1,4,7-trioxacyclotridecane-8,13-dione

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD), GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

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:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Remarks:

Department of Toxicology, BASF AG

Test material

Test material information

Constituent 1

Reference substance name:

2,3,7,8-tetrahydro-2,5,8-benzotrioxacycloundecine-1,9-dione

EC Number:

229-554-3

EC Name:

2,3,7,8-tetrahydro-2,5,8-benzotrioxacycloundecine-1,9-dione

Cas Number:

6607-34-7

Molecular formula:

C10H16O5

IUPAC Name:

1,4,7-Trioxacyclotridecane-8,13-dione

Details on test material:

- Name as cited in report: Adipic acid, cyclic ester with diethyleneglycol
- Analytical purity: ca. 90%
- Physical state: Solid/white
- Storage: refrigerated
- Lot/batch No.: B 74

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand White Chbb: NZW (SPF)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Sex: Male
- Age at study initiation: young adults
- Weight at study initiation: 3.61 kg - 3.88 kg
- Housing: singly
- Diet: ad libitum, Kliba Labordiaet (the feed was assayed for chemical and microbiological contaminants)
- Water: ad libitum, tap water (drinking water is regularly assayed for chemical contaminants)
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Left eye (no treatment).

Amount / concentration applied:

0.1 ml bulk volume (approx. 52 mg of the pulverised substance).

Duration of treatment / exposure:

24h

Observation period (in vivo):

1 h, 24 h 48 h, 72 h and 7 d after application

Number of animals or in vitro replicates:

3

Details on study design:

The test animals were weighed shortly before application of the test substance. The test substance was test substance was applied in a single dose to the conjunctival sac of the right eyelid. 24 h post application of the test substance, and shortly before the 24 h reading, the eyes of the test animals were washed with tap water. A check for mortality or moribund animals was made twice each workday and once on Saturdays, Sundays and on public holidays. Scoring of the changes to the eyes was performed according to guideline directives (adopted February 24, 1987).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24h, 48h, 72h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24h, 48, 72h

Score:

0.9

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24h, 48h, 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24h, 48h, 72h

Score:

ca. 0.67

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24h, 48h, 72h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24h, 48h, 72h

Score:

1.8

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24h, 48h, 72h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24h, 48h, 72h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24h, 48h, 72h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24h, 48h, 72h

Score:

0

Remarks on result:

other: Slight swelling (2 animals) and obvious swelling with partial eversion of the eyelids (1 animal) was observed 1 h post application of the test substance. However, the swelling was fully reversed in all animals within 24 h i.e. before the 24 h reading.

Other effects:

Slight discharge was observed in 1 animal 1 h post application of the test substance. The effect was fully reversible before the 24 h reading.

Any other information on results incl. tables

Tabulation of irritant response data for each individual animal at each observation time.

	Animal	Cornea score	Iris	Redness	Chemosis	Discharge
1h	01 02 03	0 0 0	0 0 0	2 1 2	1 1 2	0 0 1
24h	01 02 03	0 0 0	1 0 1	2 2 2	0 0 0	0 0 0
48h	01 02 03	0 0 0	1 1 1	2 2 1	0 0 0	0 0 0
72h	01 02 03	0 0 0	1 1 1	2 2 1	0 0 0	0 0 0
7d	01 02 03	0 0 0	0 0 0	0 0 0	0 0 0	0 0 0

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information