Benzaldehyde, 5-dodecyl-2-hydroxy-, oxime, branched

Eye irritation

Administrative data

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:

other: Assessment supported with ToxRTool (Schneider, K. et al. "ToxRTool", a new tool to assess the reliability of toxicological data. Toxicol Lett. 2009 Sep 10:189(2):138-44)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

7d observation period only

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: 16 CFR 1500.42

Deviations:

yes

Remarks:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[(1Z)-(hydroxyimino)methyl]-4-(2-methylundecyl)phenol

EC Number:

627-071-6

Cas Number:

1233873-37-4

Molecular formula:

C19H31NO2

IUPAC Name:

2-[(1Z)-(hydroxyimino)methyl]-4-(2-methylundecyl)phenol

Details on test material:

- Name of test material (as cited in study report): RD-5893; 5-Dodecylsalicylaldoxime
- Physical state: dark yellow semi-solid viscous liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 g

Duration of treatment / exposure:

no washout (6 rabbits) and wash-out after 4 seconds (3 rabbits)

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

9

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: no wash-out

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: no wash-out

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

2.44

Max. score:

3

Reversibility:

not fully reversible within: 7 d (4x score 1; 1x score 2)

Remarks on result:

other: no wash-out

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1.33

Max. score:

3

Reversibility:

not fully reversible within: 7 d (3x score 1; 1x score 2)

Remarks on result:

other: no wash-out

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.22

Max. score:

1

Reversibility:

fully reversible within: 3d

Remarks on result:

other: wash-out after 4 seconds

Results 6

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.22

Max. score:

1

Reversibility:

not fully reversible within: 7d (1x score 1)

Remarks on result:

other: wash-out after 4 seconds

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

2.33

Max. score:

3

Reversibility:

not fully reversible within: 7d (3x score 1)

Remarks on result:

other: wash-out after 4 seconds

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72h

Score:

1.89

Max. score:

3

Reversibility:

not fully reversible within: 7d (3x score 1)

Remarks on result:

other: wash-out after 4 seconds

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is labelled as Category 2 with regard to eye irritation (irritating to the eyes).

Executive summary:

The registered substance was tested in an acute eye irritation study in white rabbits according to the 16 CFR 1500.42 protocol. 0.1 ml of the test substance was instilled to the eyes of 9 animals, 6 of which received a wash-out rinse within 4 seconds after application. 3 animals did not receive the wash-out rinse. The study was performed under GLP conditions. After 7 days post-treatment, the conjunctivitis was not reversible in the rinse group but it can be expected that the conjunctivitis would have been reversibe within 21 days as required by the OECD guideline. In the non-rinse group the effects on the iris and cornea were reversible after 7 days of observation whereas the effects on the conjunctiva were not reversible although slight (grade 1). It can be expected that the effect would have been reversible if the observation period had been prolonged. Although the FDA study protocol is not fully in line with European study protocols, the results can be interpreted on the basis of Regulation (EC) 1272/2008. The test substance is considered to be irritating to the eyes (GHS Category 2).