Registration Dossier
Registration Dossier
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EC number: 432-840-2 | CAS number: 220926-97-6
Endpoint summary
Administrative data
Description of key information
In a dermal irritation study with E96095 conducted according to OECD guideline No 404 in compliance with GLP, mean individual scores were 0.00/0.00/0.33 for erythema and 0.00 for oedema. Thus, E96095 is not classified as irritating to the skin according to the CLP Regulation (1272/2008).
In an eye irritation study with E96095 conducted according to the OECD Guideline No 405 and in compliance with GLP, mean individual scores were 0.0 for conjunctival redness, chemosis, corneal and iridial lesions. Thus, E96095 is not classified as irritating to eyes according to the CLP Regulation (1272/2008).
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)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- Sign of toxicity or ill health was not observed in any rabbit during the observation period.
Reference
Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal of the test
Score at time point / Reversibility |
Erythema Max. score: 4 |
Edema Max. score: 4 |
60 min |
0/0/2 |
0/0/1 |
24 h |
0/0/1 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.0/0.0/0.33 |
0.0/0.0/0.0 |
Reversibility |
C |
- |
Average time for reversion |
Within 48 hours |
|
C = completely reversible
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)
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- low value recorded for humidity (28 %)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- humidity value
- Principles of method if other than guideline:
- Not applicable
- Species:
- rabbit
- Strain:
- New Zealand White
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- individual score for each animal
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- individual score for each animal
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- individual score for each animal
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- individual score for each animal
- Time point:
- other: overall 24-48-72 h
- Score:
- 0
- Max. score:
- 3
- Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Reference
Table 7.3.2/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea Max. score 4 |
Iris Max. score 2 |
Conjunctivae Max. score 3 |
Chemosis Max. score 4 |
60 min |
0/0/0 |
0/0/0 |
2/1/1 |
0/0/0 |
24 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0.0/0.0/0.0 |
0.0/0.0/0.0 |
0.0/0.0/0.0 |
0.0/0.0/0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a dermal irritation study conducted according to OECD guideline No 404 and in compliance with GLP, three healthy adult rabbits were exposed to 0.5 g of E96095 at one skin site on the back, covered with a semi-occlusive dressing held in place for 4 hours. Mean individual scores (within 24, 48 and 72 h) were 0.00/0.00/0.33 for erythema and 0.00 for oedema.
In an eye irritation study conducted according to the OECD guideline No 405 and in compliance with GLP, three healthy adult rabbits were exposed to 0.1 mL of undiluted E96095. Mean individual scores (within 24, 48 and 72 h) were 0.0 for conjunctival redness, chemosis, corneal and iridial lesions.
Justification for selection of skin irritation / corrosion endpoint:
Study performed according to the OECD guideline 404 and GLP compliant
Justification for selection of eye irritation endpoint:
Study performed according to the OECD guideline 405 and GLP compliant
Justification for classification or non-classification
As no signs of irritation were observed in a dermal irritation study with E 96095 conducted according to OECD guideline No 404 in compliance with GLP, E96095 is not classified as irritating to the skin according to the CLP Regulation (1272/2008).
As no signs of irritation were observed in an eye irritation study with E96095 conducted according to the OECD guideline No 405 and in compliance with GLP, E96095 is not classified as irritating to eyes according to the CLP Regulation (1272/2008).
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