1,2-Ethanediamine, N1-(2-aminoethyl)-, 2-hydroxy-2-phenylethyl and stearyl derivs.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 August 1989 to 5 September 1989.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-({2-[(2-hydroxy-2-phenylethyl)({2-[(2-hydroxy-2-phenylethyl)amino]ethyl})amino]ethyl}(octadecyl)amino)-1-phenylethan-1-ol; 2-({2-[(2-hydroxy-2-phenylethyl)[2-(octadecylamino)ethyl]amino]ethyl}(octadecyl)amino)-1-phenylethan-1-ol; 2-({2-[(2-hydroxy-2-phenylethyl)amino]ethyl}[2-(octadecylamino)ethyl]amino)-1-phenylethan-1-ol; 2-{[2-({2-[bis(2-hydroxy-2-phenylethyl)amino]ethyl}(2-hydroxy-2-phenylethyl)amino)ethyl](octadecyl)amino}-1-phenylethan-1-ol

EC Number:

807-655-9

Cas Number:

1629160-48-0

Molecular formula:

Not available - UVCB substance

IUPAC Name:

2-({2-[(2-hydroxy-2-phenylethyl)({2-[(2-hydroxy-2-phenylethyl)amino]ethyl})amino]ethyl}(octadecyl)amino)-1-phenylethan-1-ol; 2-({2-[(2-hydroxy-2-phenylethyl)[2-(octadecylamino)ethyl]amino]ethyl}(octadecyl)amino)-1-phenylethan-1-ol; 2-({2-[(2-hydroxy-2-phenylethyl)amino]ethyl}[2-(octadecylamino)ethyl]amino)-1-phenylethan-1-ol; 2-{[2-({2-[bis(2-hydroxy-2-phenylethyl)amino]ethyl}(2-hydroxy-2-phenylethyl)amino)ethyl](octadecyl)amino}-1-phenylethan-1-ol

Test material form:

other: solid, moltem mass

Details on test material:

- Test article: FAT 92267/A
- Batch N°: EN 3.86
- Content of active ingredients: 81.1%
- Physical properties: Solid, molten mass
- Storage conditions: Room temperature
- Safety precautions: Gloves and face masks
- Test material received: August 18, 1989.

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: EN 3.86

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Approx. 12-14 weeks old
- Weight at study initiation: 2240 g to 2990 g
- Housing: The animals were housed individually in metal cages, identified by ear tattoo
- Diet: The rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: Ad libitum
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: A control gauze patch moistened with distilled water was applied to the contralateral flanl.

Amount / concentration applied:

0.5 ml of the test article was applied to the right flank of each animal.

Duration of treatment / exposure:

4 h

Observation period:

The skin reactions were evaluated 1, 24, 48 and 72 h afetr removing the gauze patches.

Number of animals:

3 female rabbits

Details on study design:

An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 ml of the test article was applied to the right flank of each animal. A control gauze patch moistened with distilled water was applied to the contralateral flank. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

SCORING SYSTEM:
Erythema and eschar formation.
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well defined erythema: 2
- Moderate to severe erythema: 3
- Severe erythema (beet redness) to slight eschar formation ( inj uries in depth): 4
Total possible erythema score 4

Edema formation
- No edema: 0
- Very slight edema (barely perceptible): 1
- Slight edema (edges of area well defined by definite raising): 2
- Moderate edema (raised approximately 1 nun): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

3 animal

Time point:

24/48/72 h

Score:

0.44

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

Erythema and edema was seen.

Other effects:

All animals showed expected gain in body weight during the study.

Any other information on results incl. tables

 

	Individual skin reaction score
Time after exposure hours	Erythema						Edema
	Animal 1		Animal 1		Animal 3		Animal 1		Animal 1		Animal 3
	Control flank	Test flank	Control flank	Test flank	Control flank	Test flank	Control flank	Test flank	Control flank	Test flank	Control flank	Test flank
24	0	2	0	1	0	1	0	1	0	1	0	1
48	0	2	0	0	0	1	0	1	0	0	0	0
72	0	1	0	0	0	1	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions employed, FAT 92267/A is non-irritant to the skin rabbit.

Executive summary:

The study was performed to assess the irritancy potential of FAT 92267/A to the skin of the New Zealand White rabbit according to the OECD Guideline 404. An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 ml of the test article was applied to the right flank of each animal. A control gauze patch moistened with distilled water was applied to the contralateral flank. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape. There were no effects on body weight gain. All animals showed erythema and edema during initial days of observation period. Because reactions were observed within 72 h after removing the bandages, the observation period was extended to 7 days to determine the reversibility of the skin reactions. According to the EEC classification of the results obtained 24 to 72 h after removing the bandages FAT 92267/A can be classified as non-irritant in rabbits. The skin reactions observed were reversible until the end of the observation period on day 7. So, under the experimental conditions employed, FAT 92267/A is non-irritant to the skin in rabbits.