Registration Dossier
Registration Dossier
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EC number: 952-655-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Tetradecyl myristate (CAS No 3234 -85 -3), a constituent of the registration substance, and Octyldodecyl isostearate (CAS No 93803 -87 -3), a structural analogue of the registration substance, were tested for their skin irritant properties in New Zealand White rabbits. The studies were performed according to OECD Guideline 404.With reference the reported scores and the full reversibility of effects it is concluded that the registration substance does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
An in vivo eye irritation study in rabbits was perfromed with tetradecyl myristate (CAS No. 3234 -85 -3), a constituent of the registration substance, 2 -Ethylhexyl laurate and 2-octyldodecyl isooctadecanoate (CAS No 93803 -87 -3),
structural analogues of the registration substance. The studies were conducted according to OECD Guideline 405.
With reference the reported scores and the reversibility the registration substance does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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:
- weight of evidence
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure period 24 h, occlusive conditions, no experimental 48 h reading performed, few details reported
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, the untreated site of the same animal served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
Reading time points: 24 and 72 h - Number of animals:
- 6 males
- Details on study design:
- SCORING SYSTEM: Draize scoring system
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Remarks on result:
- other: no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)
- Irritant / corrosive response data:
- Intact skin:
1/6 animals had slight erythema (score 1 of 4) at the 24-hour reading time point, which had cleared completely by the 72-hour reading time point (see Table 1). No other skin irritation effects were observed in any animals.
Abraded skin:
1/6 animals had slight erythema (score 1 of 4) at the 24-hour reading time point. The skin irritation had cleared within 48 hours. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- With reference the reported scores and the full reversibility of effects within 72 h the test item does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
Tetradecyl myristate (CAS No 3234 -85 -3), a constituent of the registration substance, was tested for its skin irritant properties in 6 New Zealand White rabbits. The study was performed according to OECD Guideline 404.
With reference the reported scores and the full reversibility of effects within 72 h the test item does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 17 - 20 Feb 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to cread across justification justification setcion 13.2
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to cread across justification justification setcion 13.2
4. DATA MATRIX
Please refer to cread across justification justification setcion 13.2 - Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- 3/3 animals had well-defined erythema at the 1-hr reading time point. The erythema had reduced in severity by 24 hours after exposure in 3/3 rabbits (score 1, 1, 1), and had cleared completely within 72 hours for 3/3 rabbits. No edema was observed in any animal at any time point (see Table 1).
- Other effects:
- There was no mortality, and no clinical signs were observed during the study period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- With reference the reported scores and the full reversibility of effects within 72 h the test item does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
Octyldodecyl isostearate (CAS No 93803 -87 -3), a structural analogue of the registration substance, was tested for its skin irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 404. With reference the reported scores and the full reversibility of effects within 72 h the test item does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Referenceopen allclose all
Table 1: individual erythema and edema scores for intact skin
Observation time |
Rabbit No. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
24 h |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
|
|||||||||||
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 2: calculation of mean scores for intact skin
|
Rabbit No. |
|||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
Mean value 24+48+72 h |
0 |
0 |
0.67 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 1: Skin irritation scores
Observation time |
Rabbit no. |
|||||||
|
1 |
2 |
3 |
|
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
||
1 h* |
2 |
0 |
2 |
0 |
2 |
0 |
|
|
24 h |
1 |
0 |
1 |
0 |
1 |
0 |
|
|
48 h |
1 |
0 |
0 |
0 |
0 |
0 |
|
|
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Mean value 24 + 48 + 72 h |
0.67 |
0 |
0.33 |
0 |
0.33 |
0 |
|
|
|
||||||||
* Greasy remnants of the test substance was present on the test site in 3/3 rabbits
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:
- supporting study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- ; purity not reported, 50% dilution of test substance
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.8-2.4 kg - Vehicle:
- other: corn oil
- Controls:
- other: the left eye served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 50% (w/w)
VEHICLE
- Concentration (if solution): 50% (w/w) - Duration of treatment / exposure:
- Single application without washing
- Observation period (in vivo):
- 7 days
Reading time points: 24, 48 and 72 h, and 7 days - Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed after instillation.
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-held lens - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of all 6 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 all 6 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:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- 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:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- Slight redness was observed in 4/6 animals at the 24-hour reading time point, which had cleared completely within 72 hours (see Table 1). No other eye irritation effects were observed in any of the animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- not irritating to the eyes
- Executive summary:
An in vivo eye irritation study in rabbits was perfromed with tetradecyl myristate (CAS No. 3234 -85 -3), a constituent of the registration substance. Mean scores for cornea, iris, conjunctiva redness and chemosis for all 6 animals after 24, 48, and 72 hours were 0, 0 and in the range of 0.33 to 0.66. All effects were fully reversible within 72 h. Thus, the substance does not have to be classified according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 23 - 26 Feb 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to cread across justification justification setcion 13.2
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to cread across justification justification setcion 13.2
4. DATA MATRIX
Please refer to cread across justification justification setcion 13.2 - Reason / purpose for cross-reference:
- read-across source
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 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:
- out of all 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:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- 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:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- At the 1-hour reading time point 3/3 rabbits had slight conjunctivae (score 1, 1, 1), which was still present in 1/3 rabbits at the 24-hour reading time point. The effect had cleared completely within 48 hours. No other eye irritation effects were observed in any rabbit at any time point (see Table 1).
