Registration Dossier
Registration Dossier
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EC number: 242-056-0 | CAS number: 18171-19-2
Endpoint summary
Administrative data
Description of key information
In a skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP (LPT, 2002b, Reliability Score 1), 3-chloropropyl(dimethoxy)methylsilane (CAS 18171 -19 -2; EC No. 242 -056 -0) 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 in compliance with GLP (LPT, 2002c, Reliability Score 1), 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
- 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
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system 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:
- 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 in compliance with GLP (reliability score 1), 3-chloropropyl(dimethoxy)methylsilane was not irritating to the skin of Himalayan rabbits. There were no systemic effects.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- 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: ad libitum
- Water: 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: 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:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 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:
- 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 according to OECD Test Guideline 405 and in compliance with GLP (reliability score 1), 3-chloropropyl(dimethoxy)methylsilane was not irritating to the eyes of Himalayan rabbits. There were no systemic effects.
Reference
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 in compliance with 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 in compliance with 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 hours resepectively) and chemosis (fully reversible within 24 hours). However, since only 24/48/72 hours is considered (according to the OECD test 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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