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Diss Factsheets

Administrative data

Description of key information

Skin: OECD 404; practically non-irritating in rabbits. Reliability = 1
Eye: OECD 405; practically non-irritating in rabbits. Reliability = 1

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Substance ID: F6TF
Lot #: 8922/16
Purity: 99.7%
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adults
- Weight at study initiation: 2893-3429 g at the beginning of the study
- Housing: housed individually in cages suitable for animals of this strain
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15 changes/hour
- Photoperiod (hrs dark / hrs light): Artificial, giving 12 hours light, 12 hours dark

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL


Duration of treatment / exposure:
4 hours
Observation period:
1 hour and 1, 2, and 3 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: 4-ply surgical gauze with 2 strips of surgical tape covered with a piece of impermeable rubber sheeting wrapped with impermeable polyethylene tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes; clean swabs of absorbent cotton wool soaked in clean warm water and dried gently with clean tissue paper
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scale
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Very slight erythema was seen in one animal approximately 1 hour after washing. There were no signs of oedema in any animal and no additional signs of skin irritation.
Other effects:
There were no signs of ill-health in any animal during the study.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is practically a non-irritant to the skin.
Executive summary:

The study was conducted to assess the skin irritation potential of the test substance according to the guideline OECD 404 and EU method B.4. Three male rabbits were assessed for skin irritation. The test substance was applied undiluted and allowed to remain covered for 4 hours. The test sites were then washed and evaluated at 1 hour and 1, 2, and 3 days. Very slight erythema was seen in one animal approximately 1 hour after washing. There were no signs of oedema in any animal and no additional signs of skin irritation. The test substance was judged to be practically non-irritating in a single 4-hour application to rabbit skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

After application of a single 0.5 mL dermal dose to the shaved intact skin of rabbits for 4 hours, very slight erythema (score of 1) but no oedema was observed on the day of dosing. No dermal irritation was observed at 1, 2, or, 3 days after removal of the test substance.

After instillation of 0.1 mL of test substance into the lower conjunctival sac of the eye of 3 rabbits, slight conjunctival redness (score of 1) was observed in 1 rabbit at 1 day post-dosing, and slight discharge was observed in 1 rabbit 1 hour post-dosing. No corneal or iridial effects were observed. 


Justification for classification or non-classification:

The test substance produced transient very slight skin and eye irritation. The substance does not need to be classified for skin or eye irritation according the EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification