Reaction mass of 1,1,1,5,5,5-hexamethyl-3-phenyl-3-((trimethylsilyl)oxy)trisiloxane and 1,1,1,7,7,7-hexamethyl-3,5-diphenyl-3,5-bis[(trimethylsilyl)oxy]tetrasiloxane and 1,1,1,9,9,9-hexamethyl-3,5,7-triphenyl-3,5,7-tris((trimethylsilyl)oxy)pentasiloxane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 August 1995 to 30 September 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kuiper Rabbit Ranch, Gary, IN
- Age at study initiation: 2.5 months
- Weight at study initiation: 1.74-2.23 kg
- Housing: stainless steel cages with mesh floors, 61.0 x 45.5 x 41.0 cm
- Diet (e.g. ad libitum): 150 g/day, Purina Lab Rabbit Chow HF #5326
- Water (e.g. ad libitum): ad libitum, reverse osmosis-purified water
- Acclimation period: 9 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-34
- Humidity (%): 41-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: From: 29 August 1995 to 1 September 1995

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: not stated, but test site covered with 6.25 cm2 patch (shaved area was 240 cm2)
- % coverage: no data
- Type of wrap if used: 2.5 x 2.5 cm 12-ply cotton gauze patch secured with porous tape; mid-section of each rabbit wrapped in lint-free cloth secured by an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done (no residual test material visible) - area wiped with gauze
- Time after start of exposure: 4 hours

SCORING SYSTEM: Primary Dermal Irritation Score:
Erythema and eschar formation:
no erythema 0
very slight erythema 1
well-defined erythema 2
moderate-severe erythema 3
severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation:
no oedema 0
very slight oedema 1
slight oedema 2
moderate oedema 3
severe oedema 4

Descriptive rating:
0 non-irritating (grade 0)
0.1-1.5 minimally irritating (grade 1)
1.6-3.0 mildly irritating (grade 2)
3.1-5.0 moderately irritating (grade 3)
5.1-8.0 severely irritating (grade 4)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 30-60min, 24 h, 48 h, 72 h

Score:

0

Max. score:

8

Remarks on result:

other: All animals, all endpoints, all timepoints - score 0

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Non-irritant - see table 1

Other effects:

No deaths

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

One male and 2 female rabbits:

Score at time point / Reversibility	Erythema	Edema
	Max. score: 0	Max. score: 0
30-60 min	0/0/0	0/0/0
24 h	0/0/0	0/0/0
48 h	0/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0	0/0/0

 

Erythema: 0=none, 1=very slight, 2=well defined, 3=moderate to severe 4=severe erythema to slight eschar formation

Edema; 0=none, 1=very slight, 2=slight, 3=moderate, 4 =severe 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the skin irritation study, which was conducted according to OECD Test Guideline 404 and in compliance with GLP, the undiluted test material was not irritating to the skin of rabbits, following 4 hours semi-occlusive contact.

Executive summary:

In a study performed according to OECD Test Guideline 404 (Acute dermal irritancy/corrosivity) and in compliance with GLP, the test material was tested for its potential to induce skin irritation in rabbits.

A 0.5 ml volume of the test material was applied undiluted for 4 hours to the shaved backs of three (two male and one female) New Zealand White rabbits, semi-occluded. All test sites were examined for signs of dermal irritation (i.e. oedema, erythema and/or eschar formation) and corrosivity (i.e. ulceration and/or necrosis) 30-60 minutes and 24, 48 and 72 hours following removal of the patch. The primary Dermal Irritation Index (PDII) was calculated according to Draize criteria.

 

No signs of dermal irritation or corrosivity were observed in the three rabbits at any timepoint. The PDII for the test material was 0.

Under the conditions of the test, the test material was not irritating to rabbit skin.