-490-9) (WIL Research, 2013a). The test substance was applied occlusive at 2000 mg/kg bw for 24 h. No mortality occurred. No unexpected changes in body weight gain were reported. Hunched posture, piloerection and/or chromodacryorrhoea were noted in all males and three females on Days 1 and/or 2. Hypothermia was noted in one male on Day 2. 2/5 males showed many reddish foci in the thymus and 3/5 females showed enlarged size of mandibular lymph nodes during macroscopic post mortem examination. No abnormalities were found in the other animals. Based on these results, the test substance has an acute dermal LD50 > 2000 mg/kg bw. Similar results are expected for the target substance N,N-Dihydroxyethyl-p-toluidine (CAS 3077-12-1).
The available data with the registration substance on acute oral toxicity meet the classification criteria as Acute oral Tox. 4, H302 according to Regulation (EC) 1272/2008. The available data with a structural similar substance on acute dermal toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
Justification for classification or non-classification
The available target substance data on acute oral toxicity meet the classification criteria as Acute oral Tox. 4, H302 according to Regulation (EC) 1272/2008. The available source substance data on acute dermal toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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.
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