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Diss Factsheets

Administrative data

Description of key information

The test substance was found to be not irritating or corrosive to the skin and 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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik, D-88397 Biberach
- Weight at study initiation: 2670-2810g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag No.814, Gossau, Switzerland
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
moistened
Controls:
no
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 male rabbits
Details on study design:
An area of at least 36cm2 was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16cm2) bearing 0.5g of the test article was applied to the right flank of each animal. The skin area exposed directly to the test article was approx. 6 cm2. A control gauze patch was applied to the contralateral flank. Before application both patches were moistened with distilled water. The patches were loosely covered with an aluminum foil (approx. 36cm2) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg). The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
1.67
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hours
Score:
1
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0.66
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
4
Irritant / corrosive response data:
- Because of the red staining by the test article the evaluation of possible erythema reactions was impeded up to 72 hours after aplication in all animals. Therefore the mean values 24-72 hours for erythema reactios could not be calculated.
- Slight edema reactions were observed within 72 hours after removing the bandages.
- No signs of skin irritation was observed at the termination of the test on day 7.
Other effects:
- In 2 animals a slight loss of weight was observed on day 3 of the test.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.
Executive summary:

In a GLP compliant skin irritation study, performed according to OECD guideline 404, the test substance (moistened, 0.5g) was applied, semi-occlusive, to the skin of three New Zealand White rabbits for 4 hours. The erythema score could not be determined due to the red color of the test substance. However, after 7 days no erythema was observed. A edema score of 2, 1.67, 1, and 0.66 was observed at 1, 24, 48, 72 hours, respectively. Edema was fully reversible after 7 days. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.

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: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik, D-88397 Biberach
- Weight at study initiation: 2300-2450g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - Nafag No.814, Gossau, Switzerland
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
32 mg (equals 0.1mL in volume)
Duration of treatment / exposure:
Up to 7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
The test substance was placed into the conjunctival sac of the left eye of each animal after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The right eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of the test substance. In order to determine the reversibility of the eye reactions additional evaluations of the ocular reactions were needed in this study. A slit-lamp was used to facilitate the evaluation.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
0.66
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 and 72 hours and 7 days
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 and 24 hours
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 and 72 hours and 7 days
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 and 24 hours
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
1.33
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
1.67
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 and 72 hours
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
4
Other effects:
- One animal vocalised upon instillation.
- At the end of the observation period (day 7) the conjunctiva of all animals was slightly stained by the test article. This slight staining of the conjunctiva was considered not to represent any risk of serious damage to the eyes because of its minimal intensity and the fact that no functional relevant parts of the eye were involved. In the course of the physiological regeneration of the conjunctiva such a slight staining will most probably disappear without permanent lesions.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.
Executive summary:

In a GLP compliant eye irritation study, performed according to OECD guideline 405, the test substance (32mg) was placed in the conjunctival sac of the left eye of three New Zealand White rabbits. The eyes were examined for 7 days. A mean cornea score of 1 and 0.66 was observed at 1 hour and 24 hours, respectively. Iris scores observed were 1 at 1 and 24 hours. Chemosis scores were 2, 1.33, and 1 at up to 24, 48 and 72 hours, respectively. Chemosis scores observed were 2, 1.67, and 1 at 1, 24, and up to 72 hours, respectively. The scores observed at the other time points were 0. Although irritation was observed in the eye, this was completely reversible within 7 days. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

In a GLP compliant skin irritation study, performed according to OECD guideline 404, the test substance (moistened, 0.5g) was applied, semi-occlusive, to the skin of three New Zealand White rabbits for 4 hours (Ciba-Geigy 1994). The erythema score could not be determined due to the red color of the test substance. However, after 7 days no erythema was observed. A edema score of 2, 1.67, 1, and 0.66 was observed at 1, 24, 48, 72 hours, respectively. Edema was fully reversible after 7 days. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.

Eye irritation:

In a GLP compliant eye irritation study, performed according to OECD guideline 405, the test substance (32mg) was placed in the conjunctival sac of the left eye of three New Zealand White rabbits (Ciba-Geigy 1994). The eyes were examined for 7 days. A mean cornea score of 1 and 0.66 was observed at 1 hour and 24 hours, respectively. Iris scores observed were 1 at 1 and 24 hours. Chemosis scores were 2, 1.33, and 1 at up to 24, 48 and 72 hours, respectively. Chemosis scores observed were 2, 1.67, and 1 at 1, 24, and up to 72 hours, respectively. The scores observed at the other time points were 0. Although irritation was observed in the eye, this was completely reversible within 7 days. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.


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

Justification for selection of eye irritation endpoint:
Only study available

Justification for classification or non-classification

Based on the findings in the skin and eye irritation study the test substance does not need to be classified according to the Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008