5-methylheptan-3-one oxime

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Abstract only

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1966

Report date:

1966

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

Principles of method if other than guideline:

The method of procedure is that suggested by Dr. Draize and described in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", published by the Association of Food and Drug Officials of the United States.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

5-methylheptan-3-one oxime

EC Number:

245-010-8

EC Name:

5-methylheptan-3-one oxime

Cas Number:

22457-23-4

Molecular formula:

C8H17NO

IUPAC Name:

5-methylheptan-3-one oxime

impurity 1

Reference substance name:

(E)-3,4-dimethylhexan-2-one oxime

IUPAC Name:

(E)-3,4-dimethylhexan-2-one oxime

impurity 2

Reference substance name:

(Z)-3,4-dimethylhexan-2-one oxime

IUPAC Name:

(Z)-3,4-dimethylhexan-2-one oxime

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: study refers to "albino rabbits" which implies that new zealand whites were used, but this cannot be confirmed.

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Vehicle:

other: 80% Propylene Glycol

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): reported as 2.0% solution MHO in 80% Propylene Glycol

VEHICLE
- Concentration (if solution): 80% Propylene Glycol
- Purity: no data

Duration of treatment / exposure:

7 days (no wash)

Observation period (in vivo):

Both the treated and control eyes were examined every 24 for four days and then again on the seventh day.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing was carried out
- Time after start of exposure: n/a

SCORING SYSTEM:
__________________________________
Cornea
A. Opacity-Degree of Density (area which is most dense is taken for reading)
Scattered or diffuse area-details of iris clearly visible = 1
Easily discernible translucent areas, details of iris slightly obscured = 2
Opalescent aress, no details of iris visible, size of pupil barely discernible = 3
Opaque, iris invisible = 4
B. Area of Cornea Involved
One quarter (or less) hut not zero = 1
Greater than one quarter-less than one-half = 2
Greater than one-haH less than three quarters = 3
Greater than three quarters up to whole area = 4
Score equals A x B x 5 Total maximum = 80
__________________________________
lris
A. Values
Folds ahove normal, congestion, swelling, circumcorneal injection (anyone or all of these or combination of any thereof), iris still reacting to light (sluggish reaction if positive) = 1
No reaction to light, hemorrhage; gross destruction (anyone or all of these) = 2
Score equals A x 5 Total possible maximum
__________________________________
Conjunctivae
A. Redness (refers to palpebral conjunctivae only)
Vessels definitely injected above normal = 1
More diffuse, deeper crimson red, individual vessels not easily discernible = 2
Diffuse beefy red = 3
B. Chemosis
Any swelling above normal (includes nictitating membrane) = 1
Obvious swelling with partial eversion of the lids = 2
Swelling with lids about half closed = 3
Swelling with lids about half closed to completely closed = 4
C. Discharge
Any amount different from normal (does not include small amount observed in inner canthus of normal animals) = 1
Discharge with moistening of the lids and hairs just adjacent to the lids = 2
Discharge with moistening of the lids and considerable area around the eye = 3
Score (A + B + C) x 2 Total maximum = 20
__________________________________

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

20

Reversibility:

not specified

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

10

Reversibility:

not specified

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

20

Reversibility:

fully reversible

Irritant / corrosive response data:

Instillation of the test material into rabbits' eyes, in the manner described, produced a very slight irritation only to the conjunctivae. On the second day of observation the treated eyes were normal.

Any other information on results incl. tables

Obervations:

Rabbit #1	day 1	day 2	day 3	day 4	day 7
Cornea-A-Opacity	0	0	0	0	0
Cornea-B-Area	0	0	0	0	0
Score = A x B x 5	0 x 0 x 5 = 0
Iris-A-Values	0	0	0	0	0
Score = A x 5	0 x 5 =0
Conjunctivae-A-Redness	1	0	0	0	0
Conjunctivae-B-Chemosis	0	0	0	0	0
Conjunctivae-C-Discharge	0	0	0	0	0
Score = (A+B+C)x2	(1 + 0 + 0) x 2 = 2

Rabbit #2	day 1	day 2	day 3	day 4	day 7
Cornea-A-Opacity	0	0	0	0	0
Cornea-B-Area	0	0	0	0	0
Score = A x B x 5	0 x 0 x 5 = 0
Iris-A-Values	0	0	0	0	0
Score = A x 5	0 x 5 =0
Conjunctivae-A-Redness	1	0	0	0	0
Conjunctivae-B-Chemosis	0	0	0	0	0
Conjunctivae-C-Discharge	0	0	0	0	0
Score = (A+B+C)x2	(1 + 0 + 0) x 2 = 2

Rabbit #3	day 1	day 2	day 3	day 4	day 7
Cornea-A-Opacity	0	0	0	0	0
Cornea-B-Area	0	0	0	0	0
Score = A x B x 5	0 x 0 x 5 = 0
Iris-A-Values	0	0	0	0	0
Score = A x 5	0 x 5 =0
Conjunctivae-A-Redness	1	0	0	0	0
Conjunctivae-B-Chemosis	0	0	0	0	0
Conjunctivae-C-Discharge	0	0	0	0	0
Score = (A+B+C)x2	(1 + 0 + 0) x 2 = 2

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to Regulation EC 1272/2008, CLP, a substance should be considered for calssification as Eye irrit. 2 - H319 where a conjunctival redness and/or conjunctival oedema (Chemosis) score of ≥2 is observed. Since this is not the case for according to this data (only a redness score of 1 was observed in each observation, diminishing after 24h)

Executive summary:

Three healthy albino rabbits had 0.1 ml. of a 2% solution of Stemone in 80% Propylene glycol, instilled into the right eye with no further treatment. The untreated left eye of each animal served as its own control. Both the treated and control eyes were examined every twenty-four hours for four days and then again on the seventh day. The recorded observations, based on the the Draize scale for scoring ocular lesions, indicated that, according to the classification recommendations described in regulation EC 1272/2008 (CLP), the substance should not be considered irritating to the eyes based on the results of this study.