Registration Dossier

Administrative data

Description of key information

The skin irritation gave mean erythema scores for both animals (24, 48 and 72 hours) were 0.7 -1, and a mean edema score for both animals (24, 48 and 72 hours) was 0. The test substance is not classified as a skin irritant according to EU CLP. In the eye irritation test the mean conjuctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48 and 72 hours) The test substance is not classified as an eye irritant according to EU CLP.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(partly limited documentation, e.g. no analytical characterisation of the test substance)
Principles of method if other than guideline:
Standardized test method (BASF-Test): The test substance was applied to a 2.5 x 2.5 cm application site of two white Vienna rabbits for 20 h under occlusive conditions. The skin was intact and shaved. After the application time, the skin was washed with water containing a mild detergent. Animals were observed for 5 or 6 days. Findings were recorded after 24, 48 and (for one animal) after 72 hours and at the end of the observation period. Descriptive scores of the raw data have been converted to Draize numerical scores, as recommended by the current OECD 404 Guideline.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS

Source: Gaukler
Weight at study initiation: 2.86 kg (mean)
Diet: ad libitum
Water: ad libitum
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of same animal
Amount / concentration applied:
1 mL
Duration of treatment / exposure:
The test substance was applied for 1 min, 5 min, 15 min and 20 h
Observation period:
5 or 6 days
Number of animals:
2 animals
Details on study design:
TEST SITE

Area of exposure: 2.5 cm x 2.5 cm
Type of wrap if used: occlusive


REMOVAL OF TEST SUBSTANCE

Washing: yes, with water containing a mild detergent (Lutrol)
Time after start of exposure: 1 min, 5 min, 15 min, 20 h


SCORING SYSTEM: Draize scoring system, as recommended by the OECD Testing Guideline 404
Irritation parameter:
erythema score
Remarks:
(20 h exposure)
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
(20 h exposure)
Basis:
animal #2
Time point:
other: mean over 24 and 48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
edema score
Remarks:
(20 h exposure)
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no edema observed
Irritation parameter:
edema score
Remarks:
(20 h exposure)
Basis:
animal #2
Time point:
other: mean over 24 and 48 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no edema observed
Irritant / corrosive response data:
Treatment 20 hours: Very slight signs of irritation (erythema score 1) were observed at the 24 and 48 hour reading time point in both animals. Effects were reversible within 72 hours in animal #1, whereas 72 hours reading time point is missing in animal #2. None of the animals displayed oedema.

Treatment 1 min / 5 min / 15 min: no erythema or edema observed until the end of the observation period (48 and 72 hours, respectively).

Mean erythema score animal #1 / animal #2 after 24, 48 and 72 h (72 h reading time point is missing in animal #2)

Exposure duration

24 h

48 h

72 h

Effect reversible after

20 h

1/1

1/1

0/-

72 h / 5 d

 

Mean score, animal #1 (24 – 48 – 72 h): 0.7

Mean score, animal #2 (24 – 48 h): 1

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean erythema scores for both animals (24, 48 and 72 hours) were 0.7 -1, and the mean edema score for both animals (24, 48 and 72 hours) was 0. The test substance is not classified as a skin irritant according to EU CLP.
Executive summary:

The skin irritation potential of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 404. 1 mL (g) of the test substance was applied in an occlusive cover to the clipped skin of Vienna white rabbits. The mean erythema scores for both animals (24, 48 and 72 hours) were 0.7 -1, and the mean edema score for both animals (24, 48 and 72 hours) was 0. The test substance is not classified as a skin irritant according to the EU Classification, Labelling and Packaging (CLP) criteria.

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:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(no details about the test substance; 50 µl instead of 100 µl test substance instilled, eyes were not washed out.)
Principles of method if other than guideline:
Standardized test method (BASF-Test): 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed after 10 min, 1 and 3 h on the day of treatment and up to 8 days afterwards. Findings were recorded daily. The eyes were not washed out after 24 hours as specified in OECD Guideline 405.
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: 2.05 kg (mean)
Diet: ad libitum
Water: ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as control treated with NaCl.
Amount / concentration applied:
TEST MATERIAL

Amount(s) applied (volume or weight with unit): 50 µL
Duration of treatment / exposure:
Single application (not washed out)
Observation period (in vivo):
72 h (study was interrupted after 72 h due to reversibility of observed effects)
Number of animals or in vitro replicates:
2 animals
Details on study design:
SCORING SYSTEM: Draize scoring system, as recommended by the OECD Testing Guideline 405

TOOL USED TO ASSESS SCORE: fluorescein (at the end of exposure period)
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: mean over 24, 48 and 72 h
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no effects observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal #1 and #2)
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: no effects observed
Other effects:
No other findings were observed.

Findings animal #1 / #2:

 Time

Redness

10 min

1 / 1

1 h

1 / 1

3 h

1 / 1

24 h

1 / 1

48 h

1 / 1

72 h

0 / 0

Mean (24 – 48 – 72 h)

0.7 / 0.7

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean conjuctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48 and 72 hours) The test substance is not classified as an eye irritant according to EU CLP.
Executive summary:

The eye irritation potential of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 405. 50 µl of the test substance was applied in a single application with the adjacent eye acting as a control treated with NaCl. The mean conjuctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48 and 72 hours) The test substance is not classified as an eye irritant according to EU CLP.

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

Additional information

The skin irritation potential of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 404. 1 mL (g) of the test substance was applied in an occlusive cover to the clipped skin of Vienna white rabbits. The mean erythema scores for both animals (24, 48 and 72 hours) were 0.7 -1, and the mean edema score for both animals (24, 48 and 72 hours) was 0. The test substance is not classified as a skin irritant according to EU CLP.

The eye irritation potential of the test substance was determined in accordance with the OECD Guideline for Testing of Chemicals 404. 50 µL of the test substance was applied in a single application with the adjacent eye acting as a control treated with NaCl. The mean conjuctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48 and 72 hours) The test substance is not classified as an eye irritant according to EU CLP.


Justification for selection of skin irritation / corrosion endpoint:
Study was conducted on the registered substance according to OECD Testing Guideline 404.

Justification for selection of eye irritation endpoint:
Study was conducted on the registered substance according to OECD Testing Guideline 405.

Justification for classification or non-classification

The skin irritation gave mean erythema scores for both animals (24, 48 and 72 hours) were 0.7 -1, and a mean edema score for both animals (24, 48 and 72 hours) was 0. The test substance is not classified as a skin irritant according to EU CLP. In the eye irritation test the mean conjuctivae score was 0.7, the mean cornea score was 0, the mean iris score was 0 and the mean chemosis score was 0 (all at 24, 48 and 72 hours) The test substance is not classified as an eye irritant according to EU CLP.