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Diss Factsheets

Administrative data

Description of key information

Skin irritation / rabbit_ Evaluation of Acute Dermal Irritation/Corrosion of ACN in Albino Rabbits_ 20.12.2005_Report n°KBL/2005/1516 HR

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 Nov - 20 Dec 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS -air conditioned
- Temperature (°C): 18 - 21°C
- Humidity (%): 30 - 55%
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: 0.5 % (m/v) solution of Tylose MH 1000 in deionised water
Controls:
other: Approximately 24 hours before testing the fur on the backs of the animals was closely clipped over an area of approximately 4 x 5 cm on the left and right side of the spine. One area was used as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
Animal 1: 3 min, 1 and 4 h
Animals 2 and 3: 4 h
Observation period:
1, 24 48 and 72 h after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: ca. 6 cm2
- Type of wrap if used: gaze patch

REMOVAL OF TEST SUBSTANCE
- Washing: cleaned with deionised water without altering the integrity of the epidermis
- Time after start of exposure: 4h
Irritation parameter:
erythema score
Basis:
animal: #1, 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Not any skin irritation was observed at any observation time after all exposure periods.
Other effects:
No further local or systemic effects were noted.

Animal No: Exposureperiod Observed grades of skin alterations at each observation time
Erythema hours after administration Oedema hours after administration
1 24 48 72 1 24 48 72
1 3 min 1 0 0 0 0 0 0 0
1h 1 0 0 0 0 0 0 0
4h 0 0 0 0 0 0 0 0
Control 0 0 0 0 0 0 0 0
2 4h 0 0 0 0 0 0 0 0
Control 0 0 0 0 0 0 0 0
3 4h 0 0 0 0 0 0 0 0
Control 0 0 0 0 0 0 0 0
Interpretation of results:
GHS criteria not met
Conclusions:
In accordance with the results of this study and in accordance with the criteria of Regulation /EC) 1272/2008, the product may be classified as a substance that is non-irritant to the skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification