Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data provided

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diethanolamine, Substance-No. XVII/144 (pure) and XVII/146 (technical grade)

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
- Weight at study initiation: 3.0 - 3.5 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: NaCl
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.05 ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
not applicable; substance was not washed out and remained in the conjunctival sac of the eye
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
- Washing (if done): none

Readings: 24 h, 48 h, 72 h and 8 days


SCORING SYSTEM: the original scoring system was converted into Draize scores

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 48 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 48 h
Score:
2
Max. score:
2
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 48 h
Score:
1
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48 h
Score:
2
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 48 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 72 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 72 h
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 72 h
Score:
2
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 72 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 8 days
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 8 days
Score:
1
Max. score:
4
Irritant / corrosive response data:
Product tested:(XVII/144; pure): 
Observations: Superficial corrosion, distinct corneal opacity (grade: ++), conjunctival  bleeding, distinct conjunctival redding, distinct edema, conjunctival  scale

Product tested: (XVII/146; technical grade):
Observations: Superficial corrosion, distinct corneal opacity (grade: ++), conjunctival  bleeding, distinct conjunctival redding, distinct edema, conjunctival  scale

There was no difference between the pure and the technical product in respect to eye irritation, therefore only the data for the pure product are shown in detail.

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

1 h

1

1

-

-

2

2

-

after 3 h corrosions of conjunctiva and nictitating membrane visible

2

1

-

-

1

2

-

corrosions of conjunctiva and nictitating membrane visible

24 h

1

2

-

-

2

2

-

corrosions of conjunctiva and nictitating membrane visible

2

2

-

-

1

2

-

mucosal bleedings

48 h

1

1

-

-

2

0

-

mucosal bleedings

2

2

-

-

1

1

-

mucosal bleedings

72 h

1

1

-

-

2

0

-

mucosal bleedings

2

2

-

1

0

-

mucosal bleedings

8 d

1

0

-

-

0

0

-

mucosal bleedings

2

1

-

-

0

0

-

mucosal bleedings, scars eyelid

Mean

24 -72 h

1

1.33

-

-

2

0.66

-

2

2

-

-

1

1

-

Mean

24-72 h

1-2

1.67

-

-

1.5

0.83

-

Applicant's summary and conclusion