Registration Dossier
Registration Dossier
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EC number: 442-490-2 | CAS number: 871-70-5 EMEROX 118
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Valid without restriction. Well documented GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- EPA Guideline 81-4
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,18-octadecanedioic acid
- EC Number:
- 442-490-2
- EC Name:
- 1,18-octadecanedioic acid
- Cas Number:
- 871-70-5
- Molecular formula:
- C18H34O4
- IUPAC Name:
- octadecanedioic acid
- Reference substance name:
- Octadecanedioic acid
- EC Number:
- 617-978-5
- IUPAC Name:
- Octadecanedioic acid
- Test material form:
- solid: flakes
- Details on test material:
- Purity: 100% active matter
Remarks: White, solid.
Solubility: Poorly soluble (=< 2 mg/L in test medium).
Carbon chain length distribution: C16 2,98%, C18 92,9%, C18:1 1,04%
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye was left untreated as a negative control.
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 1, 24, 48, 72, and 168 hrs.
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Time point:
- other: 6
- Other effects:
- No lesions observed
One hour after application, all six animals animal were positive for conjunctival symptoms and two animals showed iris effects. Maximum irritation effects
were seen at 24 hrs (group mean score 22.5/110) when corneal opacity was also observed in five animals.
After 168 hours, only one animal showed irritation effects. The scores for each animal at each reading, and the mean score for each animal are shown in the
tables below.
Any other information on results incl. tables
Group Mean Scores for Ocular Lesions (Draize values)
Rabbit No. |
|
1 hr. |
24 hrs. |
48 hrs. |
72 hrs. |
168 hrs. (7 days) |
611 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge
|
-- -- 0
2 2 2 |
1 2 1
2 2 3 |
0 0 0
2 1 1 |
0 0 0
2 1 1 |
0 0 0
0 0 0 |
612 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge
|
-- -- 0
2 2 2 |
1 1 0
2 2 3 |
0 0 0
2 1 1 |
0 0 0
1 1 1 |
0 0 0
0 0 0 |
613 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge
|
-- -- 1
2 2 2 |
1 3 1
2 2 3 |
1 1 0
2 1 1 |
0 0 0
1 1 1 |
0 0 0
0 0 0 |
614 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge
|
-- -- 0
2 1 1 |
1 1 0
2 1 2 |
0 0 0
1 0 0 |
0 0 0
1 0 0 |
0 0 0
0 0 0 |
615 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge
|
-- -- 0
1 1 1 |
0 0 0
2 1 1 |
0 0 0
1 0 0 |
0 0 0
1 0 0 |
0 0 0
0 0 0 |
616 |
Cornea opacity, degree Cornea opacity, area Iris Conjunctiva Redness Chemosis Discharge
|
-- -- 1
2 2 2 |
1 3 1
2 2 3 |
1 1 0
2 1 1 |
0 0 0
2 1 1 |
0 0 0
0 0 0 |
Group Mean Scores for Ocular Lesions (Draize values)
Average |
1 hr. |
24 hrs. |
48 hrs |
72 hrs. |
168 hrs |
Cornea |
-- |
8.3 |
1.7 |
0.0 |
0.0 |
Iris |
1.7 |
2.5 |
0.0 |
0.0 |
0.0 |
Conjunctiva |
10.3 |
11.7 |
5.0 |
4.7 |
0.0 |
Total |
12.0 |
22.5 |
6.7 |
4.7 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: other: OECD No. 405 (1987) and EPA Guideline 81-4
- Conclusions:
- EPA/OECD Toxicity Category III for eye effects – corneal involvement or irritation clearing in 7 days or less.
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