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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:
5 - 19 May 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
minor deviations: coverage occlusive; limited information on test material (e.g. no data on purity or batch no.)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethoxypropylsilane
EC Number:
213-926-7
EC Name:
Trimethoxypropylsilane
Cas Number:
1067-25-0
Molecular formula:
C6H16O3Si
IUPAC Name:
trimethoxy(propyl)silane

Test animals

Species:
rabbit
Strain:
other: White Russian (albino)
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, GERMANY
- Age at study initiation: 6 months
- Weight at study initiation: 2.3-2.8 kg
- Housing: 1/cage
- Diet: standard ad libitum
- Water: drinking water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 1987-05-05 To: 1987-05-19

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
- Concentration: neat (100%)
Duration of treatment / exposure:
4 h
Observation period:
Examination 1, 24, 48, 72 h following removal of patch. Further observation up to 14 days.
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm²
- Type of wrap if used: gauze patch, synthetic foil cover, occlusive wrap

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Scaling to the end of the observation period
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Scaling to the end of the observation period
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: Scaling to the end of the observation period
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Clear defined erythema and slight edema in all three animals. Scaling to the end of the observation period (14 days).

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

1 h

1,0,0

1,0,1

24 h

2,2,2

2,2,2

48 h

2,1,2

2,2,2

72 h

2,2,1

2,2,2

Average 1h, 24h, 48h, 72h

1.42

1.67

Irritation index (1h, 24h, 48h, 72h)

3.1

Individual mean scores (24h, 48h, 72h)

2/1.67/1.67

2/2/2

Erythema or oedema were seen for up to 8 days, scaling continued to study termination at 14 days. (Limited information appear to be presented on observations post-72h.)

No systemic toxicity was reported.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are met, Category 2 (irritant) classification required according to Regulations (EC) No. 1272/2008
Conclusions:
In a skin irritation study conducted largely in accordance with OECD 404, but without GLP status (reliability score 2), trimethoxy(propyl)silane was irritating to the skin of rabbits.