Hexa-2,4-dienoic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-03-31 - 1987-04-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, Guideline study

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)

Version / remarks:

Directive 84/449/EEC

Deviations:

no

GLP compliance:

yes

Remarks:

GLP compliance statement included

Test material

Test material information

Constituent 1

Reference substance name:

Hexa-2,4-dienoic acid

EC Number:

203-768-7

EC Name:

Hexa-2,4-dienoic acid

Cas Number:

110-44-1

Molecular formula:

C6H8O2

IUPAC Name:

hexa-2,4-dienoic acid

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Sorbinsäure
- Physical state: clourless, cristalline
- Analytical purity: > 99%
- Storage condition of test material: dark, below 4 °C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund; conventional breed
- Age at study initiation: 3 - 5 Month
- Weight at study initiation: 2,2 - 3,4 kg
- Housing: single cage, air-conditioned housing
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät-Kaninchen: ad libitum and hay about 15 g/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20°C +/- 3°C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr):- Photoperiod (hrs dark / hrs light):12h/12h

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: one ey of the animals treated the other was the control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 24, 48 und 72 hours after treatment and 7 and 14 days after treatment.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological NaCl solution at 37°C
- Time after start of exposure: 24 h

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: fluorescein
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: as described in OECD 405

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.66

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

The observed lesions were described with: haemorrhage of conjunctivae, obvious swelling of conjunctivae to swelling with lids about half closed, clear to white outflow,  white discoloured conjunctivae and nictitating membrane, diffuse areas of opacity. 
Full reversibility was noted after 14 days.

Other effects:

Neither clinical signs of toxicity nor mortality were observed in any of the animals during the study period.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Category 2 According to Regulation (EC) No. 1272/2008 Criteria used for interpretation of results: EU

Conclusions:

Sorbic acid is irritating to the eyes of the rabbits and has to be classified irritating to eyes (Category 2) according to the EU CLP Regulation (EC) No. 1272/2008