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EC number: 605-140-1 | CAS number: 158237-07-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Nov - 13 Dec 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Nov - 13 Dec 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24 February 1987
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation: adult
- Weight at study initiation: 3.9 kg, 4kg, 3.7 kg
- Housing: individual housed in stainless steel cages with flat rod bases or plastic cages with perforated bases, under standardized conventional conditions
- Diet: Standard diet (Ssniff K4, Ssniff Spezialdiaten GmbH,Soest), approx. 100 - 120 g per animal/day; once per day in the morning
- Water: tap water, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1.5
- Humidity (%): 20 - 60
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12/12
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 µl pulverized test substance, corresponding to approximately 31 mg
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48 and 72 h and 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the treated eye was rinsed with saline
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize scoring system, the aqueos humour (opacity) as described by Mc Donald and Shadduck
TOOL USED TO ASSESS SCORE: hand-slit lamp, fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- Only in one rabbit mild irritation (score 1) of the conjuctivae was observed at the 1 h reading time point. No further reactions have been observed in any animal., which was fully reversible within 48 h.
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- Under the conditions of the acute eye irritation/corrosion test, the test substance did not show irritant properties.
CLP: not classified
Table 2: Test for Irritant Effects on the Eye (Expos. 24 h, DRAIZE grade)
Animal number |
Tissue |
Sign |
1 h |
24 h |
48 h |
72 h |
7 day |
1 |
cornea |
opacity |
0 |
0 |
0 |
0 |
0 |
redness |
0 |
0 |
0 |
0 |
0 |
||
fluorescein |
intensity |
- |
0 |
- |
- |
- |
|
area |
- |
0 |
- |
- |
- |
||
iris |
|
0 |
0 |
0 |
0 |
0 |
|
conjunctivae |
redness |
1 |
1 |
0 |
0 |
0 |
|
swelling |
0 |
0 |
0 |
0 |
0 |
||
aqueous humour |
|
0 |
0 |
0 |
0 |
0 |
|
discharge |
|
0 |
0 |
0 |
0 |
0 |
|
2 |
cornea |
opacity
|
0 |
0 |
0 |
0 |
0 |
redness |
0 |
0 |
0 |
0 |
0 |
||
fluorescein |
intensity |
- |
0 |
- |
-- |
- |
|
area |
- |
0 |
- |
- |
- |
||
iris |
|
0 |
0 |
0 |
0 |
0 |
|
conjunctivae |
redness |
0 |
0 |
0 |
0 |
0 |
|
swelling |
0 |
0 |
0 |
0 |
0 |
||
aqueous humour |
|
0 |
0 |
0 |
0 |
0 |
|
discharge |
|
0 |
0 |
0 |
0 |
0 |
|
3 |
cornea |
opacity
|
0 |
0 |
0 |
0 |
0 |
redness |
0 |
0 |
0 |
0 |
0 |
||
fluorescein |
intensity |
- |
0 |
- |
- |
- |
|
area |
- |
0 |
- |
- |
- |
||
iris |
|
0 |
0 |
0 |
0 |
0 |
|
conjunctivae |
redness |
0 |
0 |
0 |
0 |
0 |
|
swelling |
0 |
0 |
0 |
0 |
0 |
||
aqueous humour |
|
0 |
0 |
0 |
0 |
0 |
|
discharge |
|
0 |
0 |
0 |
0 |
0 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 17 July 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-5-oxo-4,5-dihydro-1H-1,2,3,4-tetrazole-1-carboxamide
- EC Number:
- 605-140-1
- Cas Number:
- 158237-07-1
- Molecular formula:
- C16H20ClN5O2
- IUPAC Name:
- 4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-5-oxo-4,5-dihydro-1H-1,2,3,4-tetrazole-1-carboxamide
1
Test animals
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation: adult
- Weight at study initiation: 3.4 kg, 3.9 kg, 3.7 kg
- Housing: individual housed in stainless steel cages with flat rod bases or plastic cages with perforated bases, under standardized conventional conditions
- Diet: Standard diet (Ssniff K4, Ssniff Spezialdiaten GmbH,Soest), approx. 100 - 120 g per animal/day; once per day in the morning
- Water: tap water, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1.5
- Humidity (%): 20 - 60
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: ununchanged, pulverized test substance was applied moistened with deionized water
- Controls:
- not required
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 500 mg (pulverized test substance, moistened with deionized water)
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h and 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorso-lateral area of the trunk, 6 cm²
- Type of wrap if used: semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with water without altering the existing response, or the integrity of the epidermis.
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
1, 24, 48 and 72 h and 7 days
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No local reactions indicative for skin irritation have been observed except very slight erythema which have been observed 1 h after patch removal in one animal which was fully reversible within 24 h. No other skin reactions were determined.
Any other information on results incl. tables
Table 1; Test for Irritant Effects on the Skin (Expos.: 4 h, DRAIZE grade)
animal number |
1 h |
24 h |
48 h |
72 h |
7 day |
|||||
|
erythema |
oedema |
erythema |
oedema |
erythema |
oedema |
erythema |
oedema |
erythema |
oedema |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- A reliable study conducted in accordance with OECD 404 and GLP, determined the test material to be non- irritating to the skin of rabbits. Very slight erythema observed in one animal 1 h after patch removal were fully reversible within 24 h and no oedema were reported at any time point. CLP: not classified
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