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Diss Factsheets

Administrative data

Description of key information

In the key skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, (3-chloropropyl)trimethoxysilane was not irritating to rabbit skin (Hüls, 1993c).

In the key eye irritation study, conducted according with OECD Test Guideline 405 and in compliance with GLP, (3-chloropropyl)trimethoxysilane was found to be non-irritant to rabbit eyes (Hüls, 1993d).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
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


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.
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.

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

 

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993/05/03-1993/05/07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
other: Small white ChBB:HM, SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

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

- Weight at study initiation: 2.3-2.6 kg

- Housing: Animals were individually caged in stainless steel cages.

- Diet: Ssniff K 4 Comprehensive Rabbit Chow (ad libitum) Ssniff Specialfoods GmbH, 59494 Soest.

- Water: ad libitum

- Acclimation period: Minimum of 14 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20 ± 3°C

- Humidity (%): 30-70

- Air changes (per hr): 15

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


Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye of each animal served as a control.
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 cm3 of the liquid test material was applied in the conjunctival sac of the right eye of each animal


Duration of treatment / exposure:
72 hour(s)
Observation period (in vivo):
24, 48, and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
- Washing (if done): Washing was carried out with a sodium chloride solution of body temperature.

-Time after exposure: 24 hours


SCORING SYSTEM: Draize 1959.


TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis 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:
A single instillation to the rabbit eye produced minimal conjunctival irritation in the three animals at one hour post exposure. The adverse effect was completely reversed by 48 hours.
Other effects:
No other effects reported.

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

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

1/0/0 

1/1/1 

 1/1/1

24 h

 0/0/0

0/0/0 

1/0/0 

 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

Reversibility*)

 -

c 

c 

c 

Average time (unit) for reversion

 

 24h

24h 

24h

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

 

Interpretation of results:
GHS criteria not met
Conclusions:
In the eye irritation study, conducted according with OECD Test Guideline 405 and in compliance with GLP, (3-chloropropyl)trimethoxysilane was found to be non-irritant to rabbit eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the key skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, (3-chloropropyl)trimethoxysilane was not irritating to rabbit skin. Following 4-hour dermal application of undiluted test material under semiocclusive dressing onto the skin of 6 rabbits, 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. Effects were fully reversible within 6 days and all symptoms subsided by day 17 (Hüls, 1993c).

In the key eye irritation study, conducted according with OECD Test Guideline 405 and in compliance with GLP, (3-chloropropyl)trimethoxysilane was found to be non-irritant to rabbit eyes. Following single instillation of undiluted test material into the eyes of 3 rabbits, minimal conjunctival irritation was observed in the three animals at one hour post exposure. The adverse effect was completely reversible by 48 hours (Hüls, 1993d).

Justification for classification or non-classification

Based on the available information, (3-chloropropyl)trimethoxysilane is not classified for skin and eye irritation according to Regulation (EC) No 1272/2008.