(R)-(-)-1-methoxy-2-propylamine

Skin irritation / corrosion

Administrative data

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: Dermal irritation was evaluated in a acute dermal study (24 hours treatment, occlusive coverage of test sites)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Principles of method if other than guideline:

Dermal irritation was evaluated in an acute dermal toxicity study performed according to EPA OPPTS 870.1200 (Acute Dermal Toxicity)

GLP compliance:

yes

Remarks:

United States Environmental Protection Agency TSCA: Good Laboratory Practice Standards, 40 CFR 792

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): s-MOIPA
- Physical state: clear, light-yellow liquid
- Purity test date: 94.1 - 95.3%
- Lot/batch No.: 7/11/97
- Storage condition of test material: the test material was stored at room temperature.

Test animals

Species:

rabbit

Strain:

other: Hra:(NZW)SPF

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the amount of test material applied to the test site in a thin and uniform layer was approximately 0.006 g/cm2 (500 mg/kg dose level) to 0.04 g/cm2 (3000 mg/kg dose level).

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

5 males and 5 females (except the 3000 mg/kg dose group, where the treatment was interrupted for humane reasons, after 3 males were treated)

Details on study design:

TEST SITE
- Area of exposure: 180 cm2
- % coverage: occlusive
- Type of wrap if used: the area of application was covered with a zl-ply 9.5-cm x 19-cm gauze pateh secured with paper tape and overwrapped with Saran Wrap<0 and Elastoplast® tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after the 24-hour exposure period

SCORING SYSTEM: similar to the OECD scoring system (at least for erythema and edema; see below)
- Erythema: 0, No erythema; 1, Very slight erythema (barely perceptible); 2, Well-defined erythema; 3, Moderate to severe erythema; 4, Severe erythema (beet redness) to slight eschar formation (injuries in depth).
- Edema: 0, No edema; 1, Very slight edema (barely perceptible); 2, Slight edema (edges are well defined by definite raising); 3, Moderate edema (raised approximately 1 mm); 4, Severe edema (raised approximately 1 mm and extending beyond area of exposure).
- Atonia: 0, None; 1, Slight (slight impairment of elasticity); 2, Moderate (slow return to normal); 3, Marked (no elasticity);
- Desquamation: 0, None; 1, Slight; 2, Moderate (scales and flakes); 3, Marked (pronounced flaking with denuded areas).
- Coriaceousness: 0, None; 1, Slight (decrease in pliability); 2, Moderate (leathery texture); 3, Marked (tough and brittle).
- Fissuring: 0, None; 1, Slight (definite cracks in epidermis); 2, Moderate (cracks in dermis); 3, Marked (cracks with bleeding)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72- hour

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: Erythema scores in the 500 and 1000 mg/kg bw dose levels remain at 4 at the end of the observation period with echar formation and possible necrotic areas

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1-14 days

Max. score:

4

Remarks on result:

other: see table 1

Irritant / corrosive response data:

Based to the gravity of the erythema scores, as well as crusted areas, eschar, discoloration of the underlying muscle and necrosis, and although the treatment period was 24 hours instead of 4 hours and the coverage of test sites occlusive instead of semi-occlusive, the test substance should be considered corrosive to the rabbit skin (worst case consideration giving the 24 hours treatment and the occlusive coverage of test sites; R34 according to the EU and Category 1C according to GHS).

Other effects:

All animals showed eschar formation (generally from day 3 to the end) or possible necrotic areas (generally at day 1). At necropsy, the treated skin of each animal was observed to be variable dark-brown or red, with or without crusted areas. The treated skin was also thickened in some animals. The underlying muscle in some animals was also dark-brown or tan. These findings are attributed to the irritation/injury caused by the test material.

Any other information on results incl. tables

Table 1: Individual dermal irritation observation

 

Test group	Sex	Observation	Scores
			Mean 1-3 days	Day 14
500 mg/kg bw	First male	Erythema	4	4
		Edema	2	1
	Second male	Erythema	4	4
		Edema	1.5	1
	Third male	Erythema	4	4
		Edema	1.5	1
	Fourth male	Erythema	4	4
		Edema	1.5	1
	Fifth male	Erythema	4	1.5
		Edema	1.5	1
	First female	Erythema	4	4
		Edema	3	1
	Second female	Erythema	4	4
		Edema	1.5	1
	Third female	Erythema	4	4
		Edema	1.5	1
	Fourth female	Erythema	4	4
		Edema	2	1
	Fifth female	Erythema	4	1.5
		Edema	2.5	1
1000 mg/kg bw	First male	Erythema	4	4
		Edema	1.5	1
	Second male	Erythema	4	4
		Edema	2	1
	Third male	Erythema	4	4
		Edema	1.5	1
	Fourth male	Erythema	4	4
		Edema	1.5	1
	Fifth male	Erythema	-	-
		Edema	-	-
	First female	Erythema	4	4
		Edema	1.5	1
	Second female	Erythema	4	4
		Edema	1.5	1
	Third female	Erythema	4	4
		Edema	1.5	1
	Fourth female	Erythema	4	4
		Edema	1.5	1
	Fifth female	Erythema	4	1.5
		Edema	2	1