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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 August 1990 to 10 August 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: The test item was applied undiluted.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was applied undiluted.
- Preliminary purification step (if any): none
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazelton, Kalamazoo, Michigan
- Age at study initiation: young, no further information given
- Weight at study initiation: 2.27 - 2.33 kg
- Housing: All rabbits were housed individually in clean, stainless steel cages
- Diet (e.g. ad libitum): Purina Lab Rabbit Chow, ad libitum
- Water (e.g. ad libitum): fresh water, as libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled, but range not specified
- Humidity (%): controlled, but range not specified
- Air changes (per hr): controlled, but range not specified
- Photoperiod (hrs dark / hrs light): controlled, but range not specified

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): not applicable

VEHICLE: Not used
NEGATIVE CONTROL: Not used
POSITIVE CONTROL: Not used
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: dorsal area
- % coverage: approximately 6 cm², percentage not specified
- Type of wrap if used: porous gauze dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with tap water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
at 1, 24, 48 and 72 hours

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
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
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
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
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
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
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
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
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No effects on body weight gain, food consumption or behaviour were observed in any of the test animals. No skin irritation was observed in any of the test animals.
Other effects:
- Other adverse local effects: no effects
- Other adverse systemic effects: no effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the skin irritation study, conducted according to an appropriate OECD 404 Test Guideline and in compliance with GLP, the test material Reaction Mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers was reported to be not irritating to skin.