1,3-Dioxan-2-one

Endpoint summary

Description of key information

skin irritation/corrosion: 
In a primary dermal irritation study according to OECD 404 3 New Zealand White rabbits were dermally exposed to 500 mg 1,3-Dioxan-2-one (TMC) . In this study 1,3-Dioxan-2-one (TMC) is not a dermal irritant. 
Eye irritation:
In a primary eye irritation study 100 mg of 1,3-Dioxan-2-one (TMC) was instilled into the conjunctival sac of 3 New Zealand White rabbits. In this study, 1,3-Dioxan-2-one (TMC) is not an eye irritant.

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg, moistened with water

Duration of treatment / exposure:

4 h

Number of animals:

3

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48 and 72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48 and 72 h

Score:

0

Max. score:

4

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

In a primary dermal irritation study according to OECD Guideline 404 3 New Zealand White rabbits were dermally exposed to 500 mg 1,3-Dioxan-2-one (TMC) for 4 h under semi-occlusive conditions. Edema and erythema scores were 0 in all animals at all observation times. In this study 1,3-Dioxan-2-one (TMC) is not a dermal 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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Number of animals or in vitro replicates:

3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48 and 72 h

Score:

1.3

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal: #2, #3

Time point:

other: mean 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #3

Time point:

other: mean 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal: #1, #3

Time point:

other: mean 24, 48 and 72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: mean 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 6 days

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

In a primary eye irritation study 100 mg of 1,3-Dioxan-2-one (TMC) was instilled into the conjunctival sac of 3 New Zealand White rabbits. All effects were fully reversible within 6 days. In this study, 1,3-Dioxan-2-one (TMC) is not an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Human data on local irritation/corrosion are not available but relevant and reliable in vivo animal data regarding skin and eye irritation are available and are taken into consideration for 1,3 -Dioxan-2 -one (TMC):

Skin irritation/corrosion

In a primary dermal irritation study according to OECD 404 3 New Zealand White rabbits were dermally exposed to 500 mg 1,3-Dioxan-2-one (TMC) . In this study 1,3-Dioxan-2-one (TMC) is not a dermal irritant.

Eye irritation

In a primary eye irritation study 100 mg of 1,3-Dioxan-2-one (TMC) was instilled into the conjunctival sac of 3 New Zealand White rabbits. In this study, 1,3-Dioxan-2-one (TMC) is not an eye irritant.

Respiratory irritation

 

No data on the respiratory irritation of 1,3 -Dioxan-2 -one are available.

 

There are no data gaps for the endpoint irritation/corrosion. No human information is available for this endpoint. However, there is no reason to believe that these results would not be applicable to humans.

Justification for selection of skin irritation / corrosion endpoint:
Guideline study, GLP

Justification for selection of eye irritation endpoint:
Guideline study, GLP

Justification for classification or non-classification

Based on the available data 1,3 -Dioxan-2 -one (TMC) should not be classified as irritating to the skin or eye and requires no labelling according to Regulation (EC) 1272/2008.