Registration Dossier

Administrative data

Description of key information

No skin reaction was noted both in a key study and a supplemental study.
Reversible eye irritation was noted.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-02-14 to 1989-02-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: small white russian
Details on test animals and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male
- Weight at study initiation: 2.2 - 2.4 kg
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
Concentration: 50 %
ADMINISTRATION/EXPOSURE 
- Preparation of test substance: 0.5 g ground in mortar, wetted with 0.5  ml deionized water
- Area of exposure: 6 cm2
- Occlusion: mull patch, elastic dressing - Removal of test substance: washing with warm water - Post exposure period: 6 days
Duration of treatment / exposure:
4 hour(s)
Observation period:
6 days
Number of animals:
3
Details on study design:
EXAMINATIONS
- Examination time points: 1, 24, 48, 72 hours, and 6 days after patch  removal; evaluation based on readings 1-4 - Scoring system: OECD Guideline; evaluation: VCI notes on safety data  sheet and Appendix VI of 79/831/EEC
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1h, 24h, 48h,72h, 6 days
Score:
0
Max. score:
0
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.0
- Edema: 0.0
REVERSIBILITY: not applicable
Other effects:
OTHER EFFECTS: No reaction was observed
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
Conclusions:
Classification: not irritating
Executive summary:

In a skin irritation study 0.5 g dodecanedioic acid, moistened with distilled water, was applied to the shaved skin of a group of three male rabbits for 4 hours. No skin irritation was observed.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
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
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
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.

    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

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..

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No skin irritation was noted in two studies in rabbits.

Reversible eye irritation was noted, namely average score for conjunctival erythema (24h-72h) was 2.5. Effects noted were reversible within 10 days.


Effects on eye irritation: irritating

Justification for classification or non-classification

According to the criteria of EC regulation 1272/2008 and based on the results of the studies the test item has to be classified as eye irritant (Cat. 2) and labelling required with Warning, H319: Causes serious eye irritation.