Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 211-746-3 | CAS number: 693-23-2
Endpoint summary
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
- 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
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: small white russian
- Details on test animals or test system 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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. - 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..
Reference
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 |
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
