Registration Dossier
Registration Dossier
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EC number: 942-166-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
two in vivo studies targeting skin and eye irritation available.
No signs of irritation/corrosion were noted in these studies.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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: well performed Guideline Study under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute 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: Yonam College of Agricultur
- Age at study initiation: 17 weeks
- Weight at study initiation: 2.04 - 2.37 kg
- Housing: individual
- Diet: purina experimental diet for rabbits ad libitum
- Water: filtered and sterilized Drinking water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 - 21.6
- Humidity (%): 42.2 - 64.1
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL / site - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: patch, silk techs surgical tape and soft cloth tape with liner
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: as described in Guideline - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: over all observation time points
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No signs of irritation (erythema and edema) where observed in any animal at any time point
- Other effects:
- no other effects
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No signs of irritation/corrosion were observed in this study. Therefore Nomcort SG was not a skin irritant under the conditions of this study.
- Executive summary:
This study was conducted to evaluate the effects on skin irritation of the test substance, Nomort SG, in 17 weeks old male NZW (Yac:NZW (KBL)) rabbits.
As a result, in 1, 24, 48 and 72 hours after the patch removal, there was no skin irritation in all animals for the initial and confirmatory tests. Primary skin irritation index was recorded as 0. In conclusion it was evaluated as "non irritant" in accordance with Draize's method.
Abnormal clinical signs and body weight changes by the test substance were not observed in all animals during the observation period.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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: OECD Guideline Study under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Yonam College of Agriculture
- Age at study initiation: 17 weeks
- Weight at study initiation: 2.00 - 2.17 kg
- Housing: individual
- Diet: purina experimental diet for rabbit, ad libitum
- Water: filtered and sterilized drining water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 - 21.6
- Humidity (%): 42.2 - 64.1
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- preparation: The substance was ground to a fine powder - Duration of treatment / exposure:
- no washing after instillation was performed
- Observation period (in vivo):
- 1 hour, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
not performed
SCORING SYSTEM: according to Draize method, eye irritation range by Kay and Calandra method.
TOOL USED TO ASSESS SCORE: not stated - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- other: Opacity and Area score taken together
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animal #2, #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- other: animal #2, #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- other: animal #2, #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.16
- Max. score:
- 110
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- see table above
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was not considered as an irritant. The slight effects were interpreted as mechanical irritation caused by the physical shape of the test item.
- Executive summary:
This study was designed to examine the eye irritation effects of Nomcort SG. The test substance in 100% was administered to three healthy male New Zealand White (Yac:NZW(KBL)) rabbits.
In the initial test, 0.1 g of the test substance was administered to the conjunctival sac of the right eye in one animal. In 24 hours, mild irritant effect was observed, so the confirmatory test was conducted using two additional animals. The eye irritation of the test substance was calculated according to the Draize's method; and eye irritation range was classified by the method of Kay and Calandra.
As a result, 1 hour after the administration, score 1 for conjunctival redness, chemosis and discharge were observed. After 24 hours, score 1 for conjunctival redness (3 animals) and score 1 for discharge (1 animal) were observed. However, it was recovered to normal at 48 hours after the administration.
Abnormal clinical signs and body weight changes by the test substance were not observed in all animals during the observation period.
Reference
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:
Only one study available. This study is considered reliable to meet
the information requirements for this endpoint.
Justification for selection of eye irritation endpoint:
Only one study available. This study is considered reliable to meet
the information requirements for this endpoint.
Justification for classification or non-classification
The presented information is conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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