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EC number: 264-355-5 | CAS number: 63589-47-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- data is from experimental reports
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The objective of the study was to assess the irritant and/or corrosive effects of N, N-dimethyl-p-toluidine (CAS No. – 99-97-8) after dermal application on the intact skin in rabbits.
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N-dimethyl-p-toluidine
- EC Number:
- 202-805-4
- EC Name:
- N,N-dimethyl-p-toluidine
- Cas Number:
- 99-97-8
- IUPAC Name:
- N,N,4-trimethylaniline
- Details on test material:
- IUPAC name: N,N-dimethyl-p-toluidine
Molecular formula: C9H13N
Molecular weight: 135.209 g/mole
Smiles: c1(N(C)C)ccc(C)cc1
InChI: 1S/C9H13N/c1-8-4-6-9(7-5-8)10(2)3/h4-7H,1-3H3
Constituent 1
- Specific details on test material used for the study:
- IUPAC name: N,N-dimethyl-p-toluidine
Molecular formula: C9H13N
Molecular weight: 135.209 g/mole
Smiles: c1(N(C)C)ccc(C)cc1
InChI: 1S/C9H13N/c1-8-4-6-9(7-5-8)10(2)3/h4-7H,1-3H3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: Female
- Source:Procured from RABBI ROOF, Hyderabad.
- Age at study initiation:4 to 5 Months (Approximately).
- Weight (Prior to Treatment):Minimum: 1.914 kg and Maximum: 2.358 kg
- Health Status :Healthy young adults and nulliparous and non-pregnant Rabbits were used for the study.
- Housing:The animals were housed individually in stainless steel cages.
- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle:All the cages and water bottles were changed minimum twice a week.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum.
- Acclimation period:Rabbits were acclimatised to the test conditions for a period of 5 days (Animal No.-1) and 10 days (Animal No.-2 and 3) prior to the application of the test item.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.30 °C and Maximum: 22.50 °C
- Humidity (%):Minimum: 43.80 % and Maximum: 68.40 %
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml
- Concentration (if solution):N/A
VEHICLE
- Amount(s) applied (volume or weight with unit):N/A
- Concentration (if solution):N/A
- Lot/batch no. (if required):N/A
- Purity:N/A - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure:The dorsal lumbar region at contralateral sites.
- % coverage:Approximately 6 X 6 cm.
- Type of wrap if used:A porous gauze dressing and non-irritating tape (Micropore 3”).
REMOVAL OF TEST SUBSTANCE
- Washing (if done):The residual test item was removed by using cotton soaked in distilled water.
- Time after start of exposure:4 hour
SCORING SYSTEM:Draize Method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- no data
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- no data
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The following were observed in treated rabbits.
The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours after patch removal, evaluated and graded as per draize method.
Animal No. 1, very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation. At 24 hour very slight erythema (barely perceptible) and no oedema was observed. At 48 and 72 hours observation no erythema and no oedema was observed in animal no 1.
Animal No. 2, revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation post patch removal. At 24 hour well defined erythema and very slight oedema (barely perceptible) was observed. At 48 hour very slight erythema (barely perceptible) and no oedema was observed. At 72 hour no erythema and no oedema was observed. Animal No. 3, revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation post patch removal. At 24 hour slight erythema (barely perceptible) and no oedema was observed. At 48 and 72 hour no erythema and no oedema was observed.
The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 0.33, 1.00, 0.33 and 0.00, 0.33, 0.00, for erythema and oedema formation, respectively. - Other effects:
- Clinical Observation
No systemic toxicity was observed at treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period.
Any other information on results incl. tables
Table 1
Skin Reaction
In Treated area Dose:0.5 ml of test item Sex:Female
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
|||
1 |
Initial |
Right |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
Confirmatory |
Right |
1 |
2 |
1 |
0 |
1 |
1 |
0 |
0 |
3 |
Right |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
In Control area Dose:0.5 ml of distilled water Sex:Female
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
|||
1 |
Initial |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Confirmatory |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Key:h = Hour.
Erythema Oedema
0 =No erythema 0 =No oedema
1 = Very slight erythema (barely perceptible) 1 = Very slight oedema(barely perceptible)
Table 1
Skin Reaction
In Treated area Dose:0.5 ml of test item Sex:Female
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
|||
1 |
Initial |
Right |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
Confirmatory |
Right |
1 |
2 |
1 |
0 |
1 |
1 |
0 |
0 |
3 |
Right |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
In Control area Dose:0.5 ml of distilled water Sex:Female
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
|||
1 |
Initial |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Confirmatory |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Key:h = Hour.
Erythema Oedema
0 =No erythema 0 =No oedema
1 = Very slight erythema (barely perceptible) 1 = Very slight oedema(barely perceptible)
2 = Well defined erythema
Mean Individual Animal Score at 24, 48 and 72 hours
Animal Number Observations |
1 |
2 |
3 |
Erythema |
0.33 |
1.00 |
0.33 |
Oedema |
0.00 |
0.33 |
0.00 |
Individual Animal BodyWeight
Sex:Female
Animal No. |
Body Weight (kg) |
|
Prior to Dosing |
At termination |
|
1 |
1.796 |
1.856 |
2 |
1.940 |
1.992 |
3 |
1.998 |
2.110 |
Key: kg = kilogram
Table 3 Individual AnimalClinicalSigns
Sex:Female
Animal No. |
Days (Post dosing Observation) |
|||
0 |
1 |
2 |
3 |
|
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
Key: ./. = Not Applicable. 1 = Normal
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 0.33, 1.00, 0.33 and 0.00, 0.33, 0.00, for erythema and oedema formation, respectively.
Hence, it was concluded that “N, N-dimethyl-p-toluidine (CAS No. – 99-97-8)” was Non-Irritating to the skin of Female New Zealand White rabbits under the experimental conditions tested and Classified as “Category- Not Classified” as per CLP Regulation. - Executive summary:
Acute Dermal Irritation/corrosion Study of “N, N-dimethyl-p-toluidine (CAS No. – 99 -97 -8)”in Rabbits, was performed in a OECD GLP laboratory (Sustainability Support Services (Europe) AB has the letter of access). This study was performed as per OECD guideline No. 404.
Three healthy young adult female rabbits were used for conducting acute dermal irritation study. Body weights were recorded on day 0 (prior to application) and at termination. Rabbits with good intact skin were selected for the study. The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A dose of0.5 ml of test item (as such) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and 0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with water without altering the integrity of the epidermis. Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch. After 4 hours of exposure in Animal No. 1, there was very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation. At 24 hour very slight erythema (barely perceptible) and no oedema was observed.Hence the confirmatory test was conducted after 24 hours on additional two rabbits (No. 2 and 3)to confirm the non-irritant nature of the test item.
Animal No. 2, revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation post patch removal. At 24 hour well defined erythema and very slight oedema (barely perceptible) was observed. At 48 hour very slight erythema (barely perceptible) and no oedema was observed. At 72 hour no erythema and no oedema was observed. Animal No. 3, revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) observed at 1 hour of observation post patch removal. At 24 hour slight erythema (barely perceptible) and no oedema was observed. At 48 and 72 hour no erythema and no oedema was observed.
The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 0.33, 1.00, 0.33 and 0.00, 0.33, 0.00, for erythema and oedema formation, respectively.
Hence, it was concluded that “N, N-dimethyl-p-toluidine (CAS No. – 99-97-8)” was Non-Irritating to the skin of Female New Zealand White rabbits under the experimental conditions tested and Classified as “Category- Not Classified” as per CLP Regulation.
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