N,N-dimethylaniline

Endpoint summary

Description of key information

The target chemical was found to be irritating to eyes but not irritating to skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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-dimethylaniline (CAS No. - 121-69-7) after topical application on the intact skin in rabbits.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Procured from RABBI ROOF, Hyderabad.
- Age at study initiation:3.5 to 4.5 Months (Approximately)
- Weight (Prior to Treatment):Minimum: 2.228 kg & Maximum: 2.502 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 8 days (Animal No.-2 and 3) prior to the application of the test item.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 20.00 °C and Maximum: 22.50 °C
- Humidity (%):Minimum: 47.20 % and Maximum: 68.40 %
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12

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:

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

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: At 24 hours

Score:

0.33

Max. score:

3

Reversibility:

no data

Remarks on result:

other: not irritating

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: At 24 hours

Score:

0.33

Max. score:

3

Reversibility:

no data

Remarks on result:

other: not irritating

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: At 24 hours

Score:

0

Max. score:

3

Reversibility:

no data

Remarks on result:

other: not irritating

Irritation parameter:

edema score

Basis:

animal: #1 ,#2 and #3

Time point:

other: At 24, 48 and 72 hours

Score:

0

Max. score:

3

Reversibility:

no data

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.

After 4 hours of exposure in Animal No. 1 and 2, there were very slight erythema (barely perceptible) and no oedema observed at 1 and 24 hour of observation which was recovered to normal at 48 hours observation.

In Animals Nos. 3 at 1 hour observation after post patch removal, revealed, slight erythema (barely perceptible) and no oedema which was recovered to normal at 24 hours.

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.33, 0.33, 0.00 and 0.00, 0.00, 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.

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	Left	1	1	0	0	0	0	0	0
2	Confirmatory	Left	1	1	0	0	0	0	0	0
3		Left	1	0	0	0	0	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	Right	0	0	0	0	0	0	0	0
2	Confirmatory	Right	0	0	0	0	0	0	0	0
3		Right	0	0	0	0	0	0	0	0

Key: h = Hour.

Erythema                                                                                                       Oedema

0 =No erythema                                                                                           0 =No oedema

Table 1 Continued…

Mean Individual Animal Score at 24, 48 and 72 hours

 

Animal Number                   Observations	1	2	3
Erythema	0.33	0.33	0.00
Oedema	0.00	0.00	0.00

 

 

 

Table 2

Individual Animal BodyWeight

Sex:Female

Animal No.	Body Weight (kg)
	Prior to Dosing	At termination
1	2.502	2.540
2	2.228	2.352
3	2.474	2.522

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:1 = Normal.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No erythema and oedema (skin irritation) were found at the end of 72 hour observation period after patch removal.
Hence, under the experimental test conditions, it was concluded that N, N-dimethylaniline (CAS No. - 121-69-7) was Non-Irritating to the skin of Female New Zealand White rabbits under the experimental conditions tested and being classified as “Category-Unclassified” as per CLP Regulation.

Executive summary:

Acute Dermal Irritation/corrosion Study of N, N-dimethylaniline (CAS No. - 121-69-7) in Rabbits, sponsored by Sustainability Support Services (Europe) AB was conducted at SA-FORD (Sanctuary for Research and Development), Maharashtra, India. 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) wasappliedto the skin,over an area of approximately 6 x 6 cm clippedof haironone 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, there was very slight erythema (barely perceptible) and no oedema observed at 1 and 24 hour of observation. At 48 and 72 hour observation, no erythema and oedema was observed in animal No 1.Hence the confirmatory test was conducted on additional two rabbits (No. 2 and 3)to confirm the non irritant nature of the test item.

The patch was removed after 4 hours and rabbits wereobservedfor erythema and oedemaat 1, 24, 48 and 72 hours after patch removal, evaluatedand graded as per draize method.

In Animals Nos. 2 at 1 and 24 hours observation after post patch removal, revealed, slight erythema (barely perceptible)and no oedema which was recovered to normal at 48 hours observation.

In Animals Nos. 3 at 1 hour observation after post patch removal, revealed, slight erythema (barely perceptible)and no oedema which was recovered to normal at 24 hours.

At 48 and 72 hours observation no Erythema and oedema post patch removal in Animal nos. 2 and 3.

The individual mean score at24, 48 and 72 hoursfor Animal Nos. 1, 2 and 3 were 0.33, 0.33, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.  

Hence, under the experimental test conditions,it was concluded thatN, N-dimethylaniline(CAS No. - 121-69-7) was Non-Irritating to the skin of female New Zealand White rabbits under the experimental conditions tested and Classified as “Category- Unclassified” as per CLP Regulation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

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

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

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.

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.

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

 

 

 

 

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation-

Based on studies of target substance reviewed for skin irritation from reliable sources having Klimisch rating1, 2 and 4 considering the weight of evidence approach.The summary of the results are presented below

Sr. No	End point	effect	Species	Remark
1.	Erythema and oedema score	Non irritating	Rabbit	Study report
2.	Overall irritation score	Non irritating	Rabbit	Publication
3.	Overall irritation score	Non irritating	Human	IUCLID Dataset
4.	Overall irritation score	Mildly irritating	Rabbit	Publication
5.	Overall irritation score	Mildly irritating	Rabbit	Publication

 

Based on results summarized in above table for the target chemicalN,N-dimethylanilineit can be concluded that the substance is not irritatingthe skin of rabbit and human. Also the experimental results shows that the target substance is not irritating to skin. The publication data shows the substance to be mildly irritating. However data is insufficient to classify the substance as an irritant. Thus N,N-dimethylaniline is considered to be non irritating to skin as per the criteria of CLP regulation.

Eye irritation:

Based on studies of target substance reviewed for eye irritation from reliable sources having Klimisch rating1, 2 and 4 considering the weight of evidence approach.The summary of the results are presented below-

Sr. No	End point	effect	Species	Remark
1.	Overall irritation score	Irritating	Rabbit	Study report
2.	Overall irritation score	Irritating	Rabbit	Publication
3.	Overall irritation score	Moderately irritating	Rabbit	RTECS

Based on results summarized in above table for the target chemicalN,N-dimethylanilineit can be concluded that the substance is irritatingthe eye of rabbit. The experimental results shows that the substance is irritating and is classified as an eye irritant in 'category 2' as per CLP regulation.  

Justification for selection of skin irritation / corrosion endpoint:

Under the experimental test conditions, it was concluded that N, N-dimethylaniline (CAS No. - 121-69-7) was Non-Irritating to the skin of Female

New Zealand White rabbits under the experimental conditions tested and being classified as “Category-Unclassified” as per CLP Regulation.

Justification for selection of eye irritation endpoint:

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.  

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Though the substance N,N-dimethylaniline shows moderate irritation to eye the same have not been considered as N,N-dimethylaniline has harmonised classification. Moreover the data do not specify any cofirmation for the classification of the substance in eye irritation category.

The substance was found to be a nonirritant to skin but classified for eye irritation in category 2 based on the experimental resulats and as per the CLP regulation.