N-ethylmethacrylamine

Endpoint summary

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:

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.

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Principles of method if other than guideline:

Four rabbits exposed to 0.5 mL of undiluted test substance and assessment of dermal response at 72 hours after application

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Details on test animals or test system 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 16 or 23 September or 9 December 1986 and dosed on 9 or 16 October or 31 December respectively

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: 9 October 1986 To: 7 January 1987

Type of coverage:

not specified

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL of undiluted test substance

Duration of treatment / exposure:

No data

Observation period:

Results presented for the 72 hour post-application observation point

Number of animals:

Four

Details on study design:

Four rabbits dosed with 0.5 ml of undiluted test material and observed subsequently for a dermal response based on elicitation of erythema and/or oedema

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

probability of severe irritation

Irritation parameter:

edema score

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #4

Time point:

72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks on result:

no indication of irritation

Irritation parameter:

other: Evidence of severe tissue damage at each of the treated sites

Basis:

other: reaction observed at each of four treated sites

Time point:

72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: necrosis and eschar observed at each abraded site

Irritant / corrosive response data:

All four rabbits showed evidence of severe tissue damage with grade 4 erythema, necrosis and eschar apparent with oedema also present for one rabbit. The reactions were indicative of a corrosive response.

Interpretation of results:

Category 1 (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Evidence of corrosivity was observed under the conditions of this study.

Executive summary:

Four rabbits were treated by application of 0.5 ml of undiluted C-1033 (N-ethylmethylallylamine) to abraded dermal sites. Dermal reactions were assessed after 72 hours. All four rabbits showed evidence of severe tissue damage with grade 4 erythema, necrosis and eschar apparent with oedema also present for one rabbit; evidence of corrosivity was observed under the conditions of this study.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

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.

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

GLP compliance:

not specified

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

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

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

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

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

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

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

6

Remarks on result:

positive indication of irritation

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.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24 h

Score:

40

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

7 d

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

7 d

Score:

0

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

7 d

Score:

0

Remarks on result:

no indication of irritation

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.

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

80

Max. score:

4

Remarks on result:

positive indication of irritation

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.

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24 h

Score:

80

Remarks on result:

positive indication of irritation

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.

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.

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24 h

Score:

80

Remarks on result:

positive indication of irritation

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.

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.

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.

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.

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.

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.

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.

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.

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.

		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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In a study of dermal irritation / corrosion, four rabbits were treated by application of 0.5 ml of undiluted N-ethylmethylallylamine to abraded dermal sites. Dermal reactions were assessed after 72 hours. All four rabbits showed evidence of severe tissue damage with grade 4 erythema, necrosis and eschar apparent with oedema also present for one rabbit; evidence of corrosivity was observed under the conditions of this study.

In a study of eye irritation, four rabbits were treated by instillation of 0.1 mL of undiluted 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.

Justification for selection of skin irritation / corrosion endpoint:

Only one study available for this endpoint

Justification for selection of eye irritation endpoint:

Available data sourced from one study summary submitted in accordance with TSCA Section 8 (e) Compliance Audit Programme criteria

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the results of the available studies, N- ethylmethyl allylamine requires classification as Corrosive in Category 1 H314: Causes severe skin burns and eye damage in accordance with Regulation (EC) No. 1272/2008 (CLP Regulation).