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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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.