Registration Dossier
Registration Dossier
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EC number: 211-746-3 | CAS number: 693-23-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-02-14 to 1989-05-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, individual data on conjuntival effects missing (last page of report, page 11, is missing)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Dodecanedioic acid
- EC Number:
- 211-746-3
- EC Name:
- Dodecanedioic acid
- Cas Number:
- 693-23-2
- Molecular formula:
- C12H22O4
- IUPAC Name:
- dodecanedioic acid
- Details on test material:
- Dodecanedioic acid of Hüls AG, purity ca. 99 %;
impurities: homologous dicarboxylic acids, total 1 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male
- Number of animals: 6 males
- Controls: untreated eye
- Weight at study initiation: 2.1-2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14.02 1989 To: 17.05.1989
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- ADMINISTRATION/EXPOSURE
- Concentration: undiluted
- Amount applied: 0.1 g
- Preparation of test substance: grinding in mortar
- Vehicle: none
- Postexposure observation period: 13 days - Duration of treatment / exposure:
- 72 hour(s)
- Observation period (in vivo):
- - Postexposure observation period: 13 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Comment: rinsed after 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6, 7, 8, 10 and 13 days after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.44
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 2.5
- Reversibility:
- fully reversible
- Remarks on result:
- other: erythema
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72h
- Score:
- 1.06
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.44
- Conjunctivae (Redness): 2.50
- Conjunctivae (Chemosis): 1.06
- Overall irritation score: 11.96/110 - Other effects:
- REVERSIBILITY: complete within 10 days
OTHER EFFECTS: There were no indications of mechanical irritation by the finely ground solid test material. Conglutination of eyelids was observed
in the males at 24 or at 48 hours.
Any other information on results incl. tables
no effects on cornea
Animal No |
Iris, Observation time |
||||
1 h |
24 h |
48 h |
72 h |
6-13 days |
|
57889 |
1 |
0 |
0 |
0 |
0 |
58051 |
1 |
0 |
0 |
0 |
0 |
58057 |
1 |
1 |
1 |
0 |
0 |
70115 |
1 |
1 |
0 |
0 |
0 |
70293 |
1 |
1 |
1 |
1 |
0 |
70327 |
1 |
1 |
1 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
- Conclusions:
- In this study, dodecanedioic acid was an eye irritant.
- Executive summary:
In a primary eye irritation study 0.1 g of dodecanedioic acid was instilled into the conjunctival sac of the right eye of six male young adult White Russian rabbits. Animals then were observed for 13 days.
Cornea were not affected. Iris was very mild and reversibly affected. Chemosis and erythema were recorded for conjunctival effects, mean score (24 -72h) was 2.5 for iridal redness. Eyes were normal with 1 - 7 days. In this study, dodecanedioic acid was an eye irritant..
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