Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,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:

February 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters

EC Number:

947-004-7

Molecular formula:

C28H56O6 - C29H58O6 - C30H60O6

IUPAC Name:

Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters

Test material form:

liquid

Details on test material:

product

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Padre Antonio - Mariano Comense (CO), Italy
- Age at study initiation: no data
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: singly in stainless steel cages (dimensions: 450x500x380 mm)
- Diet (e.g. ad libitum): standard pellet complete diet ad libitum by the authorized breeder Rieper
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
Temperature and humidity were regulated by a conditioning plant and were continuously recorded, no further details mentioned
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02-JUN-1992 To: 05-JUN-1992

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated left eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

at 1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: binocular loupe

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

other: 60 min

Score:

1.33

Max. score:

3

Results 2

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

24 h

Score:

0.67

Max. score:

3

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

48 h

Score:

0.33

Max. score:

3

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

for details see table below

Any other information on results incl. tables

Table: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0/0/0/0	0/0/0/0/0/0	2/1/1/2/1/1	0/0/0/0/0/0
24 h	0/0/0/0/0/0	0/0/0/0/0/0	1/0/0/1/1/1	0/0/0/0/0/0
48 h	0/0/0/0/0/0	0/0/0/0/0/0	1/0/0/1/0/0	0/0/0/0/0/0
72 h	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
Average 24h, 48h, 72h	0	0	0.33	0
Reversibility*)	-	-	c.	-
Average time for reversion	-	-	72 h	-

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters was not an eye irritant.

Executive summary:

An ocular irritation test was carried out on test material Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters according to OECD Guideline 405.

The test was performed by placing the test material in a single dose in the conjunctival sac of 6 albino male rabbits at a dose of 0.1 mL/animal. The animals eyes were examined 1, 24, 48 and 72 hours after the beginning of the test by means of a binocular loupe.

The ocular areas obvserved were the cornea, the iris and conjunctivae. The results showed a slight congestion of the conjunctivae in all rabbits treated after 60 minutes, still in 4 animals after 24 hours, in 2 animals after 48 hours. The irritation disappeared 72 hours after treament in all animals.

It was concluded that Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters is to be considered non-irritant to eyes.