Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1997/12/01-1997/12/05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: White New Zealand albino, HsdPoc:NZW
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Harlan, Winkelmann GmbH, 33176 Borchen, Gartenstrasse 27

- Age at study initiation: young adults

- Weight at study initiation: 2.6-3 kg

- Housing: Conventional, single housing in stainless steel cages

- Diet: Ssniff K 4 complete feed for rabbits, ad libitum. Supplied by Ssniff, Spezialfutter GmbH, 59494 Soest

- Water: Tap water, ad libitum

- Acclimation period: minimum of 14 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20 +/- 3

- Humidity (%): 30-70

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped, intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5 cm3

- Concentration (if solution):undiluted

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3M
Details on study design:
TEST SITE

- Area of exposure: not specified

- coverage: 6 cm2

- Type of wrap if used: the area of exposure was covered with gauze patch which was secured in place with a non irritant plaster. The patch was held in contact with the skin by a suitable semi-occlusive dressing.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): with warm water

- Time after start of exposure:4 hours


SCORING SYSTEM: According to OECD

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
The exposure to test substance caused no skin reaction in 2 animals 30-60 min after removal of the dressing. One animal showed very slight erythema and oedema after 1 hour. 24 to 72 hours after patch removal no skin reaction was observed in all animals.
Other effects:
None reported.

Any other information on results incl. tables

All scores were zero at all time points after patch removal, except for in one animal in which the score was 1 at 1 hour for erythema and eschar and oedema formation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a reliable study conducted according to an appropriate test protocol, and in compliance with GLP, tetramethylsilane was found to be non-irritant to rabbit skin.