Octamethylcyclotetrasiloxane

Endpoint summary

Description of key information

In the key skin irritation study (Laboratoires de Recherches de la Societe des Usines, 1971), D4 was not irritating to rabbit skin. Furthermore, acute and repeated-dose dermal toxicity studies in rats showed no indication of adverse local effects on the skin of rats or rabbits (see Sections 7.2.3 and 7.5.2).

In the key eye irritation study (Dow Corning Corporation, 1997e) D4 was not irritating to the eyes of rabbits.  Repeated dose inhalation studies generally show signs of respiratory tract irritation.

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:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The study report lacked many details regarding the test animals and environmental conditions.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

other: albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Source: Not stated

- Age at study initiation: Not stated

- Weight at study initiation: 2.3 - 2.8 kg

- Housing: Not stated

- Diet (e.g. ad libitum): Not stated

- Water (e.g. ad libitum): Not stated

- Acclimation period: Not stated

ENVIRONMENTAL CONDITIONS

- Temperature (°C): Not stated

- Humidity (%): Not stated

- Air changes (per hr): Not stated

- Photoperiod (hrs dark / hrs light): Not stated

Type of coverage:

not specified

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml to intact and abraded skin

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE

- Area of exposure: 4cm diameter

SCORING SYSTEM: Draize

Irritation parameter:

overall irritation score

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: No skin reactions were observed at any time for intact skin. For abraded skin, desquamation was observed but was fully resolved after 72 hours.

Irritation parameter:

erythema score

Remarks:

intact skin

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

Remarks:

intact skin

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

Remarks:

intact skin

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

intact skin

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Remarks:

intact skin

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

Remarks:

intact skin

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

Remarks:

intact skin

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

Remarks:

intact skin

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Remarks:

intact skin

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Other effects:

No data

No skin reactions were observed at any time for intact skin. For abraded skin, desquamation was observed but was fully resolved after 72 hours.

Interpretation of results:

GHS criteria not met

Conclusions:

In a study that pre-dates GLP but was similar to OECD 404, D4 produced to skin reactions in intact with of rabbits. It is therefore not irritant according to EU criteria.

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:

supporting study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

2 animals were used instead of 3

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS

- Age at study initiation: adult

- Weight at study initiation: 3-4 kg

- Housing: Individually housed

Vehicle:

not specified

Controls:

other: Untreated eye

Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1ml

- Concentration (if solution): undiluted

Duration of treatment / exposure:

Single intillation, not rinsed.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE

- Washing (if done): not rinsed


SCORING SYSTEM: Draize

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No eye irritation was observed.

Other effects:

None reported.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was determined to be not irritating in a reliable study conducted according to an appropriate test protocol. Not conducted according to GLP. Although only 2 animals were used instead of 3 as specified in the test guideline, this does not affect the outcome of the study since no effects were seen in the test animals.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

In the key skin irritation study (Laboratoires de Recherches de la Societe des Usines, 1971) 0.5 ml of undiluted D4 was applied to the shaved skin (intact and abraded) of 6 albino rabbits for 24 hours. There was no information on the type of dressing used to hold the D4 in place. The animals were then observed for 72 hours for skin reactions and signs of toxicity. Skin reactions were scored according to the scoring system of Draize. No skin reactions were observed at any time in intact skin. For abraded skin, desquamation was observed but was fully resolved after 72 hours. Therefore, D4 was not irritating to the skin under the conditions of this study. Supporting studies confirm the conclusion that D4 is not a skin irritant. Furthermore, acute and repeated-dose dermal toxicity studies in rats showed no indication of adverse local effects on the skin of rats or rabbits.

In the key eye irritation study (Dow Corning Corporation, 1997e) 0.1 ml of undiluted D4 was administrated into the right eye of each of three New Zealand white rabbits. The eyes were rinsed with lukewarm water 24 hours after instillation, and were then scored for irritation at 1, 24, 48 and 72 hours following test substance administration. D4 was determined to not be irritating to eyes under the conditions of this study. Supporting studies confirm the conclusion that D4 is not irritating to the eyes.

Justification for classification or non-classification

Based on the available in vivo skin and eye irritation data, D4 does not require classification for skin and eye irritation according to Regulation (EC) No. 1272/2008.