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Diss Factsheets

Administrative data

Description of key information

Both for the Skin and Eye Irritation Endpoint in vivo studies were performed.

For Skin Irritation, a valid Guideline Study is available and for Eye Irritation a valid Guideline Study is available too.

In both Studies no adverse effects were observed.

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:
2007-03-06 - 2007-07-17 (experimental interval)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Study according to OECD / EU-Guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Nomcort HKG
- Substance type: organic
- Physical state: solid
- Analytical purity: 100%
- Lot/batch No.: 5-11-B
- Expiration date of the lot/batch: 29-APR-2007
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: at room temperature, light protected
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan NetherlandsBV, Kreuzelweg 53, NL-5961 NM Horst, The Netherlands
- Age at study initiation: 13 weeks (male), 14 weeks (female)
- Weight at study initiation: 1975 - 2231 g
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
Test item moistened with purified water.
Controls:
not required
Amount / concentration applied:
500 mg Test Item in 0.5 ml water
Duration of treatment / exposure:
4
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm * 2.5 cm
- Type of wrap if used: gauze, then semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM: as cited in Guidelines
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Skin Irritation Scores - individual values
Animal 1 (male)
Erythma (1 hour) 0
Erythma (24 hour) 0
Erythma (48 hour) 0
Erythma (72 hour) 0
Edema (1 hour) 0
Edema (24 hour) 0
Edema (48 hour) 0
Edema (72 hour) 0

Animal 2 (female)
Erythma (1 hour) 0
Erythma (24 hour) 0
Erythma (48 hour) 0
Erythma (72 hour) 0
Edema (1 hour) 0
Edema (24 hour) 0
Edema (48 hour) 0
Edema (72 hour) 0

Animal 3 (female)
Erythma (1 hour) 0
Erythma (24 hour) 0
Erythma (48 hour) 0
Erythma (72 hour) 0
Edema (1 hour) 0
Edema (24 hour) 0
Edema (48 hour) 0
Edema (72 hour) 0
Other effects:
no other effects reported
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, Nomcort HKG is considered to be "not irritating".
Executive summary:

The primary skin irritation potential of Nomcort HKG was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing.

The test item did not licit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

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:
2007-03-013 - 2007-05-02 (experimental interval)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Study according to OECD Guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Directive 2004/73/EC, B.5
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 2300-2536 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
no rinsing of test item was done
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to the numerical scoring system listed in Commission Directive 2005/73/EC

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 78 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days
Other effects:
Mortality and Clinical Signs: No clinical signs of systemic toxicity and no mortailty occurred. Irritation: No abnormal findings were observed in the treated eye of any animal after 48 hours treatment. However, after 1 hour instillation slight reddening of the conjunctivae, sclerae and slight swelling (chemosis) of the conjunctivae was observed in 3 animals. Reddening of the conjunctivae persisted in 1 animal at 24 hour Coloration: White remnants of the test item were observed in the eye at the 1-hour reading. Corrosion: No corrosion of the cornea was observed at any of the reading times.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, Nomcort HK-G is not irritating to the eye
Executive summary:

The primary eye irriation potential of Nomcort HKG was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item instillation. The mean score was caldulated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, sparately. The individual mean scores for corneal opacity and iris were 0.0 for all three animals. The individual mean scores for the conjunctivaed were 0.33, 0.00 and 0.00 for reddening, respectively and 0.00 for chemosis in all animals.

The instillation of Nomcort HKG into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 48 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. White test item remnants was present in two animals at the 1 hour reading.

No clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the rabbit eye.

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 valid study available

Justification for selection of eye irritation endpoint:

Only one valid study available

Justification for classification or non-classification

As no effects were observed in the performed studies and no other information are available concerning classification, the substance is not classified.