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Registration Dossier
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EC number: 232-395-2 | CAS number: 8013-75-0 A combination of amyl alcohols, primarily isoamyl alcohol and 2-methyl-1-butanol. Other alcohols, acids, esters and aldehydes may also be present.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No 187, § 1500.41, S. 27019 (27/09/1973)
- Principles of method if other than guideline:
- Draize test
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-methylbutan-1-ol
- EC Number:
- 205-289-9
- EC Name:
- 2-methylbutan-1-ol
- Cas Number:
- 137-32-6
- Molecular formula:
- C5H12O
- IUPAC Name:
- 2-methylbutan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): 2-methylbutanol-1
- Physical state: liquid
- Analytical purity: ca. 99%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Age at study initiation: young adult animals
- Weight at study initiation: 2.71±0.17 kg (2.8±0.17 kg at the end of the study)
- Diet (e.g. ad libitum): Ssniff; ad libitum
- Water: ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- one application, not washed out
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
SCORING SYSTEM:
acc. to Federal Register, No. 187, § 1500.41, p. 27029, 1973:
Cornea
(A) Opacity-degree of density (area most dense taken for reading)
0 = No opacity
1 = Scattered or diffuse area, details of iris clearly visible
2 = Easily discernible translucent areas, details of iris slightly obscured
3 = Opalescent areas, no details of iris visible, size of pupil barely discernible
4 = Opaque, iris invisible
(B) Area of cornea involved
1 = One quarter (or less) but not zero
2 = Greater than one quarter, but less than half
3 = Greater than half, but less than three quarters
4 = Greater than three quarters, up to whole area
Iris
(A) Values
0 = Normal
1 = Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination af any thereof) iris still reacting to light (sluggish reactions is positive)
2 = No reaction to light, hemorrhage, gross destruction (any or all of these)
(3) Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
0 = Vessels normal
1 = Vessels definitely injected above normal
2 = More diffuse, deeper crimson red, individual vessels not easily discernible
3 = Diffuse beefy red
(B) Chemesis
0 = No swelling
1 = Any swelling above normal (includes nictitatinq membrane)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids about half closed to completely closed
(C) Discharge
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals
2 = Discharge with moistening of the lids and hairs just adjacent to 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
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8d (in 1/6 animals)
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritant / corrosive response data:
- 24-72 h: Slight opacity of the cornea, ciliary injections in the iris, conjunctivae: obvious redness, obvious to slight swelling, secretion.
8 days: slight corneal opacity in 5/6 animals, slight redness of conjunctivae in 5/6, obvious redness in 1/6 animals, slight secretion in 2/6 animals.
Overall irritation score: 34 of maximally 110 (not reversible within 8 d). - Other effects:
- Scar formation of eyelids was observed in 2 animals 24 hours after treatment and in a total of 3 animals from day 2 up to the end of the observation period.
Any other information on results incl. tables
Results:
| Readings | Animal | cornea | Iris | conjunctiva | Symptons | |||
| opacity | area | redness | swelling | discharge | ||||
| 24 h | 1 | 1 | 4 | 1 | 2 | 2 | 1 | m,sc |
| 2 | 1 | 4 | 1 | 2 | 2 | 1 | m | |
| 3 | 1 | 4 | 1 | 2 | 2 | 2 | m, sc | |
| 4 | 1 | 4 | 1 | 2 | 2 | 2 | ||
| 5 | 1 | 4 | 1 | 2 | 2 | 2 | m | |
| 6 | 1 | 4 | 1 | 2 | 2 | 2 | m | |
| 48 h | 1 | 1 | 4 | 1 | 2 | 1 | 1 | m, sc |
| 2 | 1 | 4 | 1 | 2 | 1 | 1 | m | |
| 3 | 1 | 4 | 1 | 2 | 2 | 1 | m, sc | |
| 4 | 1 | 4 | 1 | 2 | 1 | 1 | sc | |
| 5 | 1 | 4 | 1 | 2 | 1 | 1 | m | |
| 6 | 1 | 4 | 1 | 2 | 1 | 1 | m | |
| 72 h | 1 | 1 | 4 | 1 | 2 | 1 | 1 | m, sc |
| 2 | 1 | 4 | 1 | 2 | 1 | 1 | m | |
| 3 | 1 | 4 | 1 | 2 | 1 | 1 | m, sc | |
| 4 | 1 | 4 | 1 | 2 | 1 | 1 | m, sc | |
| 5 | 1 | 4 | 1 | 2 | 1 | 1 | m | |
| 6 | 1 | 4 | 1 | 1 | 0 | 1 | m | |
| 8 d | 1 | 1 | 1 | 0 | 1 | 0 | 0 | sc |
| 2 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| 3 | 1 | 4 | 1 | 2 | 0 | 1 | sc | |
| 4 | 1 | 3 | 0 | 1 | 0 | 1 | sc | |
| 5 | 1 | 1 | 0 | 1 | 0 | 0 | ||
| 6 | 1 | 1 | 0 | 1 | 0 | 0 | ||
| mean 24 - 72 h | 1 | 1.0 | 4.0 | 1.0 | 2.0 | 1.3 | 1.0 | |
| 2 | 1.0 | 4.0 | 1.0 | 2.0 | 1.3 | 1.0 | ||
| 3 | 1.0 | 4.0 | 1.0 | 2.0 | 1.7 | 1.3 | ||
| 4 | 1.0 | 4.0 | 1.0 | 2.0 | 1.3 | 1.3 | ||
| 5 | 1.0 | 4.0 | 1.0 | 2.0 | 1.3 | 1.3 | ||
| 6 | 1.0 | 4.0 | 1.0 | 1.7 | 1.0 | 1.3 | ||
| mean | 1.0 | 4.0 | 1.0 | 1.9 | 1.2 | 1.3 | ||
m: myosis
sc: scar
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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