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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
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1987

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
BASF-Test according to Federal register 38, No. 187, § 1500.42, S. 27019 (27.09.1973)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Valeric acid
EC Number:
203-677-2
EC Name:
Valeric acid
Cas Number:
109-52-4
Molecular formula:
C5H10O2
IUPAC Name:
pentanoic acid
Details on test material:
- Name of test material (as cited in study report): Valeric acid, substance ID: 77/505
- Physical state: clear liquid
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Mean weight at study initiation: 2.8 kg
- Housing: individual
- Diet: Sniff ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): undiluted
Duration of treatment / exposure:
not applicable, test substance was not washed out and therefore remained in the eye till watered out by lacrimation
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 (1 male, 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: The Draize scoring system was used

Criteria for assessment of ocular lesions:

Cornea: opacity (op)*: Degree of density (area most dense taken for reading)

0 = No ulceration or opacity.
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible.
2 = Easily discernible translucent area, details of iris slightly obscured.
3 = Nacreous area, no details of iris visible, size of pupil barely discernible.
4 = Opaque cornea, iris not discernible through the opacity.

Area of cornea involved (ar):
1 = ≥ 0 ≤ ¼
2 = ≥ ¼ < ½
3 = ≥ ½ < ¾
4 = ≥ ¾

Conjunctivae
Redness (red)*: (Refers to palpebral and bulbar conjunctivae, cornea and iris)

0 = Blood vessels normal
1 = some blood vessels definitely hyperemic (injected)
2 = Diffuse, crimson color, individual vessels not easily discernible.
3 = Diffuse beefy red.

Chemosis (sw)*: Lids and/or nictitating membranes the lids and hairs
just adjacent to

0 = No swelling.
1 = Any swelling above normal (includes nictitating membranes).
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids more than half closed eye

Iris : (Table according to the OECD guideline no. 405 (adopted February 24, 1987), EEC directive 92/69, L 383A, B. and EPA/OPPTS, 870.2400 (August 1998))
0 = Normal
1 = Markedly deepened reddened, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 = No reaction to light, hemorrhage, gross destruction (any or all of these).

Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not include small amounts ob served in inner canthus of normal animals).
2 = Discharge with moistening of lids.
3 = Discharge with moistening of the lids and hairs, and considerable area around the eye


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
1-3
Time point:
other: 24, 48, 96 h
Score:
2.44
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: cornea area
Basis:
mean
Remarks:
1-3
Time point:
other: 24, 48, 96 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
1-3
Time point:
other: 24, 48, 96 h
Score:
0.88
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
1-3
Time point:
other: 24, 48, 96 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
1-3
Time point:
other: 24, 48, 96 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
other: discharge
Basis:
mean
Remarks:
1-3
Time point:
other: 24, 48, 96 h
Score:
3
Max. score:
3
Reversibility:
not reversible

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

1 h

1

2

4

0

2

2

1

nictitating membrane and mucosa of white colour

2

2

4

0

2

2

1

nictitating membrane and mucosa of white colour, pupil contracted

3

2

4

0

2

2

1

nictitating membrane and mucosa of white colour

24 h

1

2

4

0

2

2

3

nictitating membrane and mucosa of white colour

2

2

4

0

2

1

3

nictitating membrane and mucosa of white colour, pupil contracted

3

2

4

0

2

3

3

nictitating membrane and mucosa of white colour

48 h

1

2

4

0

2

2

3

nictitating membrane and mucosa of white colour, scars

2

2

4

1

2

2

3

nictitating membrane and mucosa of white colour, scars

3

2

4

1

2

2

3

nictitating membrane and mucosa of white colour

96 h

1

3

4

1

2

2

3

nictitating membrane and mucosa of white colour, scars

2

4

4

-

2

2

3

nictitating membrane and mucosa of white colour, scars

3

3

4

1

2

2

3

nictitating membrane and mucosa of white colour, scars

8 d

1

3

4

1

2

2

1

nictitating membrane and mucosa of white colour, scars

2

4

4

-

2

2

3

nictitating membrane and mucosa of white colour, scars

3

3

4

1

2

2

3

nictitating membrane and mucosa of white colour, pupil contracted, scars

Mean

24 -96 h

1

2.33

4

0.66

2

2

3

 

2

2.66

4

1

2

1.67

3

 

3

2.33

4

1

2

2.33

3

 

Mean

24-96 h

1-3

2.44

4

0.88

2

2

3

 

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU