Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6 and 19 July 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
EC Number:
221-336-6
EC Name:
N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine
Cas Number:
3069-29-2
Molecular formula:
C8H22N2O2Si
IUPAC Name:
N-[3-[dimethoxy(methyl)silyl]propyl]ethane-1,2-diamine

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan UK, England
- Age at study initiation: minimum of 11 weeks
- Weight at study initiation: 2.3-2.7kg
- Housing: individually housed in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 13-27.5
- Humidity (%): 38-68
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
4 hours
Observation period:
Examination of the treated skin was made at 1, 24, 48, 72 hours after exposure. Additional observations were made for all animals on days 5 through 10 and two animals on days 11 through 14.
Number of animals:
1 male, 2 females
Details on study design:
TEST SITE
- Area of exposure: dorso-lumbar region
- Type of wrap if used: gauze pad, and elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm water
- Time after start of exposure: 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:
3
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritant / corrosive response data:
Well-defined to moderate to severe erythema with slight oedema was observed in all three animals. In addition, desquamation of the corneum stratum (characterised by dryness and sloughing) was seen in three animals, thickening of the skin in two animals and cracking of the skin in one animal. Reactions gradually ameliorated and had resolved completely in one animal by day 10, however, very slight to well-defined erythema was still present in the remaining two animals at study termination on day 14.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In a reliable study conducted according to OECD Test Guideline 404 and in compliance with GLP, the test material is concluded to be a Category 2 skin irritant, based on the erythema reading of 3 in two of the tested animals from the gradings at 24, 48 and 72 hours after patch removal.

Categories Display