- Other effects:
- There was no mortality, and no clinical signs were observed during the study period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- With reference the reported scores and the reversibility the test item does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
2-octyldodecyl isooctadecanoate (CAS No 93803 -87 -3), a strucutral analogue of the registration substance, was tested for its eye irritant properties in 3 Albino-Himalayan rabbits. The study was performed according to OECD Guideline 405.
Effects on conjunctivae were observed in only one animal after application. These signs were fully reversible within 48 hours..
With reference the reported scores and the reversibility the test item does not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 19 Dec - 21 Dec 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to cread across justification justification setcion 13.2
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to cread across justification justification setcion 13.2
4. DATA MATRIX
Please refer to cread across justification justification setcion 13.2 - Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 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:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no details reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- With reference the reported scores and reversibility of effects within 48 hours the test itemdoes not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification & Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
2 -Ethylhexyl laurate, a structural analogue of the registration substance, was tested for its eye irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 405.
Effects on conjunctivae were observed in one animal after application. These signs were fully reversible within 48 hours.
With reference the reported scores and reversibility of effects within 48 hours the test itemdoes not have to be classified as irritant to the eyes according to the criteria laid down in the EU Classification & Labelling and Packaging Regulation (1272/2008/EC).
Referenceopen allclose all
Table 1: Individual eye irritation scores
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
conjunctivae
|
iris
|
cornea
|
||
redness |
swelling |
redness |
swelling |
|||||||
1
|
|
|
|
|
|
|
||||
24 |
1 |
0 |
0 |
0 |
||||||
48 |
1 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.67 |
0.0 |
0.0 |
0.0 |
Time to reversion |
72.0 |
0.0 |
0.0 |
0.0 |
|
2
|
|
|
|
|
|
|
|
|||
24 |
1 |
0 |
0 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.33 |
0.0 |
0.0 |
0.0 |
Time to reversion |
48.0 |
0.0 |
0.0 |
0.0 |
|
3
|
|
|
|
|
|
|
|
|||
24 |
0 |
0 |
0 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.0 |
0.0 |
0.0 |
0.0 |
Time to reversion |
0.0 |
0.0 |
0.0 |
0.0 |
|
4
|
|
|
|
|
|
|
|
|||
24 |
1 |
0 |
0 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.33 |
0.0 |
0.0 |
0.0 |
Time to reversion |
48.0 |
0.0 |
0.0 |
0.0 |
|
5
|
|
|
|
|
|
|
|
|||
24 |
1 |
0 |
0 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.33 |
0.0 |
0.0 |
0.0 |
Time to reversion |
48.0 |
0.0 |
0.0 |
0.0 |
|
6
|
|
|
|
|
|
|
|
|||
24 |
0 |
0 |
0 |
0 |
||||||
48 |
0 |
0 |
0 |
0 |
||||||
72 |
0 |
0 |
0 |
0 |
||||||
average |
0.0 |
0.0 |
0.0 |
0.0 |
Time to reversion |
0.0 |
0.0 |
0.0 |
0.0 |
|
|
|
|||||||||
|
Time [h] |
conjunctivae
|
iris |
cornea |
||||||
|
redness |
swelling |
|
|
avg. time to reversion |
36.0 |
0.0 |
0.0 |
0.0 |
|
average score |
|
|
|
|
|
|
||||
24 |
0.67 |
0.00 |
0.00 |
0.00 |
||||||
48 |
0.17 |
0.00 |
0.00 |
0.00 |
||||||
72 |
0.00 |
0.00 |
0.00 |
0.00 |
||||||
24+48+72 |
0.28 |
0.00 |
0.00 |
0.00 |
||||||
Table 1: Eye irritation scores
Rabbit #
|
Time [h]
|
conjunctivae
|
iris
|
cornea
|
|
redness |
swelling |
||||
1
|
1 |
1 (AB) |
0 |
0 |
0 |
24 |
1 (A) |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.33 |
0.0 |
0.0 |
0.0 |
|
2
|
1 |
1 (ABC) |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.00 |
0.0 |
0.0 |
0.0 |
|
3
|
1 |
1 (AB) |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.00 |
0.0 |
0.0 |
0.0 |
|
|
Time [h] |
conjunctivae
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
average score |
1 |
1.00 |
0.00 |
0.00 |
0.00 |
24 |
0.33 |
0.00 |
0.00 |
0.00 |
|
48 |
0.00 |
0.00 |
0.00 |
0.00 |
|
72 |
0.00 |
0.00 |
0.00 |
0.00 |
|
24+48+72 |
0.11 |
0.00 |
0.00 |
0.00 |
|
A = eyelids
B = nictating membrane
C = sclera
Table 1: Results of eye irritation test
Rabbit No. / sex |
Scoring [h] |
Cornea |
Iris |
Conjunctiva |
1 / m |
1 |
0 |
0 |
1 |
|
24 |
0 |
0 |
1 |
|
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0.33 |
|
2 / m |
1 |
0 |
0 |
2 |
|
24 |
0 |
0 |
1 |
|
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0.33 |
|
3 / m |
1 |
0 |
0 |
2 |
|
24 |
0 |
0 |
1 |
|
48 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
|
7 days |
0 |
0 |
0 |
Mean (24, 48, 72 h) |
0 |
0 |
0.33 |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
With reference the reported scores and the full reversibility of effects it is concluded that the registration substance does not have to be classified neither as irritant to the skin nor as eye irritating according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
