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Description of key information

In order to assess the dermal irritation or corrosion potential of the test substance an OECD 404 study was performed. Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the skin.
In order to assess the eye irritation potential of the test substance an OECD 405 study was performed. Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant 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
Study period:
1984-10-02 to 1984-10-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Complete guideline conform study report available. Study is performed under GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: polyethyleneglycol 400
Controls:
not required
Amount / concentration applied:
500 mg test substance moistened with 1.2 mL 0.9 % polyethyleneglycol 400
Duration of treatment / exposure:
4 hours
Observation period:
30- 60 min., 24, 48 and 72 hours after treatment.
Number of animals:
3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the skin.
Executive summary:

In order to evaluate the dermal irritant/corrosive potential of the test substance an in vivo test in rabbits was performed in 1984 which was in accordance to guideline OECD 404. 24 hours prior to treatment the animals back was shaved to receive a skin area of about 10 x10 square centimeters for treatment. Only animals with intact skin were chosen for the test. The 3 animals were each treated with 0.5 mL test substance per animal on the right flank, whereas the left side serves as control. The treated area was covered by an semi-occlusive bandage and fixed with a non-irritant tape for 4 hours. After these 4 hours, the bandage was removed and the remaining test substance was carefully removed from the skin. Mortality and clinical signs of toxicity were observed once daily. The skin was assessed for edema, eschar formation or erythema according to Draize, 60 minutes, 24, 48 and 72 hours after removing of bandage. No mortality occurred. No clinical signs of toxicity were observed. The overall mean scoring value is 0 for erythema and edema formation.

Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the skin.

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
Study period:
1984-10-02 to 1984-10-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Complete guideline conform study report available. Study is performed under GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
other: 0.9 % polyethyleneglycol
Controls:
not required
Amount / concentration applied:
100 mg test substance moistened with 0.3 mL 0.9 % polyethyleneglycol
Duration of treatment / exposure:
24 hours after application of the test substance into the conjuctival sac of the left eye, the eyes were washed out with lukewarm physiological saline.
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hurs
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 48 hrs
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the eye.
Executive summary:

In order to assess the eye irritating potential of the test substance, 100 mg of the test item moistened with 0.3 mL of 0.9 % polyethyleneglycol was applied into the conjunctival sac of the left eye of each of 3 rabbits. The untreated eye served as control. After 24 hours the treated eye was washed. The assessment of possible effects to the eyes was performed with the assistance of a lamp 60 minutes, 24, 48 and 72 hours after application of test item. The eye reactions were assessed according to the numerical scoring system (acc. to Draize). The description of the degree and nature of irritation and the presence of serious damage were noted as follows:

- No mortality or signs of systemic toxicity occurred.

- Hyperemia was observed in all three animals at the one hour and 24 hour time point with a maximum score of 2. This effect was still observed in one animal with a score of 1 at the 48 hour time point (mean score 0.7 - 1 - 0.3). This effect was reversible within 72 hours.

- Chemosis of the conjunctiva was observed in two animals one hour (maximal score 2) and in one animal 24 hours after application (mean score 0 - 0.3 - 0). This effect was reversible within 48 hours.

- No corneal opacity were observed in all three animals 24, 48 and 72 hours after application of the test substance (mean score 0-0-0).

- No effects at Iris was observed in all animals 24, 48 and 72 hours after application of the test substance (mean score 0-0-0).

Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

As demonstrated with an OECD 404 study in rabbits the test substance registered has no skin irritating potential under the test conditions.

In order to evaluate the eye irritation potential of the test substance one OCED 405 study in rabbits is available. For the study 100mg mL of the test material moistend with 0.3 mL 0.9 % polyethyleneglycol was applied into one of each eye of three rabbits. The treated eyes were washed out 24 hours after application of the test item.The rabbits were observed for up to 72 hours to determine the grade of ocular reaction to the test material. All three tested animals had a slight positive reaction of hyperemia with the test material at the 24 hour timepoint after start of treatment. This effect was still observed in one animal 48 hours after treatment but was fully reversible within 72 hours. One of three animals had a slight chemosis 24 hours after treatment, which was fully reversible within 48 hours. Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the eye.


Justification for selection of skin irritation / corrosion endpoint:
A valid GLP compliant study is available which was performed in accordance to OECD 404.

Justification for selection of eye irritation endpoint:
A valid GLP compliant study is available which was performed in accordance to OECD 405.

Justification for classification or non-classification

Based on the available data no classification for skin irritation is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Based on the available data no classification for eye irritation is warranted according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

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