Registration Dossier
Registration Dossier
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EC number: 203-677-2 | CAS number: 109-52-4
Eye irritation
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:
- 1 978
- 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
- 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
Constituent 1
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
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