3,5,5-trimethylhexanal

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; 50 μl instead of 100 μl test substance instilled; scoring system not according to OECD405). Study sufficient for evaluation of this endpoint.

Justification for type of information:

Read across is applied to a structural analogue

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1964

Report date:

1964

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

scoring system; application volume

Principles of method if other than guideline:

Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Usually 50μl or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The non- or saline treated adjacent eye served as a control.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexanal

EC Number:

204-596-5

EC Name:

2-ethylhexanal

Cas Number:

123-05-7

Molecular formula:

C8H16O

IUPAC Name:

2-ethylhexanal

Details on test material:

- Name of test material (as cited in study report): Äthylhexanal (German)
- Physical state: liquid
- Expiration date of the lot/batch: ca. 98 %
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: breeder
- Weight at study initiation: 2.02 kg and 2.38 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: one drop of saline was applied to the control eye

Amount / concentration applied:

50 µl

Duration of treatment / exposure:

Treatment was once. The eye was left unwashed.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

not reported

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48 h

Score:

0.75

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 24 h

Any other information on results incl. tables

Descriptive scores of the raw data have bee converted to Draize numerical scores.

Animal	Reading	Redness	Chemosis	Comment
1	1 h	1	0
2	1 h	1	1
1	3 h	2	0
2	3 h	1	1
1	24 h	0	0
2	24 h	2	0
1	48 h	0	0	cornea without substance related effects; end of experiment
2	48 h	1	0
1	72 h	/	/
2	72 h	0	0	cornea without substance related effects; end of experiment
mean	24-48 h	0,75	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; 50 µl instead of 100 µl test substance instilled; 2 instead of 3 animals; scoring system not according to OECD 405). The Study is however sufficient for evaluation of this endpoint. Marked erythema was observed in one out of two rabbits within the first 24 h, which was reversible within 48 h to 72 h.

The substance is a mild irritant to the eyes.