3-methyl-5-phenylpentanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1987-06-02 to 1987-06-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted in accordance with the standardised guidelines OECD 405 and EU method B.5 and performed in line with GLP with a sufficient level of detail to assess the quality of the presented data. The study was performed on a similar substance to 3-methyl-5-phenylpentanol; the test substance in this study is the aldehyde of 3-methyl-5-phenylpentanol and as such is considered to be sufficient for read-across to address the endpoint.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

55066-49-4

EC Number:

611-227-5

Cas Number:

55066-49-4

IUPAC Name:

55066-49-4

Constituent 2

Reference substance name:

-

EC Number:

433-900-0

EC Name:

-

IUPAC Name:

433-900-0

Constituent 3

Reference substance name:

3-methyl-5-phenylpentan-1-al

IUPAC Name:

3-methyl-5-phenylpentan-1-al

Test material form:

other: liquid (not specified)

Details on test material:

- Physical state: Liquid, clear colourless

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: ENKI-Konjnenfarm, Someren, The Netherlands
- Weight at study initiation:2500-3500 g
- Housing: Housed individually in suspended, galvanised cages fitted with a wire-mesh floor and front.
- Diet: Standard laboratory rabbit diet ad libitum
- Water: Tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): at least 40 %
- Air changes (per hr): ca. 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Observation period (in vivo):

Up to 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing : The eyes were not washed out after administration of the test substance

SCORING SYSTEM:
CORNEA
- Opacity-degree of density (area most dense taken for reading)
No opacity - 0
Scattered or diffuse areas, details of iris clearly visible - 1
Easily discernible translucent area, details of iris slightly obscured - 2
Opalescent areas, no details of iris visible, size of pupil barely discernible - 3
Opaque, iris invisible - 4

IRIS
Normal - 0
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive) - 1
No reaction to light, haemorrhage, gross destruction (any or all of these) - 2

CONJUNCTIVAE
- Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
Vessels normal - 0
Vessels definitely injected above normal - 1
More diffuse, deeper crimson red, individual vessels not easily discernible - 2
Diffuse beefy red - 3

- Chemosis
No swelling - 0
Any swelling above normal (including nictitating membrane) - 1
Obvious swelling with partial eversion of lids - 2
Swelling with lids about half closed - 3
Swelling with lids about half closed to completely closed - 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: No effects observed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: No effects observed

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

other: 24 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

other: 48 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Remarks:

Chemosis

Basis:

mean

Time point:

other: 24 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

conjunctivae score

Remarks:

Chemosis

Basis:

mean

Time point:

other: 48 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

One hour after application, all three animals exhibited slight or moderate redness of the conjunctivae and slight or moderate swelling of the conjunctivae. Slight iritis was observed in one rabbit.

The eye effects had completely reversed in one rabbit at 24 hours, whereas slight redness of the conjunctivae and slight swelling of the conjunctivae persisted in the other two rabbits.

After 48 hours, the irritation had recovered completely in a second rabbit, slight redness of the conjunctivae and slight swelling of the conjunctivae was observed in the remaining rabbit.

After 72 hours, all irritation had resolved in the third rabbit.

Any other information on results incl. tables

Table 1: Results

Rabbit Number	Observation		Observation Time
			1 Hour	24 Hours	48 Hours	72 Hours
4477	Cornea Opacity		0	0	0	0
	Iris		0	0	0	0
	Conjunctivae	Redness	1	0	0	0
		Chemosis	1	0	0	0
4478	Cornea Opacity		0	0	0	0
	Iris		0	0	0	0
	Conjunctivae	Redness	2	1	1	0
		Chemosis	2	1	1	0
4479	Cornea Opacity		0	0	0	0
	Iris		1	0	0	0
	Conjunctivae	Redness	2	1	0	0
		Chemosis	2	1	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the undiluted test material, was considered to be non-irritating in the rabbit eye. All effects observed were mild in nature and were fully resolved by 72 hours.

Executive summary:

The eye irritation potential of the test substance was assessed in an in vivo study with rabbits, conducted to GLP and in accordance with the standardised guidelines OECD 405 and EU method B.5. The study was performed on the aldehyde of 3-methyl-5-phenylpentanol, and is considered a good reflection of the potential effects of this substance. Under the conditions of the test, the test substance was found to be non-irritating. Some mild irritation was noted during the course of the study, however this was mild in nature and any effects observed were fully resolved by the 72 hour observation period.