Registration Dossier

Administrative data

Description of key information

The substance is not irritating to the skin and slightly irritating to the eye.

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:
other: OECD-Guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill ltd. Huntingdon, UK
- Housing: single cage
- Diet Ssniff K 4 ad libitum
- Water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 40 - 60 °C
- Photoperiod (hrs dark / hrs light): 12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg pasted with water
Duration of treatment / exposure:
4 hours
Observation period:
1 h, 24 h, 48 h, 72 h, 7 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm*2.5 cm
- Type of wrap if used: cellulose and elastic, adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing : with water
- Time after start of exposure: 4hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1h
Score:
ca. 0.33
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
4
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 d
Score:
0
Max. score:
4
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item did not show any signs of skin irritation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD-Guideline Study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Housing: single cages
- Diet: Ssniff K 4, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 40 - 60 %
- Photoperiod (hrs dark / hrs light): 12
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
substance with a volume of approx. 100 µl
Duration of treatment / exposure:
24 hours unwashed, then washing with physiological saline
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: optical devices / fluorescein
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
12.3
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
9.6
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
5
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
110
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test item is mildly irritant to the rabbits eye.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The in-vivo tests on the rabbit skin and eye are the standard tests for skin and eye irritation.

As the test data was available, no in-vitro tests were performed.


Justification for selection of skin irritation / corrosion endpoint:
Only one study available

Justification for selection of eye irritation endpoint:
Only one study available

Effects on eye irritation: slightly irritating

Justification for classification or non-classification