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Diss Factsheets

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
Study period:
November 23, 1981 - December 7, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with restrictions: - observation period of 14 days, but reversibility of the effects was not completed - no detailed information of the test substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(observation period of 14 days, but reversibility of the effects was not completed, no detailed information of the test substance)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates
EC Number:
279-632-6
EC Name:
Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates
Cas Number:
80939-62-4
Molecular formula:
Unspecified
IUPAC Name:
Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2 to 3 kg
- Housing: individually in metal cages
- Diet (ad libitum): standard rabbit food - NAFAG, No. 814
- Water (ad libitum): drinking water
- Acclimation period: min. of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye was not treated and served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
single treatment of all animals; in 3 of the 9 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 of the 9 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.

SCORING SYSTEM: as described in OECD Guideline 405

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 -48 -72 h
Score:
2.28
Max. score:
3
Reversibility:
not fully reversible within: 14 days (in 2 of 5 animals)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
2.11
Max. score:
4
Reversibility:
not fully reversible within: 14 days (in 3 of 5 animals)
Other effects:
Besides a transient anorexia of one animal on day 11, no symptoms were observed.
One female animal died on day 8 independently of the compound administration.
Besides spotted lungs no gross lesion were found.

Any other information on results incl. tables

Table 1: Rabbit eye irritation scores after single treatment with the test substance (m=males, f=females), here the results of the treated eyes, that were not rinsed, are given:

Observation time

Animal

Cornea

Iris

Conjuctiva

 

 

OP

AR

 

RED

SW

DI

24 H

1 (m)

0

0

0

2

1

0

 

2 (m)

1

4

0

3

3

1

 

3 (m)

1

1

0

2

2

2

 

4 (f)

1

3

0

2

2

1

 

5 (f)

0

0

0

2

2

1

 

6 (f)

1

2

0

2

3

2

48 H

1 (m)

0

0

0

2

1

0

 

2 (m)

1

3

0

3

2

1

 

3 (m)

0

0

0

2

1

1

 

4 (f)

1

1

0

2

2

1

 

5 (f)

0

0

0

2

2

1

 

6 (f)

2

2

0

3

3

2

72 H

1 (m)

0

0

0

2

2

0

 

2 (m)

1

1

0

2

2

1

 

3 (m)

0

0

0

2

2

0

 

4 (f)

1

1

0

3

3

2

 

5 (f)

0

0

0

2

2

0

 

6 (f)

2

2

0

3

3

2

7 days

1 (m)

0

0

0

1

2

0

 

2 (m)

0

0

0

2

2

0

 

3 (m)

0

0

0

1

1

0

 

4 (f)

0

0

0

2

2

0

 

5 (f)

0

0

0

1

2

1

 

6 (f)

1

1

0

2

2

1

14 days

1 (m)

0

0

0

1

1

4

 

2 (m)

0

0

0

0

1

2

 

3 (m)

0

0

0

0

0

0

 

4 (f)

-

-

-

-

-

-

 

5 (f)

0

0

0

0

0

0

 

6 (f)

0

0

0

1

1

4

Mean (24-48-72 h)

1 (m)

0.00

0.00

0.00

2.00

1.33

0.00

 

2 (m)

1.00

2.67

0.00

2.67

2.33

1.00

 

3 (m)

0.33

0.33

0.00

2.00

1.67

1.00

 

4 (f)

1.00

1.67

0.00

2.33

2.33

1.33

 

5 (f)

0.00

0.00

0.00

2.00

2.00

0.67

 

6 (f)

1.67

2.00

0.00

2.67

3.00

2.00

Mean

 

0.67

1.11

0.00

2.28

2.11

1.00

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this experiment the test material was found to cause irritation when applied to the rabbit eye mucosa.