Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
1999
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

Constituent 1
Chemical structure
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

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.