3-(p-methoxyphenyl)-2-methylpropionaldehyde

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Jul 1979 to 26 Jul1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-(p-methoxyphenyl)-2-methylpropionaldehyde

EC Number:

226-749-5

EC Name:

3-(p-methoxyphenyl)-2-methylpropionaldehyde

Cas Number:

5462-06-6

Molecular formula:

C11H14O2

IUPAC Name:

3-(4-methoxyphenyl)-2-methylpropanal

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Nicholas Helf
- Age at study initiation: At least 8 weeks
- Weight at study initiation: not specified
- Housing: 2/ cage in suspended wire mesh cages (30"x18"x 18")
- Diet: Fresh purina rabbit chow was freely available
- Water: Fresh water was freely available
- Acclimation period: At least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 21 °C
- Any extraneous material which might produce eye irritation was excluded from the area. The room, exclusively reserved for rabbits on acute tests, was kept clean in accordance with the standards of AAALAC.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
0.1 mL was placed in the conjunctival sac of the eye

Duration of treatment / exposure:

The test material was placed once in the conjunctival sac of one eye. The lids were held together briefly to insure adequate distribution of the test material.

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

6 animals (5 males, 1 female)

Details on study design:

OBSERVATIONS:
The ocular reactions of the cornea, iris and conjunctiva were graded at 1, 2, and 3 days after dosing.

SCORING SYSTEM: Draize scoring system. The scores were interpreted as defined in 16 CFR 1500.42.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3, #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3, #4, #5 and #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #2, #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

not fully reversible within: 72 hours

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal: #1, #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 9

Irritation parameter:

chemosis score

Basis:

animal: #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

other: Not eye irritating

Remarks:

in accordance with EU CLP (1272/2008 and its updates)

Conclusions:

In an eye irritation study with rabbits, performed similar to OECD 405, no positive corneal , iridal or conjunctival scores were noted at any observation time. Based on the results of this study, the substance is not considered an eye irritant.

Executive summary:

A pre-guideline study, equivalent to OECD guideline 405, was performed to test eye irritation in six New Zealand White rabbits (at least 8 weeks old). 0.1 mL of undiluted test material was placed once in the conjunctival sac of one eye of each of the animals. The untreated eye severed as control. Observations were made after 24, 48 and 72 hours according to the Draize scoring system. No ocular reactions of the cornea and iris were observed. Ocular reactions of the conjunctiva (grade 1) were observed after 24 and 48 hours only, but were not assigned as positive test results. The results show that the substance is not irritating to the eye.