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Description of key information

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:
28-07 to 31-07-1998
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4470 (Acute Dermal Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace animals, Boyertown, PA on 7/7/1998
- Quarantine period of at least one week.
- Age at study initiation: 2 to 4 months
- Weight at study initiation: 2.2 - 2.5 kg
- Fasting period before study: not applied
- Housing: 1/cage
- Diet (e.g. ad libitum): Fresh Purina Rat Chow (Diet #5321)
- Water (e.g. ad libitum): Tap water
- Acclimation period: 1 to 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
At 30 and 60 minutes after removal and cleaning, therafter at 24, 48 and 72 h.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Day prior to application of the test article, dorsal area of 10 x 15 cm of each animal was clipped free of hair.
- Coverage: four layer surgical gauze patch 2.5 x 2.5 cm
- Type of wrap if used: plastic wrap with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle with destilled water
- Time after start of exposure: 4 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0 - 72 h
Score:
0.44
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0 - 72 h
Score:
0.28
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0.83
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Other effects:
At 1 hour grade 1 erythema was observed in 2 animals, and grade 2 erythema was observed in 1 animal. Grade 1 edema was observed in 1 animal at this time point.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not classified as skin irritation (for Category 2 at least 4 out of 6 rabbits should show a mean score per animal of ≥ 2.3 ≤ 4.0 for erythema/eschar or for edema).
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:
28-07-1999 to 31-07-1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to international guidelines.
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
3/3 rabbit eyes washed after 30 seconds
6/6 rabbit eyex unwashed for 72 h
Observation period (in vivo):
1, 24, 48, 72 h
Number of animals or in vitro replicates:
9
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #1, 2, 4, 5 and 6
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #1, 2, 4, 5 and 6
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Time point:
other: 48-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
animal #3
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
(discharge)
Basis:
animal #3
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Unwashed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #7
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Washed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #7
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Irritation parameter:
chemosis score
Basis:
animal: #7
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Washed eyes
Irritation parameter:
chemosis score
Basis:
animal: #7
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #8
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Washed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #8
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness + discharge)
Basis:
animal: #9
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #9
Time point:
other: 24-48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: Washed eyes
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #9
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Irritation parameter:
chemosis score
Basis:
animal: #9
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Irritation parameter:
chemosis score
Remarks:
+ discharge
Basis:
animal: #9
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: Washed eyes
Other effects:
No other effects observed, systemic observations were normal.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not classified as an eye irritant since scores for irritation parameters were below 2 after 24 h following exposure.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Key study.

Justification for selection of eye irritation endpoint:
Key study.

Justification for classification or non-classification

The substance is not classified as skin or eye irritation.