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EC number: 219-983-4 | CAS number: 2591-76-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988-05-16 to 1988-06-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N-bis(2-methylpropyl)formamide
- EC Number:
- 219-983-4
- EC Name:
- N,N-bis(2-methylpropyl)formamide
- Cas Number:
- 2591-76-6
- Molecular formula:
- C9H19NO
- IUPAC Name:
- N,N-bis(2-methylpropyl)formamide
- Details on test material:
- - Name of the test substance used in the study report: Diisobutylformamid
- Purity: Please refer to section 1.2 for purity information.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, 6050 Offenbach/Main, Germany
- Age at study initiation:
- Weight at study initiation (mean): 2.92 kg
- Housing: Singly housing in stainless steel cages with wire mesh walk floors.
- Diet: Standardized animal laboratory diet (ca. 130 g/animal/day Kliba 341, Firma Klingentalmuehle AG, 4303 Kaiseraugstr, Switzerland)
- Water: About 250 mL tap water/animal/day
- Acclimation period: At least 8 days before the beginning of the study
- Animal identification. Ear tattoo
ENVIRONMENTAL CONDITIONS
- Temperature: 20 -24 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 hours dark/ 12 hours light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 mL to the conjunctival sac of the right eye
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- The substance was not washed out
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.9
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Symptoms |
|||
op |
ar |
red |
sw |
di |
||||
1 h |
1 |
1 |
2 |
0 |
2 |
2 |
3 |
|
2 |
0 |
0 |
0 |
2 |
2 |
2 |
||
3 |
0 |
0 |
0 |
2 |
2 |
2 |
||
24 h |
1 |
1 |
4 |
1 |
2 |
2 |
2 |
|
2 |
1 |
4 |
0 |
2 |
1 |
1 |
||
3 |
1 |
4 |
0 |
1 |
0 |
1 |
||
48 h |
1 |
1 |
4 |
0 |
2 |
1 |
0 |
PC/RE/S/LC |
2 |
1 |
4 |
1 |
2 |
2 |
2 |
||
3 |
1 |
3 |
0 |
1 |
0 |
1 |
||
72 h |
1 |
1 |
4 |
0 |
1 |
0 |
0 |
PC/RE/S/LC |
2 |
1 |
4 |
1 |
2 |
2 |
2 |
||
3 |
1 |
2 |
0 |
1 |
0 |
0 |
||
8 days |
1 |
1 |
2 |
0 |
0 |
0 |
0 |
PC/RE/LC/MV |
2 |
1 |
2 |
0 |
2 |
0 |
2 |
||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
||
15 days |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
RE/LC/MV |
2 |
1 |
1 |
0 |
1 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
||
21 days |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
RE/LC/MV |
2 |
1 |
1 |
0 |
0 |
0 |
0 |
||
3 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Mean |
1 |
1.0 |
|
0.3 |
1.7 |
1.0 |
|
|
2 |
1.0 |
|
0.7 |
2.0 |
1.7 |
|
||
3 |
1.0 |
|
0.0 |
1.0 |
0.0 |
|
||
Mean |
|
1.0 |
|
0.3 |
1.6 |
0.9 |
|
|
LC - Loss of corneal tissue
MV - Marginal vascularization of the cornea
PC - Pupil contracted
RE - Small retractions in the eyelids
S - Suppuration
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based in the effects of the test substance to the cornea, the test substance is regarded as causing irreversible damage to the eye.
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