Registration Dossier

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:
1988-08-05 to 1990-04-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose:
read-across source

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)
Principles of method if other than guideline:
6 animals used.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, France
- Age at study initiation: adult
- Weight at study initiation: 2.40 - 2.65 kg
- Housing: individually hosted in polystyrene cages
- Diet: 150 g per rabbit per day of complete pelleted rabbit maintenance diet
- Water: softened and filtered mains drinking water, ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 -23
- Humidity (%): 36 - 75 % R.H.
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml


Duration of treatment / exposure:
3 minutes (group 1) or 4 hours (group 2)
Observation period:
14 days (at 1h, 24h, 48h and 72h)
Number of animals:
6 males per group (2 groups)
Details on study design:
TEST SITE
- Area of exposure: back and flank
- % coverage: no data
- Type of wrap if used: semi-occlusive dressing (perforated adhesive tape, applied on a band of gauze)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 3 minutes or 4 hours

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:
not reversible
Remarks:
whole application area 'burned' by day 7 of observation. Desquamation by day 14.
Remarks on result:
other: corrosion
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Remarks:
Whole application area 'burned' by day 7 of observation. Desquamation by day 14.
Remarks on result:
other: corrosion
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
whole application area 'burned' by day 7 of observation.
Remarks on result:
other: corrosive
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not reversible
Remarks:
whole application area 'burned' by day 7 of observation. Desquamation by day 14.
Remarks on result:
other: corrosive
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
not reversible
Remarks:
whole application area 'burned' by day 7 of observation. Desquamation by day 14.
Remarks on result:
other: corrosive
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.7
Max. score:
4
Reversibility:
not reversible
Remarks:
whole application area 'burned' by day 7 of observation. Desquamation by day 14.
Remarks on result:
other: corrosive
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The erythema observations of group 1 (3 minutes application) showed that less than a quarter or half of the treated area, in all the individuals, was burnt. Dryness of the treated area could be also observed 72 hours post-treatment. Very slight edema was noted in 4 individuals, within the observation period.

The erythema observations of group 2 (4 hours application) showed that the treated area was necrotic and dry throughout the whole observation period. Slight to moderate edema was reported in most of the individuals within 72 hours post-exposure.
Other effects:
The severe lesions in group 1 (3 minutes application) at 72-hour observation, were reported to be noticeably reversible within 14 days post-application. However, when the test substance was applied for 4 hours to the area in group 2, no reversibility could be observed.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
The skin irritation study, conducted according to OECD TG 404 and in compliance with GLP, reports that the substance, 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine, is corrosive.