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Diss Factsheets

Administrative data

Description of key information

The potential for skin and eye irritation/corrosion was tested in vivo according to OECD guidelines 404 and 405. No adverse effects were observed in the studies.

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:
May 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
31 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
17 July 1992
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Density: 828 g/L at 20°C

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Test animals:
Age on arrival: 9 weeks
Acclimatisation: 5 days
Bodyweight at start of study: 1.709-2.007 kg
Housing: individually housed in stainless steel cages
Diet: standard laboratory diet ad libitum
Water: tap water ad libitum

Environmental conditions:
Temperature: 20 +/-3°C
Humidity: 30-70%
Ventilation: 10 air changes per hour
Lighting: 12 hours light/dark cycle


Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 mL test material was distributed on a gauze patch measuring 2.5 x 2.5 cm and fixed to the clipped flank of the animal.
Duration of treatment / exposure:
4 h
Observation period:
Skin reactions were evaluated one hour after treatment then at 24, 48 and 72 hours after treatment
Number of animals:
3 males
Details on study design:
The patch loaded with the test material was fixed to the application site by means of semi occlusive adhesive tape.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0

Skin irritation scores

Animal no.

Time after removal of test material (hours)

1

24

48

72

A-B

8 (#1)

0-0

0-0

0-0

0-0

10 (#2)

0-0

0-0

0-0

0-0

12 (#3)

0-0

0-0

0-0

0-0

A = erythema (including ischemia, haemorrhages and incrustation)
B = oedema

Mean values for erythema and oedema for each rabbit scored 24, 48 and 72 h after treatment was zero.

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results obtained it is concluded that heptamethylethyltrisiloxane is non-irritating to skin under conditions of this study therefore no classification is required
Executive summary:

The primary skin irritation potential of heptamethylethyltrisiloxane was evaluated in three male New Zealand White rabbits. A dose of 0.5 mL of the test substance was placed on a gauze patch and applied to clipped intact dorsal skin of each rabbit for 4 hours. Skin reactions of erythema and oedema were scored 1, 24, 48 and 72 hours after removal of the patches. Skin irritation reactions were not observed in any animals during the observation period after the removal of patch.

Based on these results, heptamethylethyltrisiloxane is considered to be a non-irritant.

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:
28 November 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
31 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Density: 828 g/L at 20°C
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Test animals:
Age on arrival: 9 weeks
Acclimatisation: 5 days
Bodyweights at study start: 1.67-1.931 kg
Housing: individually housed in stainless steel cages
Diet: standard laboratory diet ad libitum
Water: tap water ad libitum

Environmental conditions:
Temperature: 20 +/- 3°C
Humidity: 30-70%
Ventilation: 10 air changes/h
Lighting: 12 h light/dark cycle
Vehicle:
unchanged (no vehicle)
Controls:
other: one eye of each animal was treated, the other eye served as a control
Amount / concentration applied:
0.1mL instilled into the conjuctival sac of one eye of each rabbit. Eyes were unwashed post treatment
Duration of treatment / exposure:
72 h
Observation period (in vivo):
The reactions of the eye were evaluated at 1,24,48 and 72 h after instillation
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Animal #1 showed conjuctival redness and chemosis, both grade 1 at the 1 h timepoint

 

Cornea

Iris

Conjunctiva redness

Conjunctiva chemosis

Time/animal

26 (#1)

28 (#2)

30 (#3)

26 (#1)

28 (#2)

30 (#3)

26 (#1)

28 (#2)

30 (#3)

26 (#1)

28 (#2)

30 (#3)

1 h

0

0

0

0

0

0

1

0

0

1

0

0

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

Average score
24-72 h

0

0

0

0

0

0

0.3

0

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results obtained, it is concluded that heptamethylethyltrisiloxane is slightly irritating to the eye under the conditions of this study, and does not require classification.
Executive summary:

The primary eye irritation potential of heptamethylethyltrisiloxane was evaluated in three male New Zealand White rabbits. A volume of 0.1 ml of the test substance was applied to one eye of each rabbit.The irritation reactions were observed 1, 24, 48 and 72 hours after application.  

In 1 out of 3 rabbits redness (grade 1) and chemosis (grade 1) in the conjunctiva were observed after application. I. Chemosis disappeared 24 hours after application and redness disappeared 48 hours after dosing. .

Based on the results of the study heptamethylethyltrisiloxane is considered to be a slight irritant to the rabbit eye and does not require classification.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No classification is warranted according to CLP (1272/2008/EC) classification criteria for irritation/corrosion.