Registration Dossier

Administrative data

Description of key information

Irritation/corrosion:
- skin: not irritating
- eye: irritating

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
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 h
Observation period:
1h, 1d, 2d, 3d, 7d
Number of animals:
4
Details on study design:

SCORING SYSTEM:
Irritation was assessed and allocated a numerical value based on the following:
- Erythema and Eschar Formation
No erythema = 0;
Very slight erythema (barely perceptible) = 1;
Well-defined erythema = 2;
Moderate to severe erythema = 3;
Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4.

- Oedema Formation:
No oedema = 0;
Very slight oedema (barely perceptible) = 1;
Slight oedema (edges of area well-defined by definite raising) = 2;
Moderate oedema (raised approximately 1 mm) = 3;
Severe oedema (raised more than 1 mm and extending beyond area of exposure) = 4.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: all animals
Time point:
24/48/72 h
Score:
0.92
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.11
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.08
Max. score:
1
Reversibility:
fully reversible within: 7 d
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was not qualified as irritating nor corrive according to the OECD TG 404.
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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles, not according to current guidelines
Reason / purpose:
reference to same study
Principles of method if other than guideline:
Internal BASF method was used
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male 3.19 kg, female 3.44 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: NaCl into other eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): 100%
Duration of treatment / exposure:
continuously
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM:
Gradings for corneal opacity, conjunctival redness and chemosis were converted into numerical grading system acc. to Draize.

Chemosis (Swelling) and cornea (Opacity):
0 = none
1 = slight
2 = well defined
3 = severe
4 = very severe


Conjunctival redness (Redness):
0 = normal
1 = slight
2 = well defined
3 = severe
4= very severe
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 72 h
Score:
1.25
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not specified for 48h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not specified for 48h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not specified for 48h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not specified for 48h

Animal 1: male

Animal 2: female

Results:

Readings Animal Erythema chemosis Corneal opacity Additional findings
1h 1 2 1 1 miosis
2 2 3 2 miosis
3 h 1 2 1 1 discharge
2 2 2 2 discharge
24 h 1 1 1 2 mucosal hemorrhages
2 2 1 2 mucosal hemorrhages
72 h 1 1 0 1 mucosal hemorrhages
2 1 0 3 mucosal hemorrhages, scar
4 d 1 1 0 1 mucosal hemorrhages
2 1 0 3 mucosal hemorrhages, scar
7 d 1 1 0 1  
2 1 0 1 scar
8 d 1 1 0 1  
2 1 0 1 scar
Mean 24 - 72 h 1 1 0.5 1.5  
2 1.5 0.5 2.5  
Mean   1.25 0.5 2

No effects reported for iris.

No effects observed for eyes treated with NaCl.

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In the study for eye irritation of the test item applied to eyes of two Vienna White rabbits, reactions were evaluated for eight days. As result, mean scores (24, 72 hours) for corneal opacity, conjunctival redness and chemosis were 1.5, 1 and 0.5, for animal 1 and 2.5, 1.5 and 0.5 for animal 2, respectively. Conjunctival redness and corneal opacity were not reversible within the eight day observation period. The test substance has been found to be irritating to eyes under the chosen testing conditions.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Justification for classification or non-classification

The present data on skin irritation do not fulfill the criteria laid down in CLP regulation, and therefore, the substance is not classified.

The present data on eye irritation fulfills the criteria laid down in CLP regulation.

Therefore, the substance can be classified as "irritating to eye" or "eye irritant" (category 2).