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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
2004-11-03 to 2004-11-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across to hydrolysis product.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
24 April 2002
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Directive 92/69/EEC
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:Ferenc Sándor breeder, 2173 Kartal, Vörös Hadsereg Street 131, HUNGARY
- Age at study initiation: young adult rabbits 10 weeks old
- Weight at study initiation: 2513-2764 g
- Housing: Animals were housed individually in metal cages.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 8-12
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5mL
- Concentration (if solution): 100 %

Duration of treatment / exposure:
4 hours
Observation period:
Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes, and then at 24, 48, 72 hours after the patch removal.
Number of animals:
3 male animals
Details on study design:
TEST SITE
- Area of exposure: 6 %.
- Type of wrap if used: plastic.

REMOVAL OF TEST SUBSTANCE
- Washing: Remaining test item was removed with water at body temperature.
- Time after start of exposure: 4 hours.

SCORING SYSTEM:
- The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 404, 2002).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No response observed.
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test item 2,2-Dimethyl-3-lauroyloxy-propanal applied to the rabbits’ skin evoked no observable irritating response. Thus, the classification of the test item as a skin irritant is not required.
Executive summary:

The acute skin irritation study of 2,2-Dimethyl-3-lauroyloxy-propanal was performed in New Zealand White rabbits. The irritation effect of the test item was evaluated according to the Draize method (OECD No.: 404, 2002). The test item was administered in a pure state, as a single dose of 0.5 mL, to the shaved skin of all experimental rabbits. The untreated skin of each animal served as control. After 4 hours any remaining test item was removed with water at body temperature. The animals were examined at 1, 24, 48 and 72 hours after the patch removal. No irritation symptoms (erythema and oedema) or other signs occurred after the patch removal and during the 72-hour observation period, so the study was terminated at the 72nd hour. During the study the behaviour and general state of animals were normal. The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00 respectively. Thus, the classification of the test item 2,2-Dimethyl-3-lauroyloxy-propanal as a skin irritant is not required.