Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 January 1987 to 19 January 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were: occlusive application used, maximum temperature may have been very slightly higher than recommended. It was not compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive application (semi-occlusive recommended), temperature of 22 ± 2 °C (20 ± 3 °C recommended)
Qualifier:
according to
Guideline:
other: 84/449/EEC
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DEGUSSA-Silane Si 264 (3-Thiocyanatopropyltriethoxysilan)
- Substance type: no data
- Physical state: colourless liquid
- Analytical purity: no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: Wi 12083 (dest.)
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other: Solubility: hardly soluble in water

Test animals

Species:
rabbit
Strain:
other: White Russian (Albino)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: ASTA-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 5 to 8 months
- Weight at study initiation: 2.20 to 2.45 kg
- Housing: singly in stainless tell cages type ASTA
- Diet (e.g. ad libitum): standard diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 13 January 1987 To: 30 January 1987

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: one test patch and one untreated control patch was applied to the dorsal area of each animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
~6 days (observation times: 1, 24, 48 and 72 hours after patch removal, and 6 days after application)
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm2
- % coverage: no data
- Type of wrap if used: linen cloth secured by synthetic film glue, with an occlusive bandage wrapped around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data

SCORING SYSTEM: Draize method (see "Any other information on materials and methods incl. tables")

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 6 days of application
Remarks on result:
other: individual scores 1,1,0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 6 days of application
Remarks on result:
other: individual scores 1,2,1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days of applcation
Remarks on result:
other: individual scores 1,1,1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: all
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days of application
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour, 48 hours and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: individual scores 0,0,0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours of patch removal
Remarks on result:
other: individual scores 0,1,0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: all
Score:
0.08
Max. score:
4
Reversibility:
fully reversible within: 48 h of patch removal
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
sum of mean erythema and oedema scores
Time point:
other: all
Score:
1.1
Max. score:
8
Reversibility:
fully reversible within: 6 days of application
Irritant / corrosive response data:
Two animals displayed erythema immediately after patch removal. Ond developed erythema 24 hours after patch removal. In all cases, erythema was grade one, except at 24 hours in one of the animals displaying an immediate reaction, when grade 2 erythema was observed. In each case, erythema was still visible at 72 hours, but not at five days after patch removal.

Grade 1 oedema was seen in one animal 24 hours after patch removal. This was no longer visible 48 hours after patch removal.
Other effects:
There was no evidence of systemic toxicity or mortality throughout the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a study carried out according to OECD Test Guideline 404, Si 264 (triethoxy(3-cyanatopropyl)silane) was slightly irritating (by Draize criteria) to the skin of rabbits when applied under occlusion for 4 hours, with an overall irritation index of 1.1.
Executive summary:

In a study carried out according to OECD Test Guideline 404, Si 264 (triethoxy(3-cyanatopropyl)silane) was tested for its skin irritation potential in rabbits.

 

0.5 ml of undiluted Si 264 was applied under occlusion to the shaved skin of three male rabbits for 4 hours. Patches not containing the test substance were also applied to the skin of the same three males to act as concurrent control regions. Rabbits were then observed at 1, 24, 48 and 72 hours after patch removal, and 6 days after application. Skin reactions were graded according to the Draize system.

 

Very slight erythema was observed in all test animals, starting within 24 hours of patch removal (in two animals, an immediate reaction was observed). In one rabbit, erythema became well-defined at 24 hours, and was accompanied by very slight oedema. Oedema was not seen in any other animal, or at any other time point. All signs of irritation were fully reversible within 6 days of application. There were no signs of systemic toxicity, or mortality throughout the study.

 

Si 264 was judged to be slightly irritating according to Draize criteria (i.e. an irritation index between 0.6 and 3.0), based on an irritation index of approximately 1.1, calculated from the sum of mean scores for erythema (1.0) and oedema (0.8). On the basis of this test it would not classified as irritating by EU criteria.