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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 August 1995 to 30 September 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The restrictions were minor deviations from the guideline.

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

(occlusive coverage (semi-occlusive recommended), humidity slightly above recommended range for a short time)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kuiper Rabbit Ranch
- Age at study initiation: 3.5 months
- Weight at study initiation: females 2.89 kg, males 2.70 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: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 33-72
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: From: 7 to 21 September 1995

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: not stated but a 147 cm2 dressing covered the site (shaved area 240 cm2, ~10% of the dorsal skin surface)
- % coverage: no data
- Type of wrap if used: 12.8 x 11.5 surgical dressing pad, covered with plastic film, then secured by lint-free cloth and an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with mineral oil
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): undiluted

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed twice daily on weekdays and once daily on weekends and holidays for mortality; observed at frequent intervals on the day of dosing and at least once daily on days 2-14 for signs of toxicity; animals were weighed immediately prior to dosing, 1 week following application of test material and at 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations following unwrapping included the examination of the application site skin for signs of dermal irritation

Statistics:

Group mean and standard deviation for body weight and body weight change

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No evidence of toxicity at >=2000 mg/kg bw

Mortality:

No deaths

Clinical signs:

other: No adverse signs were observed in any animal at any time during the study

Gross pathology:

Within normal limits

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute dermal toxicity study, which was conducted according to OECD Test Guideline 402 and in compliance with GLP, there was no evidence of toxicity following 24-hour covered contact of rabbit skin with the test material at a dose of 2000 mg/kg bw.

Executive summary:

In a GLP study, performed to OECD Test Guideline 402 (acute dermal toxicity), the test material was tested for its acute dermal toxicity in rabbits.

The test material was applied undiluted to the shaved skin of 5 male and 5 female rabbits at a dose of 2000 mg/kg bw and covered for 24 hours. The animals were observed for 14 days, weighed at the beginning and end of the study, and a gross necropsy examination was performed.

No evidence of toxicity was observed.

Under the conditions of the test, the acute dermal LD50 for the test matrial was >2000 mg/kg bw.