Dioctyl ether

Endpoint summary

Description of key information

skin irritation (human): slightly irritating
eye irritating (rabbit): not irritating

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:

1998

Reliability:

1 (reliable without restriction)

Qualifier:

no guideline available

Principles of method if other than guideline:

Human Patch Test, GCP compliant

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report): Cetiol OE
- Lot/batch No.: 1029/8
- Physical state: Colorless liquid
- Purity: 99.9%

Species:

human

Strain:

other: caucasian

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

70 µL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

19 volunteers

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

1.39

Max. score:

1.39

Reversibility:

fully reversible

Interpretation of results:

GHS criteria not met

Conclusions:

The substances was rated as beeing non-irritant to humans.

Executive summary:

Dioctylether was tested in an occlusive 4-hr patch test. 19 volunteers were treated with the undiluted test substance and with a 50% concentration of dioctylether in 2-hexyl decanol. As a positive standard 2% Sodium Dodecyl Sulfate (SDS) was used which is classified as an irritant substance at a concentration of 2 %. The positive standard SDS 2% caused slight, moderate, strong and very strong reactions in 16 out of 19 volunteers, while the undiluted dioctylether caused slight and single moderate erythema in 8 out of 19 volunteers. The 50% concentration of dioctylether caused single slight erythema in 2 out of 19 volunteers. Thus, the reactions caused by dioctylether were significantly lower than the reactions caused by SDS 2%.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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:

1991

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

Specific details on test material used for the study:

- Name of test material (as cited in study report): di-n-octylether
- Physical state: colorless liquid
- Purity: >99.9%
- Stability: stable at temperatures up to 40°C

Species:

rabbit

Strain:

other: Kleinrussen Chbb:HM

Details on test animals or tissues and environmental conditions:

according to guideline

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

application volume: 0.1 mL undiluted

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h after instillation

Number of animals or in vitro replicates:

3

Details on study design:

according to guideline

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0.3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 2 - < 3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 1 - <= 1.5

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Remarks:

erythema

Basis:

mean

Time point:

24/48/72 h

Score:

>= 2.5

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Remarks:

edema

Basis:

mean

Time point:

24/48/72 h

Score:

> 2

Reversibility:

fully reversible within: 72 h

Table 1: Evaluation of the eye reactions

Animal No.	Hours after application
	1					24					48					72
	A	B	C	D	L	A	B	C	D	L	A	B	C	D	L	A	B	C	D	L
1270 1272 1273	0 0 0	0 0 0	1 2 1	1 1 0	1 1 0	0 0 0	0 0 0	1 1 0	0 1 0	0 0 0	0 0 0	0 0 0	0 1 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0

A effects on cornea (turbidity degree)

B effects on iris (intensity)

C erythema (conjunctival reaction)

D edema (conjunctival reaction)

L lacrimation

Interpretation of results:

GHS criteria not met

Conclusions:

Only mild effects were observed that were fully reversible within 3 days. Therefore, the substance is considered to be slightly irritating.

Executive summary:

An aliquot of 0.1 ml aqueous solution of the test article was instilled by a single application for a 24h contact into the eyes of 3 rabbits. The eyes were scored 24, 48 and 72 hours after application. The 24/48/72 hours mean scores were 0 for the cornea, 0 for the iris, 0.33 for the conjunctival erythema and 0.11 for the conjunctival oedema. The conjunctiva reactions abated completely within 72 hours. In summary, only mild effects were observed that were fully reversible. Therefore, the substance is considered to be slightly irritating. GHS criteria for classification and labelling are not fulfilled.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute skin irritation:

The acute dermal irritation of the test substance was tested undiluted (100% active matter) in 3 albino rabbits, strain New Zealand White. The contact time under semi-occlusive conditions was four hours. The 24/48/72 hours scores were 2.7 for the erythema and 2.3 for the oedema. The reactions disappeared totally within 21 days.

Dioctylether was tested in an occlusive 4-hr patch test. 19 volunteers were treated with the undiluted test substance and with a 50% concentration of dioctylether in 2-hexyl decanol. As a positive standard 2% Sodium Dodecyl Sulfate (SDS) was used which is classified as an irritant substance at a concentration of 2 %. The positive standard SDS 2% caused slight, moderate, strong and very strong reactions in 16 out of 19 volunteers, while the undiluted dioctylether caused slight and single moderate erythema in 8 out of 19 volunteers. The 50% concentration of dioctylether caused single slight erythema in 2 out of 19 volunteers. Thus, the reactions caused by dioctylether were significantly lower than the reactions caused by SDS 2%. Therefore, dioctylether was rated to be slightly irritating. A classification is not justified.

Based on the higher relevance of the test result obtained in the human study compared to the animal test, the human patch test has been used as key study.

Acute eye irritation:

An aliquot of 0.1 ml aqueous solution of the test article was instilled by a single application for a 24h contact into the eyes of 3 rabbits. The eyes were scored 24, 48 and 72 hours after application. The 24/48/72 hours mean scores were 0 for the cornea, 0 for the iris, 0.33 for the conjunctival erythema and 0.11 for the conjunctival oedema. The conjunctiva reactions abated completely within 72 hours. In summary, only mild effects were observed that were fully reversible. Therefore, the substance is considered to be slightly irritating.

Based on the reliability and relevance, this study has been used as key study.

Effects on skin irritation/corrosion: slightly irritating

Justification for classification or non-classification

Based on results of the key studies for skin irritation and for eye irritation, the substance does not need to be classified according to GHS (Regulation (EU) 1272/2008).