Propanoic acid, 2-hydroxy-, C12-13-branched alkyl esters

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Oct - 01 Nov 1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. No data on GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters

IUPAC Name:

Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: colourless liquid
- Analytical purity: 100% (UVCB)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Conelli, Arona, Italy
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: the rabbits were caged individually in stainless steel cages (45.0 cm x 50.0 cm x 38.0 cm).
- Diet: standard pellet complete diet (Rieper), ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): at least 25 (maintained at a higher pressure than the outside atmosphere)
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 Oct 1993 To: 01 Nov 1993

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as the control

Amount / concentration applied:

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

Duration of treatment / exposure:

Single application without washing

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48 and 72 h, and 7 days

Number of animals or in vitro replicates:

6 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eye was not washed after exposure

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all 6 animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: Very slight conjunctivae observed in 3/6 rabbits at the 1 h reading time point

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all animals

Time point:

other: mean over 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

3/6 rabbits had very slight redness (conjunctivae) at the 1 h reading time point, which had cleared completely within 24 h. No other eye irritation effects were recorded. Therefore all the average scores were zero.

Other effects:

No further local or systemic effects were reported.

Any other information on results incl. tables

Table 1. Individual eye irritation scores

 

Rabbit #	Time	conjunctivae		iris	cornea
		redness	swelling
1	1 h	1	0	0	0
	24 h	0	0	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.0	0.0	0.0
2	1 h	0	0	0	0
	24 h	0	0	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.0	0.0	0.0
3	1 h	1	0	0	0
	24 h	0	0	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.0	0.0	0.0
4	1 h	1	0	0	0
	24 h	0	0	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.0	0.0	0.0
5	1 h	0	0	0	0
	24 h	0	0	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.0	0.0	0.0
6	1 h	0	0	0	0
	24 h	0	0	0	0
	48 h	0	0	0	0
	72 h 7 d	0 0	0 0	0 0	0 0
	Average*	0.0	0.0	0.0	0.0

*(24h+48h+72h)/3

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified