Tris[2-[[2,4,8,10-tetra-tert-butyldibenzo[d,f][1,3,2]dioxaphosphepin-6-yl]oxy]ethyl]amine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Aug - Sep 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified with the help of a "Schröpfschnäpper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm with 0.5 g of the test material were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour application. The skin reaction was appraised upon removal and during an observation period of 7 days.

GLP compliance:

no

Remarks:

pre-GLP study

Test material

Test material information

Constituent 1

Reference substance name:

Tris[2-[[2,4,8,10-tetra-tert-butyldibenzo[d,f][1,3,2]dioxaphosphepin-6-yl]oxy]ethyl]amine

EC Number:

279-459-6

EC Name:

Tris[2-[[2,4,8,10-tetra-tert-butyldibenzo[d,f][1,3,2]dioxaphosphepin-6-yl]oxy]ethyl]amine

Cas Number:

80410-33-9

Molecular formula:

C90H132NO9P3

IUPAC Name:

2-[(2,4,8,10-tetra-tert-butyldibenzo[d,f][1,3,2]dioxaphosphepin-6-yl)oxy]-N,N-bis{2-[(2,4,8,10-tetra-tert-butyldibenzo[d,f][1,3,2]dioxaphosphepin-6-yl)oxy]ethyl}ethanamine

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited
- Weight at study initiation: 2 - 3 kg
- Housing: individually
- Diet: standard rabbit food (NAFAG, No. 814, Gossau SG); ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: polyethylene glycol (PEG 400) + saline (70:30 parts)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50%

VEHICLE
- Concentration (if solution): polyethylene glycol (PEG 400) + saline (70:30 parts)

Duration of treatment / exposure:

24 h

Observation period:

7 days

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: gauze patches, covered with an impermeable material

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
upon removal and during an observation period of 7 days

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 (injuries 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 mm).................................3
Severe edema (raised more than 1 mm and extending beyond area of exposure).............4
Total possible edema score 4

Assessment of irritation:
0
0.1-1.0 = minimal
1.1-2.0 = slight
2.1-4.0 = moderate
4.1-6.0 = marked
6.1-8.0 = extreme

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Remarks:

intact skin

Basis:

mean

Time point:

other: 24/72 h

Score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test substance was found to cause a minimal irritation when applied to abraded rabbit skin.
There were no irritating effects when the test substance was applied to intact skin.

Other effects:

No signs of systemic intoxication were observed throughout the whole test period.

Any other information on results incl. tables

Table 1: Calculation of the primary skin irritation index

	MEAN REACTION SCORE
Time after exposure hours	eryth e ma				edema
	intact skin	abraded skin			intact skin		abraded skin
24	0	0.3			0		0
72	0	0.2			0		0
total	0	+	0.5	+0		+		0	=	0.5

primary irritation index = 0.5 : 4 = 0.1

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present experiment the test substance was found to cause a minimal irritation when applied to abraded rabbit skin.
The calculated primary irritation index was 0.1.
There were no irritating effects when the test substance was applied to intact skin.