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EC number: 204-493-5 | CAS number: 121-69-7
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Auto flammability
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
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- 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
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- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye 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-dimethylaniline (CAS No. - 121-69-7)” on eye, when exposed by the ocular route in rabbits.
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N-dimethylaniline
- EC Number:
- 204-493-5
- EC Name:
- N,N-dimethylaniline
- Cas Number:
- 121-69-7
- Molecular formula:
- C8H11N
- IUPAC Name:
- N,N-dimethylaniline
- Details on test material:
- - Name of test material (as cited in study report):N, N-dimethylaniline
- Molecular formula : C8H11N
- Molecular weight : 121.18 g/mol
- Substance type:Organic
- Physical state:Colourless Liquid
- Lot/batch No.:Lot 1/07
- Storage condition of test material:Stored in a cool place. Kept container tightly closed in a dry and well ventilated place.
- Other:
Handling and Disposal
Safety precautions : Avoided Contact with skin and eyes. Keep away from sources of ignition. Use aprons, masks, caps, gloves and goggles to ensure the health and safety of the personnel.
Disposal : The remaining unused test item was disposed as per internal SOPs of sa-FORD.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:Procured from Rabbiroof, Hyderabad, India.
- Age at study initiation:4.5 to 5.0 Months (Approximately)
- Weight at study initiation:Minimum: 2.042 kg and Maximum: 2.392 kg (Prior to Treatment)
- Health Status :Healthy young adult, Females were nulliparous and non pregnant.
- 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 10 days (Animal No. 2 and 3) prior to the application of the test item.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.50 °C and Maximum: 22.70 °C
- Humidity (%):Minimum: 41.20 % and Maximum: 67.30 %
- Air changes (per hr): More than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12:12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.1 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:
- 24 hrs
- Observation period (in vivo):
- All the animals were observed at 1, 24, 48, 72 hours and on day 7 after instillation of test item.
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):The treated eye of rabbit was washed with normal saline.
- Time after start of exposure:24 hours
SCORING SYSTEM:Draize Method
TOOL USED TO ASSESS SCORE: Ophthalmoscope and fluorescent strips.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: 24,48,72 hrs and 7 days
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Untreated (Control Eye)
- Irritation parameter:
- iris score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: 24,48,72 hrs and 7 days
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Untreated (Control Eye)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: 24,48,72 hrs and 7 days
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Untreated (Control Eye)
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: 24,48,72 hrs and 7 days
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Untreated (Control Eye)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 24, 48, 72 Hours and day 7
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eyes
- Irritation parameter:
- iris score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: After 24, 48, 72 Hours and day 7
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: After 24 Hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: After 48 Hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: After 72 Hours
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: Day 7
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Treated eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: After 24 Hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: After 48 Hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eye
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: After 72 Hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: For treated eyes
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1,#2 and #3
- Time point:
- other: Day 7
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other: Treated eyes
- Irritant / corrosive response data:
- The following were observed in treated rabbits.
In the initial test, 0.1 ml of test item was applied into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed no severe ocular lesions a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 ml of test item was instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Ocular lesions were seen in animal no. 2 and 3 at 1 hour observation which recovered at day 7.
Untreated eye of all the three rabbits was normal throughout the experimental period of 7 days.
The following grading scores were observed in treated eye of tested rabbits.
Observation at 1 hour after instillation of test item revealed: Cornea- No ulceration or opacity in all 3 animals; Area of Opacity- Zero in all the animals; Iris: Normal in all the animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) was observed in all the animals; Chemosis: Some swelling above normal (includes nictitating membranes) was seen in all 3 animals.
Observation at 24 hours after instillation of test item revealed: Cornea- No ulceration or opacity in all 3 animals; Area of Opacity- Zero was seen in all 3 animals; Iris: Normal in all the animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) was seen in animal no.1 whereas diffuse, crimson color; individual vessels not easily discernible was seen in animal no. 2 and 3; Chemosis: Some swelling above normal (includes nictitating membranes) was seen in all the animals.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 30 %, 30 % and 35 % damage in animal no. 1, 2 and 3 resectively.
Observation at 48 hours after instillation of test item revealed: Cornea- No ulceration or opacity in all 3 animals; Area of Opacity- No opacity was seen in all 3 animals; Iris: Normal in all the animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) was seen in animal no.1 whereas diffuse, crimson color; individual vessels not easily discernible was seen in animal no. 2 and 3; Chemosis: No swelling (Normal) was seen in all the animals.
