Registration Dossier

Administrative data

Description of key information

In a skin irritation study conducted according to OECD test guideline 404 and GLP (LPT, 2002b), 3-chloropropyl(dimethoxy)methylsilane was not irritating to the skin of Himalayan rabbits. There were no systemic effects.  

In an eye irritation study conducted according to OECD test guideline 405 and GLP (LPT, 2002c), 3-chloropropyl(dimethoxy)methylsilane was not irritating to the eyes of Himalayan rabbits. There were no systemic effects.  

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:
04.03.2002 to 30.07.2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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
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
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.
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.
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:
04.03.2002 to 30.07.2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology KG
- Age at study initiation: Males were approximately five months and the female nine months.
- Weight at study initiation: Males: 2.5-2.6 kg and female: 2.6 kg
- Housing: for eight hours following instillation the animals were kept singly in restrainers which allowed free head movements but prevented a complete body turn and wiping of the eyes with paws.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 55 ±15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09.04.2002 To: 03.05.2002
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml



Duration of treatment / exposure:
Eyes were not rinsed, so exposure lasted until the test substance was cleared naturally from the eye.
Observation period (in vivo):
72 hours (at 1, 24, 48 and 72 hours)
Number of animals or in vitro replicates:
Two males and one female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing done


SCORING SYSTEM: according to Draize and OECD TG 405.


TOOL USED TO ASSESS SCORE: 24 hours after instillation the eyes were treated additionally with fluorescein and examined.
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:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
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
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
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:
Grade 1 conjunctival redness was noted in two animals one hour after instillation and in one of these animals after 24 hours.
Grade 1 conjunctival chemosis was observed in the same two animals, one hour after instillation.
The cornea and iris were not affected.
Other effects:
No other effects reported.
Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study conducted to OECD TG 405 and GLP (reliability score 1), (3-chloropropyl)dimethoxymethylsilane was not irritating to the eyes of Himalayan rabbits. There were no systemic effects.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a skin irritation study conducted according to OECD test guideline 404 and GLP (LPT, 2002b), 3-chloropropyl(dimethoxy)methylsilane was not irritating to the skin of Himalayan rabbits. In total, three rabbits received semiocclusive application of 0.5 ml of the test substance. Following exposure for one hour, observed skin reactions were limited to mild erythema in one of three animals only, however, the effects of this was fully reversible after 48 h. There were no systemic effects.  

In an eye irritation study conducted according to OECD test guideline 405 and GLP (LPT, 2002c), 3-chloropropyl(dimethoxy)methylsilane was not irritating to the eyes of Himalayan rabbits. The test substance was applied as a single instillation into the conjunctival sac of the rabbits. No irritation effect was observed for cornea opacity, iris irritation, conjunctivae or chemosis. However, following exposure to the test substance for one hour, it was observed that two of three animals had conjunctivae (fully reversible within 24 and 48 h respectively) and chemosis (fully reversible within 24 h respectively). However, since 24/48/72 h is considered only (according to OECD guideline), this is established as non irritant to the eyes. There were no systemic effects.  

Skin and eye irritation tests on all analogue group substances are included in support of the read-across justification for other endpoints.

Justification for classification or non-classification

Based on the available in vivo data, 3-chloropropyl(dimethoxy)methylsilane is not classified for skin or eye irritation according to Regulation (EC) No 1272/2008.