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Registration Dossier
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EC number: 273-601-0 | CAS number: 68990-47-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 29, 1998 - January 1, 1999
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine
- EC Number:
- 273-601-0
- EC Name:
- Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine
- Cas Number:
- 68990-47-6
- Molecular formula:
- The substance is a UVCB substance. One of the most likely and the smallest molecule arising from the reaction process is assumed to be: C18H33O. C18H31O. 2C4H12N3 . C4H2O2
- IUPAC Name:
- Reaction product of 2,5-Furandione with reaction products of tall-oil fatty acids, diethylenetriamine, triethylenetetramine and tetraethylenepentamine
- Details on test material:
- Identification: Polyamide
CAS: No. 68990-47-6
Batch No.: CEM 2158/9
Characteristics: very viscous dark mass
Storage conditions: in a dark and cool place
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Conelli snc
- Age at study initiation: 2-3 mounth old
- Weight at study initiation: 2-3 kg
- Housing: the same room of treatment
- Diet : ad libitum)
- Water : from the municipal water main
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/-2 °C
- Humidity (%): 55% +/- 10
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 h circadian cycle
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.5 g/site
epidermal, single dose - Duration of treatment / exposure:
- Exposure times: 3 minutes, 1 hour and 4 hours.
- Observation period:
- Immediately and 72 hours after the 3 minute and the 1 hour exposure period in the first rabbit and at 1, 24, 48 and 72 hours after the 4 hours exposure period (all rabbits).
- Number of animals:
- 3 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hour
- Score:
- 0.34
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hour
- Score:
- 0.34
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
No changes were seen were the test article was applied for 3 minutes or 1 hour.
At the sites exposed for 4 hours erythema grade 1 was detected in all rabbits at the reading carried out 24 h from the end of exposure period.Erythema grade 1 was concomitantly observed in a single rabbit.
At the 48 hours reading very slight erythema still persistent in a single animal.
No dermal effects observed at the last reading (72 hours).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test article when administered to rabbits by dermal route, is to be considered NON IRRITANT for the skin.
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