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EC number: 947-407-8 | CAS number: -
- 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 report
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:
- Acute Dermal Irritation/corrosion Study of test chemical in Rabbits was performed as per OECD guideline No. 404.
- 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
- Molecular formula:
- C9H13N
- IUPAC Name:
- N, N-dimethyl-p-toluidine
- Test material form:
- liquid
- Details on test material:
- - Name of test material: N,N-dimethyl-p-toluidine- Molecular formula: C9H13N-- Molecular weight:135.165g/mol- Substance type: Organic- Batch number/ Lot no.: 18- Storage conditions : Room temperature (20 - 30 °C)- Physical state: Liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Procured from GENTOX Bio services., Hyderabad, India- Age at study initiation: 3 to 4 Months (Approximately)- Weight at study initiation: Minimum: 1.796 kg and Maximum: 1.998 kg (Prior to Treatment)- Housing: The animals were housed individually in stainless steel cages. - 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: 5 days (Animal No.-1) and 7 days (Animal No.-2 and 3)ENVIRONMENTAL CONDITIONS- Temperature (°C): Minimum: 19.60 °C, Maximum: 22.30 °C- Humidity (%): Minimum: 51.10 % , Maximum: 67.40 %- Air changes (per hr): More than 12 changes per hour- Photoperiod (hrs dark / hrs light): 12:12IN-LIFE DATES: From: To:
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 ml
- 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: Approximately 24 h prior to treatment, the fur coat of each rabbit was removed from dorsal lumbar region approximately 6 X 6 cm at contralateral sites on each rabbit using clipper, one as control and other site as treatment. Rabbits with healthy intact skin were selected for the study- % coverage: 6 X 6 cm- Type of wrap if used: porous gauze dressing and non-irritating tapeREMOVAL OF TEST SUBSTANCE- Washing (if done): cotton soaked in distilled water- Time after start of exposure: 4-hour exposure periodSCORING SYSTEM:Gradation as per draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1,2,3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Not irritating
- Irritation parameter:
- edema score
- Basis:
- animal: 1,2,3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: Not irritating
- 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 ObservationNo systemic toxicity was observed at treated rabbits during the experimental period. MortalityNo mortality was observed during the observation period.Body WeightsBody weights were increased as compared to day 0 in all the three animals at terminal sacrifice
Any other information on results incl. tables
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
Individual Animal Clinical Signs
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, under the experimental conditions tested it is concluded that the test chemical was Non-Irritating to the skin of female New Zealand White rabbits.
- Executive summary:
Acute Dermal Irritation/corrosion Study of test chemical in Rabbits was performed as per OECD guideline No. 404. Three healthy young adult female rabbits were used. 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 and0.5 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, 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.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 andvery 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 very slight erythema (barely perceptible) and no oedema was observed. At 48 and 72 hour no erythema and no oedema was observed. 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. 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, under the experimental conditions tested it is concluded that the test chemical was Non-Irritating to the skin of female New Zealand White rabbits.
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