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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 May 1987 to 19 May 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test guideline. It was not compliant with GLP.The restrictions were that occlusive coverage was used and limited information on test material was reported (e.g. no data on purity or batch no.).

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
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:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: White Russian (albino)
Details on test animals 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(s) applied: 0.5 ml
- Concentration (if solution): 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 (female)
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:
other: mean over 24, 48 and 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:
other: mean over 24, 48 and 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:
other: mean over 24, 48 and 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:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 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:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.