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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:
120 hours
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Triethoxy(2,4,4-trimethylpentyl)silane
EC Number:
252-558-1
EC Name:
Triethoxy(2,4,4-trimethylpentyl)silane
Cas Number:
35435-21-3
Molecular formula:
C14H32O3Si
IUPAC Name:
triethoxy(2,4,4-trimethylpentyl)silane
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing:ABS - plastic cages, floor 4200 cm2
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Described as 'adequate'.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18± 3
- Humidity (%): 55± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

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


Duration of treatment / exposure:
Four hours.
Observation period:
120 hours
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: Not stated
- Type of wrap if used: gauze patch held in place with non-irritating tape and semi-occlusive dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with water.
- Time after start of exposure: Four hours.


SCORING SYSTEM: As per OECD 404.

Individual reactions of each animal were recorded at each observation time (1, 24, 48, 72, 96 and 120 hours). Nature, severity and duration of all lesions observed were described. Body weight were recorded at the start of the study and 72 hours after patch removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 96 hours
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
fully reversible within: 120 hours
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak 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
Irritant / corrosive response data:
Very slight to moderate irritant effects (erythema) in all three animals on the intact skin 24 hours after patch removal. Very slight to well-defined skin reactions (erythema) in two animals at 48 and 72 hours. At the 96 hour reading a very slight erythema was still found in one animal. By 120 hours there were no signs of irritation.
Other effects:
There were no significant body weight changes at any point in the study. There were no other signs of toxicity.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In the in vivo skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, triethoxy(2,4,4-trimethylpentyl)silane was concluded to be not irritating to rabbit skin.