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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:
1993/04/26-1993/05/19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

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

Test material

Constituent 1

Test animals

Species:
rabbit
Strain:
other: white russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS

- Source: Dr. Karl Thomae GmbH, Chemisch-Pharmazeutische Fabrik, 88400 Biberach an der Riss 1

- Weight at study initiation: 2.4-2.6 kg

- Housing: Animals were individually housed in stainless steel metal cages.

- Diet: Ssniff K 4 Comprehensive diet for rabbits (ad libitum), Ssniff Special foods GmbH, 59494 Soest.

- Water: ad libitum

- Acclimation period: minimum of 14 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20°C ± 3°C

- Humidity (%): 30-70

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12h/12h


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5 cm3 undiluted




Duration of treatment / exposure:
4 hour(s)
Observation period:
1, 24, 48, and 72 hours and 6, 8, 10, 14 and 17 days 
Number of animals:
6
Details on study design:
TEST SITE

- Area of exposure: intact skin

- % coverage: 6 cm2

- Type of wrap if used: After the application of the test material, the area of exposure was covered with a plaster and bandaged over.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The test substance was removed by washing with warm water and patted dry.

- Time after start of exposure: 4 hours


SCORING SYSTEM: The test sites were examined for evidence of irritation one, 24, 48, and 72 hours and 6, 8, 10, 14 and 17 days after patch removal, and scored according to Draize, 1959.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Erythema and edema were noted in all six animals at 24 and 48 hours after application.  At 72 hours, three animals still exhibited erythema and three animals exhibited edema, and dryness of the skin was observed.  Symptoms subsided by day 17.

Any other information on results incl. tables

Table 1: Irritant 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: 2

60 min

2/2/2/2/2/2

 2/2/2/1/1/2

24 h

 2/2/2/2/2/2

 2/2/2/1/1/2

48 h

 2/2/2/2/2/2

 1/2/2/1/1/2

72 h

 1/2/2/1/1/2

 0/2/2/1/1/1

Reversibility*)

c 

c 

Average time (unit) for reversion

6 days 

6 days 

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

 

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Remarks:
not classified according to Regulation (EC) No 1272/2008
Conclusions:
In the skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, (3-chloropropyl)trimethoxysilane was not irritating to rabbit skin.