Registration Dossier
Registration Dossier
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EC number: 947-785-4 | CAS number: -
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)
- Rationale for reliability incl. deficiencies:
- guideline study
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 (incl. QA statement)
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:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
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:
- GHS criteria not met
- Conclusions:
- The test article when administered to rabbits by dermal route, is to be considered non-irritant for the skin.
- Executive summary:
In an in vivo skin irritation/corrosion study according to OECD 404, three New Zealand White rabbits were exposed (occlusive patch) to the test substance fatty acids, tall oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine for a period of 4 hours. Skin readings for erythema and edema were performed 1 hour, 24 hours, 48 hours and 72 hours following exposure according to the Draize scoring system. A longer observation period was not required.
No general clinical signs were noted in any rabbit.
Locally, at the application sites, slight, transient dermal reactions were observed of grade 1/4 for erythema and edema, fully reversible within 24 hours and 48 hours in one animal.
Consequently, the test article, when administered to rabbits by dermal route, is to be considered "non-irritant" for the skin according to the GHS scoring system for classification.
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