Registration Dossier

Toxicological information

Eye irritation

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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:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dodecanedioic acid of Hüls AG, purity ca. 99 %;
impurities: homologous dicarboxylic acids, total 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..