Observation at 72 hours after instillation of test item revealed: Cornea- No ulceration or opacity in all 3 animals; Area of Opacity- No opacity was seen in all 3 animals; Iris: Normal in all the animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) was seen in animal no.1 and 3 whereas diffuse, crimson color; individual vessels not easily discernible was seen in animal no. 2; Chemosis: No swelling (Normal) was seen in all the animals.
Observation at day 7 after instillation of test item revealed: Cornea- No ulceration or opacity in all 3 animals; Area of Opacity- No opacity was seen in all 3 animals; Iris: Normal in all the animals. Conjunctivae - Blood vessels normal in all 3 animals; Chemosis: No swelling (Normal) was seen in all 3 animals.
The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 1.00, 0.33; 0.00, 0.00, 2.00, 0.33 and 0.00, 0.00, 1.67, 0.33, respectively. - Other effects:
- Clinical Observation
No systemic toxicity was observed in treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period.
Body weight
All the rabbits were observed with body weight gain on day 7 as compared to day 0.
Any other information on results incl. tables
Table 1 : Individual Animal Eye Irritation Scores
In Treated area Dose:0.1 ml of test item Sex:Female
Animal Numbers |
1 |
2 |
3 |
||||||||||||||||||||||||||||||||||
Application Side |
Right |
Right |
Right |
||||||||||||||||||||||||||||||||||
Eye Reactions |
At hour |
At hour |
At hour |
||||||||||||||||||||||||||||||||||
* |
1 |
24 |
48 |
72 |
Day 7 |
* |
1 |
24 |
48 |
72 |
Day 7 |
* |
1 |
24 |
48 |
72 |
Day 7 |
||||||||||||||||||||
Corneal Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||||||||||||||
Area of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||||||||||||||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||||||||||||||
Conjunctiva |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
1 |
2 |
2 |
2 |
0 |
0 |
1 |
2 |
2 |
1 |
0 |
|||||||||||||||||||
Chemosis |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
|||||||||||||||||||
Corneal Damage% |
30 |
30 |
35 |
Dose:Untreated (Control Eye) Sex:Female
Animal Numbers |
1 |
2 |
3 |
|||||||||||||||
Application Side |
Left |
Left |
Left |
|||||||||||||||
Eye Reactions |
At hour |
At hour |
At hour |
|||||||||||||||
* |
1 |
24 |
48 |
72 |
Day 7 |
* |
1 |
24 |
48 |
72 |
Day 7 |
* |
1 |
24 |
48 |
72 |
Day 7 |
|
Corneal Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Corneal Damage% |
0 |
0 |
0 |
Key:*= Pre-exposure eye examination.
Table 1 (Continued):Eye Irritation Scores - Mean Values after 24, 48, 72 Hours (Treated eye)
Animal No. Eye Reaction |
1 |
2 |
3 |
Corneal Opacity |
0.00 |
0.00 |
0.00 |
Iris |
0.00 |
0.00 |
0.00 |
Conjunctiva |
1.00 |
2.00 |
1.67 |
Chemosis |
0.33 |
0.33 |
0.33 |
Formula :
Mean Eye Irritation Score =
Sum of the Individual Animal Score for eye reactionat24, 48 and 72 hours
Number of the Observations (3)
Table 2: Individual AnimalClinicalSigns
Sex:Female
Animal No. |
Days (Post application observation) |
|||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key:1 = Normal
Table 3: Individual Animal Body Weight
Sex :Female
Animal No. |
Animal Body Weight (kg) |
|
Prior to application |
At termination |
|
1 |
2.392 |
2.510 |
2 |
2.158 |
2.396 |
3 |
2.042 |
2.316 |
Key:kg = Kilogram
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed within 7 days.
Hence, “N, N-dimethylaniline (CAS No. - 121-69-7) is “Mildly irritating to eyes” to New Zealand White Female rabbit eyes.Thus the substance “N, N-dimethylaniline (CAS No. - 121-69-7) is being classified as an eye irritant in 'category 2' as per CLP regulation. - Executive summary:
Acute Eye Irritation/Corrosion Study of “N, N-dimethylaniline (CAS No. - 121-69-7) in Rabbits, sponsored by Sustainability Support Services (Europe) ABwas conducted at sa-FORD (Sanctuary for Research and Development), Maharashtra, India. This study was performed as per OECD guideline no. 405.
