6-cyclopentylidenehexanal

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 11 February and 04 March 2013.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted in compliance with OECD Guideline No. 405 without any deviation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 April 2002.

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

Inspected on 2012-04-23&24 / Signed on 2012-07-18.

Test material

Test material information

Constituent 1

Reference substance name:

6-cyclopentylidenehexanal

Cas Number:

111998-18-6

Molecular formula:

C11 H18 O

IUPAC Name:

6-cyclopentylidenehexanal

Test material form:

liquid

Details on test material:

- Description: Colourless translucent liquid
- Storage conditions: Store in a cool, dry place with adequate ventilation. Keep away from incompatible materials, light, open flames, and high temperatures

Specific details on test material used for the study:

- Date received: 23 January 2013
- Storage condition of test material: 6°C±3°C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste – F40260 Linxe).
- Weight at study initiation: 2.81-2.91 kg
- Housing: the animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: foodstuff (SAFE - 112), ad libitum
- Water: tap-water, ad libitum
- Acclimation period: 5 day

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: between ten and fifteen changes per hour.
- Photoperiod: 12 hours light/12 hours dark.

IN-LIFE DATES: from 11 February to 04 March 2013.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

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

- Concentration (if solution): Test item was instilled, as supplied

Duration of treatment / exposure:

No washing was done

Observation period (in vivo):

Ocular examinations were performed on both right and left eyes 1, 24, 48 and 72 h & Days 7, 14 and 21 following treatment, according to a numerical evaluation.

Number of animals or in vitro replicates:

1

Details on study design:

TREATMENT
- 0.1 mL of the test item was instilled, as supplied, into the conjunctival sac of one eye. The other eye remained untreated serving as control.
- Initially, a single animal was treated. After consideration of the responses produced on day 21 in the first animal, two additional animals were not treated.

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: According to OECD guideline 405

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

probability of severe irritation

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days.

Remarks on result:

probability of mild irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

The ocular reactions observed during the study have been moderate to important and partially reversible:
- at the conjunctivae level: an important redness, noted 1 hour after the test item instillation and totally reversible on day 21, associated with an important chemosis, noted 1 hour after the test item instillation and totally reversible on day 21.
- at the iris level: a congestion, noted 1 hour after the test item instillation and totally reversible on day 7.
- at the corneal level: a moderate corneal opacity, noted 1 hour after the test item instillation and remaining on the last day of the test (day 21) with an important intensity.
A corneal neovascularization was noted on day 7 and was still observed on day 21.

Other effects:

None

Any other information on results incl. tables

Table 7.3.2/1: Individual and Mean Scores for Cornea, Iris and Conjunctivae

Rabbit Number and Sex	Time After Treatment	Corneal Opacity	Iris lesion	Conjunctival Redness	Conjunctival Chemosis
A2784 Female	1 h	2	1	3	3
	24 h	2	1	3	3
	48 h	2	1	3	2
	72 h	2	1	3	2
	Day 7	3	0	2	2
	Day 14	3	0	1	1
	Day 21	3	0	0	0
	Total (24, 48 and 72 h)	6	3	9	7
	Mean (24, 48 and 72 h)	2	1	3	2.3

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Under the test conditions, test material causes serious eye damage and classified in category 1 according to the annex I of the Regulation (EC) No. 1272 /2008 (CLP) and to the GHS.

Executive summary:

In an eye irritation study conducted according to OECD 405 guideline and in compliance with GLP, 1 New Zealand White female rabbit was exposed to 0.1 mL of test item in one eye while the contralateral eye remained untreated and served as control. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and from 7 to 21 days following treatment and graded according to the Draize method. Initially, a single animal was treated. After consideration of the responses produced on day 21 in the first animal, two additional animals were not treated.

At the conjunctivae level, an important redness was noted 1 hour after the test item instillation and totally reversible on day 21, associated with an important chemosis, noted 1 hour after the test item instillation and totally reversible on day 21. At the iris level, a congestion was noted 1 hour after the test item instillation and totally reversible on day 7. At the corneal level, a moderate corneal opacity was noted 1 hour after the test item instillation and remaining on the last day of the test (day 21) with an important intensity. A corneal neovascularization was noted on day 7 and was still observed on day 21.

 

Mean scores at 24, 48 and 72 h after exposure for one animal were 2.0, 1.0, 3.0, 2.3 for cornea, iris, conjunctivae and chemosis respectively.

 

Under the test conditions, test material causes serious eye damage and classified in category 1 according to the annex I of the Regulation (EC) No. 1272 /2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.