Octyloxirane

Endpoint summary

Description of key information

The homologues substance was irritating to the skin but not irritating to the eyes.

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:

02-09-1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliability assessed according to Klimisch scores.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

other: Mol:Russian

Details on test animals or test system and environmental conditions:

according to guideline

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

according to guideline

Observation period:

21 days

Number of animals:

3

Details on study design:

according to guideline

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.9

Max. score:

2

Reversibility:

fully reversible within: 21 days

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

1

Reversibility:

fully reversible within: 21 days

Irritant / corrosive response data:

The registered substance showed irritative properties which were fully reversible after 21 days.

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance has to be classified as "irritating to the skin".

Executive summary:

The skin irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 404 under GLP.

The undiluted test substance was applied unchanged under occlusive conditions for 4 hours to the shaved skin of three Mol:Russian rabbits, which were observed for 21 days post application. Over the first three days, clear erythema and oedema were observed in all rabbits, which reversed fully within 21 days. Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered irritating to the skin.

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:

1997-09-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliability has been assessed according to Klimisch scores.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

other: Mol:Russian

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

according to guideline

Observation period (in vivo):

according to guideline

Number of animals or in vitro replicates:

3

Details on study design:

according to guideline

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.9

Max. score:

2

Reversibility:

fully reversible within: 7 days

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The registered substance is not irritating to the eyes

Executive summary:

The eye irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 405 under GLP conditions. The amount of 0.1 mL of the undiluted substance was applied unchanged for 24 hours to the eyes of three Mol:russian rabbits, which were observed for 7 days post application. Over the first three days minimal effects on the conjunctiva were observed which did fully reverse within 3 days. Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is not considered to be eye irritating.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion

The skin irritation potential of the homologue test substance 2 -Decyloxirane was evaluated in a study according to OECD Test Guideline 404 under GLP. The undiluted test substance was applied unchanged under occlusive conditions for 4 hours to the shaved skin of three Mol:Russian rabbits, which were observed for 21 days post application. Over the first three days, clear erythema and oedema were observed in all rabbits, which reversed fully within 21 days. The test substance was considered to be irritating to the skin.

 

Eye irritation

The eye irritation potential of the homologues test substance 2 -decyloxirane was evaluated in a study according to OECD Test Guideline 405 under GLP conditions. The amount of 0.1 mL of the undiluted substance was applied unchanged for 24 hours to the eyes of three Mol:russian rabbits, which were observed for 7 days post application. Over the first three days minimal effects on the conjunctiva were observed which did fully reverse within 3 days. The test substance was not considered to be irritating to the eyes.

Justification for selection of skin irritation / corrosion endpoint:
Only study available

Justification for selection of eye irritation endpoint:
Only study available

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the irritating skin effects observed the test substance has to be classified as Skin Irrit. 2: H315: Causes skin irritation in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.

 

As no eye irritating effects were observed, classification for eye irritation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.