Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes
Remarks:
Department of Toxicology, BASF AG

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24h, 48h, 72h
Score:
0
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
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24h, 48h, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
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
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24h, 48h, 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
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
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24h, 48h, 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24h, 48h, 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
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
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