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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Updated version, adopted on 17 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Dated 31 July 1992
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Donor C20
IUPAC Name:
Donor C20
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2240-2530g
- Housing: individually housed in stainless cages with perforated floor
- Diet (e.g. ad libitum): standard laboratory rabbit diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-3°C
- Humidity (%): 60-70%
- Air changes (per hr): ca. 10 air changes/hour
- Photoperiod (hrs dark / hrs light):12 hours dark, 12 hours light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25 mL
Duration of treatment / exposure:
4 hours
Observation period:
Up to 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: back and flank of each animal
- % coverage: not reported
- Type of wrap if used: self adhesive gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleaned with moistened tissue
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1h, 24h, 48h, 72h.

SCORING SYSTEM:
- Method of calculation: Draize et al (1944)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects seen
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Time point:
24/48/72 h
Score:
0
Reversibility:
other:
Remarks:
no effects seen
Irritation parameter:
edema score
Time point:
24/48/72 h
Score:
0
Reversibility:
other:
Remarks:
no effects
Irritant / corrosive response data:
No oedema or erythema seen on any of the animals at the observation time points.
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No irritation was seen throughout the duration of the study where the test substance had been applied to the skin.