Rabbits free from injury of eye were selected for the study. The eyes of all the rabbits were examined 24 hours prior to treatment. One eye of each rabbit served as control and other as treated. Control eye was left untreated whereas; 0.1 mlof test itemwas instilled in the other (treated) eye of each rabbit.The eye was observed at 1, 24, 48, 72 hours and on day 7 after test item instillation.Ophthalmoscope was used for scoring of eye lesions.
In the initial test,0.1 ml of test itemwas applied into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. As animal no. 1 showed no severe ocular lesions a confirmatory test was conducted on additional two rabbits (animal no. 2 and 3); 0.1 mlof test itemwas instilled into the conjunctival sac of right eye of both the rabbits and left eye served as the control. Ocular lesions were seen in animal no. 2 and 3 at 1 hour observation which recovered at day 7.
Untreated eye of all the three rabbits was normal throughout the experimental period of 7 days.
The following grading scores were observed in treated eye of tested rabbits.
Observation at 1 hour after instillation of test item revealed: Cornea-No ulceration or opacity in all 3 animals; Area of Opacity-Zero in all the animals;Iris:Normal in all the animals.Conjunctivae -Some blood vessels definitely hyperaemic (injected) was observed in all 3 animals;Chemosis:Some swelling above normal (includes nictitating membranes) was seen in all 3 animals.
Observation at 24 hours after instillation of test item revealed: Cornea-No ulceration or opacity in all 3 animals; Area of Opacity- Zero was seen in all 3 animals;Iris:Normal in all the animals.Conjunctivae -Some blood vessels definitely hyperaemic (injected) was seen in animal no.1 whereas diffuse, crimson color; individual vessels not easily discernible was seen in animal no. 2 and 3;Chemosis:Some swelling above normal (includes nictitating membranes) was seen in all 3 animals.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 30 %, 30 % and 35 % damage in animal no. 1, 2 and 3 resectively.
Observation at 48 hours after instillation of test item revealed: Cornea-No ulceration or opacity in all 3 animals; Area of Opacity-No opacity was seen in all 3 animals;Iris:Normal in all the animals.Conjunctivae -Some blood vessels definitely hyperaemic (injected) was seen in animal no.1 whereas diffuse, crimson color; individual vessels not easily discernible was seen in animal no. 2 and 3;Chemosis:No swelling (Normal) was seen in all 3 animals.
Observation at 72 hours after instillation of test item revealed: Cornea-No ulceration or opacity in all 3 animals; Area of Opacity-No opacity was seen in all 3 animals;Iris:Normal in all the animals.Conjunctivae -Some blood vessels definitely hyperaemic (injected) was seen in animal no.1 and 3 whereas diffuse, crimson color; individual vessels not easily discernible was seen in animal no. 2;Chemosis:No swelling (Normal) was seen in all the animals.
Observation at day 7 after instillation of test item revealed: Cornea-No ulceration or opacity in all 3 animals; Area of Opacity-No opacity was seen in all 3 animals;Iris:Normal in all the animals.Conjunctivae -Blood vessels normal in all 3 animals;Chemosis:No swelling (Normal) was seen in all 3 animals.
The individual mean score for animal nos. 1, 2 and 3at 24, 48, 72 hoursfor corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 1.00, 0.33; 0.00, 0.00, 2.00, 0.33 and 0.00, 0.00, 1.67, 0.33, respectively.
Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbit no. 2 and 3 was observed at 24 hours.
Hence under the experimental test conditions,“N, N-dimethylaniline(CAS No. - 121-69-7) is “Mildly Irritating to Eyes” to New Zealand White female rabbit eyes.Under the experimental conditions tested, eye irritation and reversibility of effects on eyes of rabbits was observed within 7 days.Hence, “N, N-dimethylaniline (CAS No. - 121-69-7) is “Mildly irritating to eyes” to New Zealand White Female rabbit eyes.Thus the substance “N, N-dimethylaniline (CAS No. - 121-69-7) is being classified as an eye irritant in 'category 2' as per CLP regulation.
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