3,5,5-trimethylhexanal

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1996 until April 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,5,5-trimethylhexanal

EC Number:

226-603-0

EC Name:

3,5,5-trimethylhexanal

Cas Number:

5435-64-3

Molecular formula:

C9H18O

IUPAC Name:

3,5,5-trimethylhexanal

Details on test material:

klare, farblose Flüssigkeit
Flüssigkeit erscheint optisch homogen
ph-Wert nicht messbar
Haltbarkeit > 1 Jahr
Reinheit 91,2 mass-% (Gas-Chromatographie)

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Remarks:

Mol: Russian/Chbb: HM

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Mollegard Breeding & Research Centre Ltd., Skensved, Denmark
- Age at study initiation: adult
- Weight at study initiation:2,3 - 2,6 kg
- Housing: conventional, single-housed
- Diet: ad libitum
- Water : ad libitum
- Acclimation period: at least 14 days
-sex: male

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 +/- 3 ° C
- Humidity (%):30 - 70 %
- Air changes (per hr): 15-fold/hr
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

single administration of 0.1 cm³ of the undiluted liquid
the liquid test substance was placed in the conjunctival sac of an eye

Duration of treatment / exposure:

24 hr

Observation period (in vivo):

24 h, 48 h, 72 h,
6, 8, 10 and 13 days after application of the test item

Number of animals or in vitro replicates:

3

Details on study design:

One day before the application of the test substance, the animals were examined for their general state of health. In addition, the eyes of the animals were exposed to binding eye damage and after instillation of a drop of fluorescein sodium solution (0.1%) by means of an eye lamp
possible damage to the cornea.

The liquid test substance (application volume: 0.1 cm.sup.3) was first dripped into the conjunctival sac of an eye only once in one animal because of the strong skin irritation effect of the test substance. The untreated eye served as a control. Because only light eye and eye mucosa stimuli were observed in this rabbit, a week later 2 animals were under the same test conditions aftertreated.

24 hours post-application, the treated eyes were examined in all animals after the fluorescein test with warm physiological saline-
solution. In animals 1, 2, and 3, the treated eye was treated 24, 48, and 72 hours, respectively, p.a. as well as 6 days p.a. (Animals 2 and 3) according to the assessment with warm physical NaCl. In the reacted animals, the fluorescein test 24, 48, and 72 h p.a. as well as after 6 days
carried out.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 6d

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: no effect

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: no effect

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

0.33

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48h

Results 7

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Reversibility:

other: no effect

Results 8

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Reversibility:

other: no effect

Results 9

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.11

Max. score:

1

Reversibility:

fully reversible within: 8 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 8d

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 6d

Results 12

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 6d

Results 13

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 13d

Results 14

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 8d

Results 15

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.55

Max. score:

2

Reversibility:

fully reversible within: 13 days

Results 16

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 6d

Irritant / corrosive response data:

see excecutive summary

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: GHS

Conclusions:

Not to be classifed as eye irritating accordingt to CLP Regulation (EC) No. 1272/2008

Executive summary:

For the test for acute eye and mucous membrane stimulation of TRIMETHYLHEXANAL, three rabbits were administered each 0.1 cm.sup.3 of the liquid test substance into the conjunctival sac of an eye. After an exposure time of 24 hours, the eyes were rinsed with warm physiological saline solution.

24 hours postapplication (p.a.) of the test substance, reactions were found in all three animals in the form of diffuse, crimson discoloration, so that individual vessels are difficult to recognize. Associated with this was a swelling over the normal, with partial removal of the lids (1 animal). The cornea was slightly opaque in an animal between 1/2 and 3/4 of the surface. The iris showed a circumcorneal hyperemia. At this observation time, 2 animals were without corneal and iris changes. 24 to 48 hours p.a. was observed in an animal eye secretion. 48 and 72 hours p.a. these eye and mucous membrane stimuli were observed in all three animals in a weakened form. The circumcorneal hyperemia on the iris occurred in an animal for 48 h. already no longer observed. The slight corneal opacity in an animal was no longer present on day 6 of the experiment. On this day was already an animal, on the 8th day were two animals and on the 13th day all three animals without eyesight.