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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:
16 Sep 1991 - 17 Feb 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: New Zealand hybrid albino
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bancel, St Rambert D'Albon, FRANCE
- Age at study initiation: "adult"
- Weight at study initiation: 2.5±0.2 kg
- Housing: 1/cage; polystyrene cage with perforated flooring
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): no details given
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no details given

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: 0.5 ml
- Concentration: neat
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, 72 h. No further observation required.
Number of animals:
Six males
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage: not stated
- Type of wrap if used: 8 layer gauze pad, covered with perforated tape on crimped gauze bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): protocol states that excess test material should be wiped away with gauze moistened with distilled water if necessary. It is not clear if this was the case.
- Time after start of exposure: 4 h

SCORING SYSTEM: according to Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
See Table 1.
Other effects:
None reported.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

60 min

1/0/1/1/1/1

0/0/0/0/0/0

24 h

0/0/0/1/1/0

0/0/0/0/0/0

48 h

0/0/0/0/0/0

0/0/0/0/0/0

72 h

0/0/0/0/0/0

0/0/0/0/0/0

Average 24h, 48h, 72h

0.1

0

Reversibility*

c

-

time for reversion

48 h

-

* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
A skin irritation study conducted in accordance with OECD 404 and GLP (reliability score 1), found triethoxy(methyl)silane to be transiently irritating to the skin of rabbits. The report describes the material as non irritant according to EC criteria; current EC criteria would concur with this finding.