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EC number: 202-088-8 | CAS number: 91-66-7
- 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:
- key study
- 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:
- The objective of the study was to assess the irritant and/or corrosive effects of test chemical after dermal application on the intact skin in rabbits.
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N-diethylaniline
- EC Number:
- 202-088-8
- EC Name:
- N,N-diethylaniline
- Cas Number:
- 91-66-7
- Molecular formula:
- C10H15N
- IUPAC Name:
- N,N-diethylaniline
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report):N, N-diethylaniline
- Molecular formula :C8H11N
- Molecular weight :121.18 g/mol
- Substance type:Organic
- Physical state:clear light yellow oily liquid
- Lot/batch No.:Lot 1/07
- Storage condition of test material:Store in a cool place. Keep container tightly closed in a dry and well ventilated place.
- Other:
Handling and Disposal
Safety precautions : Avoid Contact with skin and eyes. Keep away from sources of ignition. Aprons, masks, caps, gloves and goggles were used to ensure the health and safety of the personnel.
Disposal : The remaining unused test item was disposed as per internal SOPs.
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 LIVEON BIOLABS PVT. LTD
- Age at study initiation:3.0 to 4.0 Months (Approximately)
- Weight (Prior to Treatment):Minimum: Minimum: 2.082 kg and Maximum: 2.250 kg
- Health Status : Healthy young adults 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 6 days (Animal No.-1) and 8 days (Animal No.-2 and 3) prior to the application of the test item.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 20.30 °C and Maximum: 22.70 °C
- Humidity (%):Minimum: 48.30 % and Maximum: 68.30 %
- 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:
- not specified
- Controls:
- yes
- 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:
- rabbits were observed for 1, 24, 48, 72 hr and 7th day after patch removal
- Number of animals:
- 3 male 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:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- The following were observed in treated rabbits.
Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch. At 1 hour observation animal no. 1 revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible). At 24 hour observation well defined erythema and slight oedema (edges of area well defined by definite raising) was observed. After 24 hours no severe skin lesions were observed hence a confirmatory test was conducted on additional two rabbits (No. 2 and 3) to confirm the irritant nature of the test item. At 48 hour observation, well defined erythema and slight oedema (edges of area well defined by definite raising) was observed. At 72 hour observation, very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. Animal no.1 was recovered to normal on day 7.
Animal no. 2 and 3 revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) at 1 hour observation. At 24 and 48 hour observation animal no. 2 and 3 revealed well defined erythema and slight oedema (edges of area well defined by definite raising). At 72 hour observation, animal no. 2 revealed well defined erythema and very slight oedema (barely perceptible). At 24, 48 and 72 hour observation, animal no. 3 revealed well defined erythema and slight oedema (edges of area well defined by definite raising). Animal no.2 and 3 recovered to normal on day 7.
The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method. - 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:Male
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||||
1h |
24h |
48h |
72h |
Day 7 |
1h |
24h |
48h |
72h |
Day 7 |
|||
1 |
Initial |
Left |
1 |
2 |
2 |
2 |
0 |
1 |
2 |
2 |
1 |
0 |
2 |
Confirmatory |
Right |
1 |
2 |
2 |
2 |
0 |
1 |
2 |
2 |
1 |
0 |
3 |
Right |
1 |
2 |
2 |
2 |
0 |
1 |
2 |
2 |
2 |
0 |
In Control area Dose:0.5 ml of distilled water Sex:Male
Animal No. |
Test |
Treated area* |
Erythema score |
Oedema score |
||||||||
1h |
24h |
48h |
72h |
Day 7 |
1h |
24h |
48h |
72h |
Day 7 |
|||
1 |
Initial |
Right |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
Confirmatory |
Left |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
Left |
0 |
0 |
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 2 = Slight oedema (edges of defined by definite raising
Table 1 Continued…
Mean Individual Animal Score at 24, 48 and 72 hours
Animal Number Observations |
1 |
2 |
3 |
Erythema |
2.00 |
2.00 |
2.00 |
Oedema |
1.67 |
1.67 |
2.00 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 2.00, 2.00, 2.00 and 1.67, 1.67, 2.00, for erythema and oedema formation, respectively. Hence, it was concluded that the test chemical was Mild Skin Irritation to the skin of Male New Zealand White rabbits under the experimental conditions tested and classified as “Category 2 (irritant)” as per CLP regulation.
- Executive summary:
Acute Dermal Irritation/corrosion Study of test chemical was performed as per OECD guideline No. 404 using three healthy young adult male.
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 of 0.5 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. At 1 hour observation animal no. 1 revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible). At 24 hour observation well defined erythema and slight oedema (edges of area well defined by definite raising) was observed. After 24 hours no severe skin lesions were observed hence a confirmatory test was conducted on additional two rabbits (No. 2 and 3) to confirm the irritant nature of the test item. At 48 hour observation, well defined erythema and slight oedema (edges of area well defined by definite raising) was observed. At 72 hour observation, very slight erythema (barely perceptible) and very slight oedema (barely perceptible) was observed. Animal no.1 was recovered to normal on day 7.
Animal no. 2 and 3 revealed very slight erythema (barely perceptible) and very slight oedema (barely perceptible) at 1 hour observation. At 24 and 48 hour observation animal no. 2 and 3 revealed well defined erythema and slight oedema (edges of area well defined by definite raising). At 72 hour observation, animal no. 2 revealed well defined erythema and very slight oedema (barely perceptible). At 24, 48 and 72 hour observation, animal no. 3 revealed well defined erythema and slight oedema (edges of area well defined by definite raising). Animal no.2 and 3 recovered to normal on day 7.
The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method.
The individual mean score at24, 48 and 72 hours for animal nos. 1, 2 and 3 were 2.00, 2.00, 2.00 and The individual mean score at 24, 48 and 72 hours for animal nos. 1, 2 and 3 were 2.00, 2.00, 2.00 and 1.67, 1.67, 2.00, for erythema and oedema formation, respectively.
Hence, it was concluded that the test chemical was Mild Skin Irritation to the skin of Male New Zealand White rabbits under the experimental conditions tested and classified as “Category 2 (irritant)” as per CLP regulation.
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