Registration Dossier

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
Reference
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:
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: 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.

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:
4 March 2002 to 30 July 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, 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.
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.