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Description of key information

Skin Effects


The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance or 0.5 mL of a dilution (10 % in sesame oil) for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. No erythema or edema were seen at any time point (score 0). The test item is not irritating under these test conditions.


Eye Effects


Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. Only slight effects could be observed (conjunctiva redness score of 1 in 3/6 animals after 7 and 24 h, which was fully reversible within 72 h). No other effects could be observed in any animal.

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: FDA guideline (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)
Deviations:
not specified
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Housing: individually
- Weight at study initiation: 1.5-2.0 kg
- Diet: mixed feed ERKA 8300 (Robert Koch, Hamm), ad libitum
- Water: tap water, ad libitum
Type of coverage:
occlusive
Preparation of test site:
other: clipped intact and clipped scarified
Vehicle:
other: seasame oil or undiluted
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml of 10 % dilution and 500 mg of undiluted substance
Duration of treatment / exposure:
24 h
Observation period:
48 h after end of exposure
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm gauze patch
- Type of wrap if used: PVC foil, elastic bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p.27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.

Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Remarks on result:
other: clipped intact and clipped scarified
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Remarks on result:
other: clipped intact and clipped scarified
Irritant / corrosive response data:
None of the animals showed oedema or erythema at the intact or scarified skin at any time point (immediately, 24 and 48 hours after end of exposure)
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is not irritating to skin under these test conditions.
This conclusion is legitimate even though the applied testing regime differs from today's standard methods. Since the test conditions were more stringent than required by OECD TG 404 (i.e. 24 h treatment, occlusive coverage, and scarified skin instead of 4 h treatment, semi-occlusive coverage, and intact skin) the test results are considered adequate to fulfill the endpoint requirements.
Executive summary:

The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 g test substance or 0.5 mL of a dilution (10 % in sesame oil) for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. No erythema or edema were seen at any time point (score 0). The test item is not irritating under these test conditions.

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: FDA guideline (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)
Deviations:
not specified
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: individually
- Weight at study initiation: 1.5-2.0 kg
- Diet: mixed feed ERKA 8300 (Robert Koch, Hamm), ad libitum
- Water: tap water, ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: basically in accordance with OECD TG 405.
Scores were read 1, 7, 24, 48 and 72 h after test substance application.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 48 and 72 h reading
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effect
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: #1, #5, #6 each
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Irritant / corrosive response data:
Iris, cornea and chemosis score were 0 for all six animals at all time points (1, 7, 24, 48 and 72 h after removal of the test item). A redness of the conjunctiva was observed at the 7 h -reading in animal #2, 3 and 4 (score1). It persisted up to 24 h (animal 2) and 48 h (animal 3 and 4) with a score of 1.
No discharge was observed in any animal at any time point.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is very slightly irritating to the eyes under the test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points. 3/6 animals showed a conjunctiva redness score of one, 7 and 24 h after application, the effect being fully reversible within 72 h. No other effects were observed.
The slight effect does not result in a classification of the test item according to the classification criteria of Regulation (EC) No 1272/2008.
Executive summary:

Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of six animals. The eyes were washed 24 h after application and eye responses were noted for 72 h after start of the exposure. Only slight effects could be observed (conjunctiva redness score of 1 in 3/6 animals after 7 and 24 h, which was fully reversible within 72 h). No other effects could be observed in any animal.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

No classification, as no adverse effects were observed.

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