Registration Dossier
Registration Dossier
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EC number: 939-688-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25-JAN-2005 - 15-FEB-2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (29 April 2004)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (24 April 2002)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine, acetates (salts)
- EC Number:
- 939-688-0
- Molecular formula:
- Not applicable
- IUPAC Name:
- Fatty acids, C16-18 (even numbered), reaction products with tetraethylenepentamine, acetates (salts)
- Test material form:
- other: solid
- Details on test material:
- - Name of test material: Fatty acids, C16-18, reaction products with tetraethylenepentamine, acetates (salts)
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Fatty acids, C16-18, reaction products with tetraethylenepentamine, acetates (salts)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, F-69592 L’Arbresle
- Age at study initiation: 42 weeks (male), 11 weeks (females)
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 68/04) provided by Provimi Kliba
AG, CH-4303 Kaiseraugst
- Water (e.g. ad libitum): Community tap water from Fillinsdorf, ad libitum.
- Acclimation period: 6-7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- moistenes with 0.5 mL purified water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g/animal
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 4 cm x 4 cm on the flank
The patch was covered with a semi-occlusive. dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours, 7, 10 and 14 days
SCORING SYSTEM:
- Method of calculation: Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: scaling was observed from the 72 h observation, persisting up to day 10
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 d
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: scaling was observed from the 72 h observation, persisting up to day 10
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Score at time point |
3 min application |
1 h application |
||
Erythema |
Edema |
Erythema |
Edema |
|
0 h |
0 |
0 |
1 |
0 |
60 min |
0 |
0 |
1 |
0 |
24 h |
0 |
0 |
1 |
0 |
48 h |
0 |
0 |
1 |
0 |
72 h |
0 |
0 |
1 |
0 |
7 d |
0 |
0 |
0 |
0 |
10 d |
0 |
0 |
0 |
0 |
14 d |
0 |
0 |
0 |
0 |
Irritant/corrosive response data for each animal at each observation time (4 h treatment):
Score at time point |
Erythema |
Edema |
Scaling |
60 min |
2/2/2 |
2/2/2 |
0/0/0 |
24 h |
2/2/1 |
1/1/0 |
0/0/0 |
48 h |
2/1/1 |
1/1/0 |
0/0/0 |
72 h |
1/1/0 |
0/1/0 |
x/0/0 |
7 d |
0/1/0 |
0/0/0 |
x/0/0 |
10 d |
0/0/0 |
0/0/0 |
x/0/0 |
14 d |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24, 48, 72 h |
1.67/1.33/0.67 |
0.67/1/0 |
Not calculated |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study C16-18FA-TEPA-compound was not irritating to the skin.
- Executive summary:
In a primary dermal irritation study according to OECD guideline 404 (24 April 2002) and EU method B.4 (29 April 2004) 3 young adult New Zealand White rabbits were dermally exposed to 0.5 mg of C16-18FA-TEPA-compound (90% a.i.) for 4 hours. The substance was moistened with 0.5 mL purified water. Animals then were observed for 14 days. Irritation was scored by the method of Draize.
Very slight to well-defined erythema were observed from the 1- to the 48-hour reading in all animals and persisted as very slight erythema up to the 72-hour or 7-day examination in two animals, respectively. Slight edema was observed in all animals one hour after treatment and very slight edema persisted up to the 48- or 72-hour reading in two animals, respectively. Scaling was present at the application site of one animal from the 72-hour to the 10-day examination.
Mean erythema scores from observations at 24, 48 and 72 h after patch removal were 1.67/1.33/0.67; mean edema scores were 0.67/1/0.
In this study C16-18FA-TEPA-compound was not irritating to the skin.
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