4-(1-oxo-2-propenyl)-morpholine

Endpoint summary

Description of key information

Skin:
The substance is considered to be mildly irritating to rabbit skin.

Eye:
Instillation of the substance into rabbit eye elicited positive response in all 9 treated animals. Irrigation of the eyes, 4 or 30 seconds after instillation did not reduce the irritant potential of the substance.

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

Study period:

From 29 October to 01 November 2985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

this study was performed before the amendment of Annex VII and VIII

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

no reading at 48 hours

GLP compliance:

not specified

Specific details on test material used for the study:

Lot No.: 6032505
Purity: not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield rabbits, Petersfield, England.
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 2.2-3.1 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hour period

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 2.5 cm square gauze pad to one intact and one abraded skin site on each animal.
- Type of wrap if used: "Elastoplast" elastic adhesive dressing backed with "Sleek" plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): occlusive dressing and gauze pads removed and treatment sites wiped to remove residual test substance.
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 24 and 72 hours after application of test substance

SCORING SYSTEM:
- Method of calculation: Draize

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/72 hours

Score:

0.45

Max. score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

probability of mild irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24/72 hours

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slight erythema was observed in six intact and five abraded sites at the 24 hours reading.
These reactions had resolved completely by the 72 hours reading.

Dermal reactions:

Rabbit number	E=Erythema O=Oedema	24 hours		72 hours
		Intact	Abraded	Intact	Abraded
703	E O	1 0	1 0	0 0	0 0
825	E O	1 0	1 0	0 0	0 0
833	E O	1 0	0 0	0 0	0 0
841	E O	1 0	1 0	0 0	0 0
868	E O	1 0	1 0	0 0	0 0
870	E O	1 0	1 0	0 0	0 0

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is considered to be mildly irritating to rabbit skin.

Executive summary:

The study is performed to assess skin irritation potential of the substance to rabbit, according to test method similar with OECD Guideline 404 with some deviations.

The substance is considered to be mildly irritating to rabbit skin.

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

Study period:

From 21 April to 02 June 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Specific details on test material used for the study:

Lot No.: 6032505
Purity: not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Buckmasters, Henham and Interfauna Ltd., England
- Age at study initiation: 11-14 weeks
- Weight at study initiation: 2.4-3.2 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30-70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hour period

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

4 or 30 seconds

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

3 for no rinse; 3 for rinse after 4 seconds; 3 for rinse after 30 seconds

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed gently with water for 5 minutes
- Time after start of exposure: 4 or 30 seconds

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: handheld torch

Observations time: after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after instillation.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1.44

Max. score:

3

Reversibility:

not fully reversible within: 21 d

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 7 d

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 14 d

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

Eyes no rinse:
All three animals gave positive response.
Corneal opacities developed in all 3 animals. Vascularization was seen in one animal.
Iridial inflammation was observed in two animals.
A diffuse crimson red colouration of the conjunctivae was seen in two animals. Considerable swelling with partial eversion of the eyelids was seen in one animal. The eyes of two animals were normal seven days after instillation.

Eyes rinsed after 4 seconds:
All three animals gave positive response.
Corneal opacities developed in all 3 animals. Vascularization was seen in two animals.
Iridial inflammation was observed in two animals.
A diffuse crimson red colouration of the conjunctivae was seen in two animals accompanied by considerable swelling with partial eversion of the eyelids. The eyes were normal seven or 14 days after instillation.

Eyes rinsed after 30 seconds:
All three animals gave positive response.
Corneal opacities developed in all 3 animals. Iridial inflammation was observed in two animals.
A diffuse crimson red colouration of the conjunctivae was seen in all 3 animals accompanied by considerable swelling with partial eversion of the eyelids. The eyes were normal seven days after instillation.

Scores for eyes not rinsed:

Rabbit number	Eye region	Time
		24 h	48 h	72 h
1830	Cornea	1	3	3
	Iris	1	1	1
	Conjunctivae redness	1	2	2
	Chemosis	2	1	2
1834	Cornea	2	2	0
	Iris	0	0	0
	Conjunctivae redness	1	1	1
	Chemosis	1	0	0
3062	Cornea	1	1	0
	Iris	0	0	0
	Conjunctivae redness	1	2	2
	Chemosis	1	1	1

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Instillation of the substance into rabbit eye elicited positive response in all 9 treated animals. Irrigation of the eyes, 4 or 30 seconds after instillation did not reduce the irritant potential of the substance.

Executive summary:

The study is performed to assess eye irritation potential of the substance to rabbit, according to OECD Guideline 405.

Instillation of the substance into rabbit eye elicited positive response in all 9 treated animals. Irrigation of the eyes, 4 or 30 seconds after instillation did not reduce the irritant potential of the substance.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin irritation / corrosion:
In vivo skin irritation, key study, OECD 404:
Mean score for erythema at 24, 72 h for 6 animals: 0.45
Mean score for edema at 24, 72 h for 6 animals: 0
According to Regulation (EC) No 1272/2008, table 3.2.2, this substance should not be classified for this endpoint.

Eye irritation:
In vivo eye irritation, key study, OECD 405:
Mean scores for cornea opacity, iris, conjunctivae and chemosis at 24, 48, and 72h: 1.44, 0.33, 1.33, 1. And the severe effects were not fully reversed within 21 days.
Therefore, according to Regulation (EC) No 1272/2008, table 3.3.1, this substance should be classified as Cat 1 Irreversible effects on the eye.