4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane

Endpoint summary

Description of key information

The key study for skin irritation found 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane not irritating in a reliable study conducted according to current guideline and in compliance with GLP (LPT, 2002). 

The key study for eye irritation found 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane not irritating in a reliable study conducted according to current guideline and in compliance with GLP (LPT, 2002). 

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:

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, Löhndorf D-24601/Post Wankendorf, GERMANY
- Age at study initiation: 4 months
- Weight at study initiation: 1.9-2.1 kg
- Housing: 1/cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 55 +/-15
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 2002-04-24 (estimated) To: 2002-04-28 (stated)

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 ml
- Concentration: neat

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48, 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: ca. 6 cm2
- % coverage: not stated
- Type of wrap if used: gauze patch held under semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not necessary

SCORING SYSTEM: according to OECD 404: scored for erythema and eschar (max 4) and oedema (max 4), at 1, 24, 48 and 72 h following exposure.

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:

No irritant response was reported at any of the observation times of 1, 24, 48 and 72 h.

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
1 h	0/0/0	0/0/0
24 h	0/0/0	0/0/0
48 h	0/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0	0/0/0
Reversibility*	n/a	n/a

 

Interpretation of results:

GHS criteria not met

Conclusions:

4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane has been tested for acute skin irritation in a semi-occlusive study conducted according to OECD TG 404 and in compliance with GLP. No irritant response was reported at any of the observation times of 1, 24, 48 and 72 h. It is concluded that the test substance is not irritating to the skin.

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

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

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, Löhndorf, GERMANY
- Age at study initiation: 2.5-3.5 months
- Weight at study initiation: 1.6-1.9 kg
- Housing: 1/cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3
- Humidity (%): 55 +/-15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 2002-04-29 To: 2002-05-03

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye is the control in each case.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: neat

Duration of treatment / exposure:

Single exposure, unwashed. Exposure until end of study (72 h).

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: unwashed

SCORING SYSTEM: After Draize, as given in OECD 405

TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein

Irritation parameter:

overall irritation score

Basis:

other: each of 3 animals

Time point:

other: mean 24, 48, 72 h

Score:

0

Max. score:

13

Reversibility:

fully reversible within: 24 h

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Minor (grade 1) corneal redness and chemosis in 1 of 3 animals at 1 h. No corneal or iridial effects. No other observations.

Other effects:

None.

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctival redness	Conjuctival chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/0/0	1/0/0
24 h	0/0/0	0/0/0	0/0/0	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 24h, 48h, 72h	0/0/0	0/0/0	0/0/0	0/0/0
Reversibility*	-	-	c	c
Average time (unit) for reversion	-	-	24 h	24 h

* Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Interpretation of results:

GHS criteria not met

Conclusions:

A reliable study, conducted according to OECD 405 and GLP, reported transient irritation - grade 1 corneal redness and chemosis at 1 h. The mean score (24, 48, 72 h) was 0/13 and 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane was found to be not irritating to the eyes of rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The key study for skin irritation found 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane not irritating in a reliable study conducted according to current guideline and in compliance with GLP (LPT, 2002). No irritant response was reported at any of the observation times of 1, 24, 48 and 72 h. It is concluded that the test substance is not irritating to the skin.

The key study for eye irritation found 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane not irritating in a reliable study conducted according to current guideline and in compliance with GLP (LPT, 2002).Transient irritation was observed in the study, including grade 1 corneal redness and chemosis at 1 h. The mean score (24, 48, 72 h) was 0/13 and therefore the test material was found to be not irritating to the eyes of rabbits.

Reliable supporting studies were also available for both skin and eye irritation (Dow Corning Corporation 1997), both were in agreement with the lack of irritant effects of the registered substance.

Justification for classification or non-classification

Based on the available information for 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane, no classification is required for skin or eye irritation in accordance with Regulation (EC) No. 1272/2008.