Octanoic acid

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

17 Jul - 10 Sep 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 April 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EC) No 440/2008, L142, Annex Part B

Version / remarks:

30 May 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

August 1998

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

BAYRISCHES LANDESAMT FÜR GESUNDHEIT UND LEBENSMITTELSICHERHEIT, LANDESINSTITUT FÜR ARBEITSSCHUTZ UND PRODUKTSICHERHEIT, München, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Octanoic acid

EC Number:

204-677-5

EC Name:

Octanoic acid

Cas Number:

124-07-2

Molecular formula:

C8H16O2

IUPAC Name:

octanoic acid

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand White Rabbits, Crl:KBL (NZW)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 20 weeks
- Weight at study initiation: 3.5 - 4.6 kg
- Housing: Rabbits were housed individually in ABS - plastic rabbit cages with a floor of 4200cm²
- Diet: autoclaved hay and Altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
The animals were derived from a controlled full-barrier maintained bredding system (SPF).

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr):at least 10 x
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 17 Jul 2011 To: 10 Sep 2011

Test system

Vehicle:

other: vaseline

Controls:

other: The untreated eye served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration: 70% (v/v)

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 100%
- Lot/batch no. (if required): 1004025-01

Duration of treatment / exposure:

24 h

Observation period (in vivo):

up to 11 days
Reading time points: 24, 48 and 72 h and every 24 h for up to 11 days

Number of animals or in vitro replicates:

4 females (including 1 animal for the preliminary test)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with physiological saline 0.9% NaCl
- Time after start of exposure: 24 h

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: mean over 24,48 and 72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

other: evaluated after fluoresceine application

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 11 days

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 6 days

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 4 days

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 4 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 11 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: mean over 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: mean over 24, 48 and 72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean over 24, 48 and 72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Irritant / corrosive response data:

The test item produced irritant ocular effects after application in 3 animals.
Conjunctival rednesses, chemosis and discharge were observed in 3 animals.
Upon fluoresceine examinations, corneal lesions were determined in 2 animals after 72 h.

A 70% mixture of octanoic acid in vaseline induced lesions of the iris in 2 out of 3 tested animals with a score equal to 1. Therefore, the test item has to be considered as eye irritant at a concentration of 70%.

Other effects:

Neither mortalities nor significant clinical signs of toxicity were observed (table 2).

Any other information on results incl. tables

Table 2: Clinical signs of toxicity

 

	Time after application	Systemic findings	Local findings
animal 1	1 – 72 h	no specific findings	mild discharge
	4 – 6 days	no specific findings	slight discharge
	7 – 9 days	no specific findings	no specific findings
animal 2	1 h	no specific findings	mild discharge
	24 h	no specific findings	slight discharge
	48 h – 6 days	no specific findings	no specific findings
animal 3	1 h – 24 h	no specific findings	mild discharge
	48 h	no specific findings	severe discharge
	72 h	no specific findings	slight discharge
	4 – 5 days	no specific findings	no specific findings
	6 and 8 days	no specific findings	slight discharge
	9 – 11 days	no specific findings	no specific findings

Table 3: Absolute body weight (kg)

 

	animal 1	animal 2	animal 3
start of study	4.4	4.6	3.5
72 h post application	4.6	4.7	3.4
end of observation period	4.5	4.6	3.5

Applicant's summary and conclusion

Interpretation of results:

other: Eye Cat. 2, H319 at a concentration of 70% according to Regulation (EC) No 1272/2008

Conclusions:

CLP: Eye irritation, Cat. 2, H319 at a concentration of 70%