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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted February 24, 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
; version September 19, 1984
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): diisotridecyl adipate

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, FRG
- Age at study initiation: adults
- Weight at study initiation: 2.99 - 3.48 kg
- Housing: fully air conditioned rooms; single housing in stainless steel cages with wire mesh walk floors, area 40 cm x 51 cm; no bedding in cages, sawdust in the waste trays
- Diet (e.g. ad libitum): KLIBA Labordiät 341, 4 mm; Klingenthalmühle AG, Kaiseraugst, Switzeland; ca. 130 g per animal and day
- Water (e.g. ad libitum): tap water, ca. 250 mL per animal and day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the test animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to OECD TG 405

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
2
Remarks on result:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0.778
Reversibility:
fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, and 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h

Any other information on results incl. tables

Eye irritating effects following a single instillation of 0.1 mL of diisotridecyl adipate to rabbit eyes (grading according to OECD TG 405)

 

Animal

Effect

Score
(time after application)

1 h

24 h

48 h

72h

Mean
(24 ¿ 48 h)

8 d

1

Cornea

0

0

0

0

-

0

Iris

0

0

0

0

-

0

Conjunctivae

2

1

1

1

1

0

Chemosis

0

0

0

0

-

0

2

Cornea

0

0

0

0

-

SD

Iris

0

0

0

0

-

SD

Conjunctivae

1

1

0

0

0.33

SD

Chemosis

0

0

0

0

-

SD

3

Cornea

0

0

0

0

-

SD

Iris

0

0

0

0

-

SD

Conjunctivae

1

2

1

0

1

SD

Chemosis

0

0

0

0

-

SD

 

SD = study discontinued

 

 

In general, the irritating effect of diisotridecyl adipate on the rabbit eye was week. No effects at all were seen for cornea, iris, and chemosis. As irritating effect, only conjunctival redness was observed. Mean conjunctivae scores including the 24 to 72 h readings for individual rabbits were 1 or lower.

 

Rabbit 2 and 3 did not show any effect after 72 h. Thus, the study was discontinued for these animals. For animal 1, all effects had subsided and were absent after 8 days.

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Diisotridecyl adipate showed only a very weak response in a primary eye irritation test (only conjunctivae effects grade 1 were observed, fully reversible within 1 to 8 d). Based on the results of this test, diisotridecyl adipate is not irritating to the eye.
Executive summary:

In a primary eye irritation study, 0.1 mL of diisotridecyl adipate was instilled into the conjunctival sac of one eye of each of 3 adult Vienna White rabbits for 24 hours. Eyes were not washed at the end of the exposure period. Eye irritation was scored 1 h, 24 h, 48 h, 72 h and 8 d after instillation of the test substance using the grading system of OECD test guideline 405 (Acute Eye Irritation/Corrosion). Animals then were observed for 72 h or 8 days dependent on the results of the test.

 

After treatment, only week effects on conjunctivae could be observed. No reaction was seen for cornea, iris, and chemosis. Conjunctival effects subsided with time and were fully absent after 48 h, 72 h and 8 d for rabbit 2, 3 and 1 respectively.

 

In this study, diisotridecyl adipate is not irritating to the eye according to EU regulations (Rossbacher/BASF 1992b).

 

This study is assessed as acceptable. It satisfies the guideline requirements (OECD TG 405) for an acute eye irritation/corrosion study.