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EC number: 240-596-1 | CAS number: 16529-56-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not stated
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study comparable to OECD 405 (Draize method) with minor deviation (no details on test animals, housing and feeding). The purity is not indicated.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : minor deviation (no details on test animals, housing and feeding)
- Principles of method if other than guideline:
- Draize test
- GLP compliance:
- not specified
- Remarks:
- But the study was performed before GLP statement.
Test material
- Reference substance name:
- 2-methyl-3-butenenitrile
- EC Number:
- 240-596-1
- EC Name:
- 2-methyl-3-butenenitrile
- Cas Number:
- 16529-56-9
- Molecular formula:
- C5H7N
- IUPAC Name:
- 2-methylbut-3-enenitrile
- Details on test material:
- - Name of test material (as cited in study report): 2-methyl-3-butenenitrile
- Substance type: no data
- Physical state: light yellow liquid
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: no data
- Age at study initiation: no data
- Weight at study initiation: From 2.0 kg to 3.0 kg
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g (or mL)
- Concentration (if solution): no data - Duration of treatment / exposure:
- Eyes were not rinsed.
- Observation period (in vivo):
- 7 days. Changes were observed at 1, 24, 48, 72, 96 and 168 hours.
- Number of animals or in vitro replicates:
- 4 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: no
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- other: Discharge
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Irritation parameter:
- other: acute irritation score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 9.75
- Irritant / corrosive response data:
- 2-methyl-3-butenenitrile produced chemosis (mean score 0.5), conjunctival redness (mean score 0.5), and Iridial lesions (mean score 0.33) which were completely reversed after 4 days.
- Other effects:
- No other effect
Any other information on results incl. tables
Table 7.3.2/1: Occular irritation test with 2M3BN
Table 7.3.2/1: Mean Irritant/corrosive response data for all animals at each observation time up to removal from the test
Score at time point / Reversibility |
Cornea Max. score: 4 |
Iris Max. score: 2 |
Conjunctivae Max. score: 3 |
Chemosis Max. score: 4 |
Discharge Max. score: 3 |
60 min |
0.00 |
1.00 |
2.00 |
2.00 |
2.00 |
24 h |
0.00 |
1.00 |
1.00 |
1.00 |
0.00 |
48 h |
0.00 |
0.00 |
0.5 |
0.25 |
0.00 |
72 h |
0.00 |
0.00 |
0.00 |
0.25 |
0.00 |
96 h |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
168 h |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Average 24h, 48h, 72h |
0.0 |
0.33 |
0.5 |
0.5 |
0.00 |
Reversibility*) |
- |
c. |
c. |
c. |
- |
Average time (unit) for reversion |
48 h |
96 h |
96 h |
- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these test conditions, 2-methyl-3-butenenitrile is slightly irritating. However, no classification is required according to EU criteria.
- Executive summary:
In an eye irritation study performed similarly to the OECD test guideline No. 405, 0.1 mL of undiluted 2 -methyl-3 -butenenitrile (2M3BN) was instilled into the conjunctival sac of left eye of 4 New Zealand White rabbits. The eyes of the animals were not rinsed after instillation. The right eye of each rabbit served as control. Changes were observed at 1, 24, 48, 72, 96 and 168 hours after dosing and grading according to Draize scale.
2M3BN produced chemosis (mean score 0.5),conjunctival redness (mean score 0.5), and iridial lesions (mean scores 0.33). All these effects were completely reversed after 4 days. No corneal lesions (mean score 0.0) were observed.
Under the test conditions, 2M3BN is slightly irritating to eyes but no classification is required according to the EU legislation (Directive 67/548/EEC and Regulation 1272/2008/EC).
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