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EC number: 203-965-8 | CAS number: 112-38-9
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-03-23 till 1999-04-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Undec-10-enoic acid
- EC Number:
- 203-965-8
- EC Name:
- Undec-10-enoic acid
- Cas Number:
- 112-38-9
- Molecular formula:
- C11H20O2
- IUPAC Name:
- undec-10-enoic acid
- Details on test material:
- - Physical state: Colorless solid
- Analytical purity: 99.5%
- Storage condition of test material: in dark at RT
- batch 9807016 filling 41/99
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- all males
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- a single administration
- Observation period (in vivo):
- 1h, 24h, 48h, 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 11
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 9
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Remarks:
- day 13
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 5
- Remarks:
- within day 5
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 5
- Remarks:
- within day 5
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 10
- Remarks:
- day 10
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8, days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 9
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: Day 15
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea (opacity) |
Iris |
Conjunctivae (Redness) |
Chemosis |
Conjunctivae (Discharge) |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
0/2/2 |
3/3/3 |
2/2/2 |
24 h |
2/1/1 |
1/0/1 |
2/2/2 |
3/2/3 |
S/2//2 |
48 h |
2/1/1 |
1/0/1 |
2/2/2 |
3/2/3 |
S/1/1 |
72 h |
1/1/1 |
1/1/1 |
2/1/1 |
3/2/2 |
0/0/1 |
Average 24h, 48h, 72h |
1.7/1/1 |
1/0.3/1 |
2/1.7/1.7 |
3/2/2.7 |
0.7/1/1.3 |
Reversibility*) |
c/c/c |
c/c/c |
c/c/c |
c/c/c |
c/c/c |
Average time (days) for reversion |
6.7 |
4.7 |
7.3 |
9.7 |
3.7 |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
s= whitish purulent discharge
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- According to CLP (regulation EC, No 1272-2008), the test substance Acide Undecylenique is to be classified as "Eye IrritantCategory 2 (irritating to eyes)"
- Executive summary:
The potential of the test substance ACIDE UNDECYLENIQUE to induce ocular irritation was evaluated in rabbits according to OECD guideline No. 405/ and EU directive 92/69/EEC B.5. 0.1 g Acide Undecylenique was placed in the conjunctival sac of the left eye of three male New Zealand White rabbits. Animals were observed for 15 days. Eye irritation was scored and mean values for chemosis, redness of conjunktiva, iris lesions and corneal opacity were calculated. Very slight to moderate conjunctival reactions were observed in all animals from day 1; these reactions persisted up to day 14 at the latest. A slight iritis was noted in two animals at day 2, it persisted up to day 4 or 10, respectively. A very slight or slight corneal opacity was recorded in all animals on day 2; it persisted up to day 4 (two animals) or 12. Under the experimental conditions, the test substance ACIDE UNDECYLENIQUE is irritant when administered by ocular route to rabbits.
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