Registration Dossier
Registration Dossier
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EC number: 609-765-0 | CAS number: 39987-85-4
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:
- other information
- Study period:
- Dec 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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:
- 39987-86-5
- EC Number:
- 609-766-6
- Cas Number:
- 39987-86-5
- IUPAC Name:
- 39987-86-5
- Reference substance name:
- M-DOC
- IUPAC Name:
- M-DOC
- Reference substance name:
- 21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione
- IUPAC Name:
- 21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
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):
- 7 days
- Number of animals or in vitro replicates:
- 2 males and 2 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- reddening
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 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 | 0 | 0 | 0.3 | |
Conjunctiva (swelling) |
0 | 0 | 0 | 0.0 | |
2 (M) |
Cornea |
0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 1 | 0 | 0 | 0.3 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
3 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 1 | 0 | 0 | 0.3 | |
| Conjunctiva (reddening) | 2 | 1 | 0 | 1.0 | |
| Conjunctiva (swelling) | 2 | 0 | 0 | 0.7 | |
4 (F) |
Cornea | 0 | 0 | 0 | 0.0 |
| Iris | 0 | 0 | 0 | 0.0 | |
| Conjunctiva (reddening) | 1 | 0 | 0 | 0.3 | |
| Conjunctiva (swelling) | 0 | 0 | 0 | 0.0 | |
The control eyes were without findings.
The single application of 0.1 ml ZK 9340 (corresponding to 56.1- 62.9 mg) into the conjunctival sac of the right eye led on the application day to slight to moderate secretion, reddening of the outer eyelids and eyelid closure, one animal showing slight swelling of the outer eyelids. Slight to severe reddening and swelling of the conjunctivae was observed in all animals. Additionally, slight to moderate, in one animal severe, vascular injection was observed on the application day. Two animals showed very slight to slight reddening and slight blood vessel injection of the iris on day 1, one animal showed slight reddening of the iris until day 2. On days 2 and 3, very slight to moderate reddening and vascular injection of the conjunctivae was observed in all animals, one animal showed severe vascular injection and one showed slight swelling of the conjunctivae on day 2. These findings gradually faded away, and all animals were without findings 72 hours after application.
Applicant's summary and conclusion
- 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 on the whole moderate irritation on the day of treatment which gradually faded away over several days after application. 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, 0.1 for iris, 0.2 for conjunctival swelling as well as 0.5 for conjunctival reddening. According to EU classification criteria ZK 9340 need not be labelled as an eye irritant.
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