Registration Dossier
Registration Dossier
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EC number: 210-940-5 | CAS number: 626-27-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Aug to Sep 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - 4 instead of 3 animals
- GLP compliance:
- yes
Test material
- Reference substance name:
- Heptanoic anhydride
- EC Number:
- 210-940-5
- EC Name:
- Heptanoic anhydride
- Cas Number:
- 626-27-7
- Molecular formula:
- C14H26O3
- IUPAC Name:
- heptanoyl heptanoate
- Reference substance name:
- Heptanoic acid anhydride
- IUPAC Name:
- Heptanoic acid anhydride
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Weight at study initiation: 2.7-2.9 kg (males), 2.6 kg (females)
- Housing: 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >= 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22°C
- Humidity (%): 56-62 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- test substance remained in the eye (eye was not rinsed)
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 2 males and 2 females
- Details on study design:
- 0.1 mL correspond to ca. 93 mg test substance
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
Any other information on results incl. tables
Table 1: Results of the study
Irritant effects (score) |
|||||
Animal no. (sex) |
Irritation parameter |
24 h | 48 h | 72 h | Mean scores |
1 (M) |
Cornea |
0 | 0 | 0 | 0.0 |
Iris |
0 | 0 | 0 | 0.0 | |
Conjunctiva (reddening) |
1 | 1 | 1 | 1.0 | |
Conjunctiva (swelling) |
1 | 1 | 1 | 1.0 | |
2 (M) |
Cornea |
0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 1 | 1 | 1 | 1.0 | |
| Conjunctiva (swelling) | 1 | 1 | 1 | 1.0 | |
3 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 1 | 0 | 0 | 0.33 | |
| Conjunctiva (reddening) | 1 | 1 | 1 | 1.0 | |
| Conjunctiva (swelling) | 2 | 2 | 1 | 1.67 | |
4 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 1 | 1 | 1 | 1.0 | |
| Conjunctiva (swelling) | 1 | 1 | 1 | 1.0 | |
The control eyes were without findings.
The single application of 0.1 mL ZK 56406 into the conjunctival sac of the right eye led to slight to moderate reddening and swelling of the conjunctivae in most of the animals from administration day one up to day 6. In one female animal reddening was seen up to day 7 and in one male animal up to day 9, respectively. In one male and in one female animal swelling of the conjunctivae appeared up to day 7 of the test. Vessel injection of the iris was seen in one female animal 24 hours after instillation. All animals were without findings on day 10.
Applicant's summary and conclusion
- Interpretation of results:
- other: slight to moderate irritation (fully reversible by day 10)
- Executive summary:
In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight to moderate irritation on the day of administration which decreased in severity from day 2 onwards and were fully reversible on day 10 after administration. The mean values of findings relevant for classification at the time-points 24, 48 and 72 hours after application were 0 for the parameter cornea, 0.08 for iris, 1.17 for conjunctival swelling and 1.0 for conjunctival reddening. According to EU classification criteria ZK 56406 need not be labelled as an eye irritant.
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