N-ethylmethacrylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8-15 October 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Data presented as a summary report to TSCA under the Section 8 (e) Compliance Audit Programme for Reportable Adverse Effects. A full study report is not available for evaluation of the overall study reliability but the data summary presented to TSCA is adequate to determine the acute endpoint.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N-ethyl methyl allylamine

IUPAC Name:

N-ethyl methyl allylamine

Constituent 2

Reference substance name:

N-ethylmethacrylamine

EC Number:

242-217-5

EC Name:

N-ethylmethacrylamine

Cas Number:

18328-90-0

Molecular formula:

C6H13N

IUPAC Name:

N-ethyl-2-methylprop-2-en-1-amine

Test material form:

other: clear yellowish liquid

Details on test material:

- Name of test material (as cited in study report): C-1033 (N ethyl methyl allylamine)
- Physical state: clear yellowish liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data

- Storage condition of test material: 60-85°F (circa 16-30°C)
- Other: Specific Gravity stated as 0.78 g/mL

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No information
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: No information
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: animals received on 2 September 1986 and dosed on 8 October 1986

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room monitored over temperature range of circa 16-30°C
- Humidity (%): No information
- Air changes (per hr): No information
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: 8 October 1986 To: 15 October 1986

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL undiluted

Duration of treatment / exposure:

No indication of rinsing of the treated eye

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

4, two males and two females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no details
- Time after start of exposure: no data

SCORING SYSTEM: No details provided

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

probability of weak irritation

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

6

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24 h

Score:

5

Remarks on result:

positive indication of irritation

Remarks:

The cornea was completely opaque and ulcerated.

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

40

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

7 d

Score:

0

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

iris score

Basis:

animal #1

Time point:

7 d

Score:

0

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

7 d

Score:

0

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24 h

Remarks on result:

other: Unable to evaluate due to the severity of the corrosion.

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

80

Max. score:

4

Remarks on result:

positive indication of irritation

Results 13

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24 h

Remarks on result:

other: Unable to evaluate due to the severity of the corrosion.

Results 14

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24 h

Score:

80

Remarks on result:

positive indication of irritation

Results 15

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24 h

Remarks on result:

other: Unable to evaluate due to the severity of the corrosion.

Results 16

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24 h

Remarks on result:

other: Unable to evaluate due to the severity of the corrosion.

Results 17

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24 h

Score:

80

Remarks on result:

positive indication of irritation

Results 18

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24 h

Remarks on result:

other: Unable to evaluate due to the severity of the corrosion.

Results 19

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24 h

Remarks on result:

other: Unable to evaluate due to the severity of the corrosion.

Results 20

Irritation parameter:

cornea opacity score

Basis:

animal: 2, 3 and 4

Time point:

7 d

Remarks on result:

not determinable

Remarks:

Test terminated. The animals were killed for humane reasons.

Results 21

Irritation parameter:

cornea opacity score

Basis:

animal: all animals

Time point:

48 h

Remarks on result:

not measured/tested

Remarks:

Measurements not taken at this timepoint.

Results 22

Irritation parameter:

cornea opacity score

Basis:

animal: All animals

Time point:

72 h

Remarks on result:

not measured/tested

Remarks:

Measurements not taken at this timepoint.

Results 23

Irritation parameter:

iris score

Basis:

animal: All animals

Time point:

48 h

Remarks on result:

not measured/tested

Remarks:

Measurements not taken at this timepoint.

Results 24

Irritation parameter:

iris score

Basis:

animal: All animals

Time point:

72 h

Remarks on result:

not measured/tested

Remarks:

Measurements not taken at this timepoint.

Results 25

Irritation parameter:

conjunctivae score

Basis:

animal: All animals

Time point:

48 h

Remarks on result:

not measured/tested

Remarks:

Measurements not taken at this timepoint.

Results 26

Irritation parameter:

conjunctivae score

Basis:

animal: All animals

Time point:

72 h

Remarks on result:

not measured/tested

Remarks:

Measurements not taken at this timepoint.

Irritant / corrosive response data:

C-1033 was corrosive to the eye. Three of the four animals vocalized after test material administration, and at two hours exhibited corrosion of the conjunctivae (necrosis, ulceration) and the cornea was completely opaque and ulcerated.
Due to the opacity, the iris could not be evaluated. These animals were therefore killed for humane reasons. The fourth animal exhibited only slight conjunctival irritation, iritis, corneal opacity and ulceration at 24 hours. The lower outer eye lid was noted to be necrotic. Except for this necrosis and corneal stippling, this animal was free of ocular irritation by Day 7. It appears the test material did not remain in the eye long enough to produce as severe a response as noted in the other three animals.

Any other information on results incl. tables

		Pre-test Obs.		Rabbit 0876 F		Pre-test Obs.		Rabbit 0879 M
		R	L	24 h	Day 7	R	L	24 h	Day 7
Conjunc-tiva	Redness	0	0	1	0	0	0	NE	Terminated
	Chemosis	0	0	1	0	0	0	3
	Discharge	0	0	1	0	0	0	3
	Necrosis	0	0	0	0	0	0	N
	Ulceration	0	0	0	0	0	0	U
	Score	0	0	6	0	0	0	--
Iris	Iris	0	0	1	0	0	0	NE
	Score	0	0	5	0	0	0	--
Cornea	Opacity	0	0	2	0	0	0	4
	Area	0	0	4	0	0	0	4
	Stippling	0	0	0	1	0	0	0
	Ulceration	0	0	2	0	0	0	4
	Fluorescein	0	0	F	F	0	0	F
	Score	0	0	40	0	0	0	80

		Pre-test Obs.		Rabbit 0891 M		Pre-test Obs.		Rabbit 0888F
		R	L	24 h	Day 7	R	L	24 h	Day 7
Conjunc-tiva	Redness	0	0	NE	Terminated	0	0	NE	Terminated
	Chemosis	0	0	3		0	0	3
	Discharge	0	0	3		0	0	3
	Necrosis	0	0	N		0	0	N
	Ulceration	0	0	0		0	0	0
	Score	0	0	--		0	0	--
Iris	Iris	0	0	NE		0	0	NE
	Score	0	0	--		0	0	--
Cornea	Opacity	0	0	4		0	0	4
	Area	0	0	4		0	0	4
	Stippling	0	0	0		0	0	0
	Ulceration	0	0	4		0	0	4
	Fluorescein	0	0	F		0	0	F
	Score	0	0	80		0	0	80

 

NE not evaluated due to severity of response

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Necrotic lesions indicatine a corrosive effect were observed in all treated eyes.

Executive summary:

Four rabbits were treated by instillation of 0.1 mL of undiluted C-1033 (N-ethylmethylallylamine) to one eye. Lesions, including corneal opacity and conjunctival necrosis, developed in three of the eyes resulting in termination of the rabbits within two hours of dosing. The fourth eye also developed opacity and necrosis but the effects were slightly less severe. However the lesions, including an area of necrosis, persisted at day 7.