Registration Dossier

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:
04.03.2002 to 30.07.2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology KG
- Age at study initiation: 6-6.5 months
- Weight at study initiation: 2.4 kg
- Housing: Singly in restrainers to prevent a body turn
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 20


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 55± 15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09.04.2002 To: 20.04.2002

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 (volume or weight with unit): 0.5 ml



Duration of treatment / exposure:
Four
Observation period:
72 hours
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- % coverage: No data
- Type of wrap if used: gauze patch held in place with a semi-occlusive dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was not required.



SCORING SYSTEM: Draize and according to OECD TG 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: one hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Grade 1 erythema was observed in one animal from 60 minutes to 24 hours after patch removal. There were no changes in the other two animals at any time point.
Other effects:
No other effects observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a skin irritation study conducted according to OECD test guideline 404 and GLP (reliability score 1), 3-chloropropyl(dimethoxy)methylsilane was not irritating to the skin of Himalayan rabbits. There were no systemic effects.