Registration Dossier
Registration Dossier
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EC number: 221-906-4 | CAS number: 3277-26-7
Endpoint summary
Administrative data
Description of key information
The key skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, concluded that the registered substance, 1,1,3,3-tetramethyldisiloxane, is not irritating to rabbit skin (Laboratory of Pharmacology and Toxicology, 2002a).
The key eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, concluded that the registered substance, 1,1,3,3-tetramethyldisiloxane, is not irritating to rabbit eyes (Laboratory of Pharmacology and Toxicology, 2002b).
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
- 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: Approximately 6-6.5 months
- Weight at study initiation: 2.4-2.7 kg
- Housing: Singly in cages measuring 425 mm x 600 mm x 380 mm
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 55± 15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12 - 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 hours
- Observation period:
- Scores were taken 60 minutes, 24, 48 and 72 hours after patch removal. If necessary, the observations were continued on a daily basis for up to 14 days to determine the reversibility of the reactions.
- Number of animals:
- Three male rabbits.
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: Semi-occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
SCORING SYSTEM: According to OECD 404. - Irritation parameter:
- overall irritation score
- Basis:
- animal: 1, 2 and 3
- Time point:
- other: All
- Score:
- 0
- 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
- Other effects:
- No other effects reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The key skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, concluded that the registered substance, 1,1,3,3-tetramethyldisiloxane, is not irritating to rabbit skin.
- Executive summary:
Three Himalayan rabbits were exposed for four hours to 0.5 ml Siloxan HSi2 under semi-occlusive conditions on intact skin. The reactions of the intact skin were evaluated 60 minutes and then 24, 48 and 72 hours after patch removal. If necessary, the observations were continued on a daily basis for up to 14 days to determine the reversibility of the reactions. No skin reactions or other effects were observed at any of the time points in any of the rabbits.
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:
- 4 March 2002 to 30 July 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, branch Löhndorf, D-24601 Löhndorf/Post Wankendorf
- Age at study initiation: approximately nine months
- Weight at study initiation: 2.6 to 3.1 kg
- Housing: singly in cages measuring 425 mm x 600 mm x 380 mm.
- 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 (deviations from maximum range may have occurred e.g. during cleaning)
- Humidity (%): 55± 15 (deviations from maximum range may have occurred e.g. during cleaning)
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: for each animal, the left eye served as an untreated control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- Until the end of the observation period as the eyes were not rinsed
- Observation period (in vivo):
- Eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after administration
- Number of animals or in vitro replicates:
- Three females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
SCORING SYSTEM: According to OECD 405 (see "Any other information on materials and methods incl. tables")
TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein (24 hours after administration) - Irritation parameter:
- overall irritation score
- Basis:
- animal: 1, 2 and 3
- Time point:
- other: All
- Score:
- 0
- Reversibility:
- other: n/a
- Remarks on result:
- other: No signs of eye irritation were seen in any animal at any time point
- 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
- 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
- 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:
- No effects
- Other effects:
- No other effects observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The key eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, concluded that the registered substance, 1,1,3,3-tetramethyldisiloxane, is not irritating to rabbit eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key skin irritation study, conducted according to OECD Test Guideline 404 and in compliance with GLP, concluded that the registered substance, 1,1,3,3-tetramethyldisiloxane, is not irritating to rabbit skin (Laboratory of Pharmacology and Toxicology, 2002a). Following 4-hour application of undiluted test material onto the skin of three rabbits, no erythema or oedema were observed.
The key eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, concluded that the registered substance, 1,1,3,3-tetramethyldisiloxane, is not irritating to rabbit eyes (Laboratory of Pharmacology and Toxicology, 2002b). Following single instillation of undiluted test material into the eyes of three rabbits, no signs of eye irritation were observed. There were no signs of irritation to the cornea, iris or conjunctivae over the course of the study in any of the treated rabbits.
The available data for hexamethyldisiloxane (HMDS) have been included to
the dataset to support read across for genetic toxicity and skin
sensitisation.
Justification for classification or non-classification
Based on the available information on the registered substance, no classification is required 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
