Registration Dossier
Registration Dossier
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EC number: 247-666-0 | CAS number: 26401-97-8
Endpoint summary
Administrative data
Description of key information
Skin Irritation:
DOTI study: Under the conditions of the study the 24 and 72 hour PII for intact skin was 1.0 and 2.3, respectively. The combined (24 hour and 72 hour) average (PII) irritation score for intact skin was 1.6.
Study on read-across substance (DOTE) (CAS No 15571 -58 -1): Under the conditions of this study the test material is not irritating to the skin.
Eye Irritation:
DOTI study: Under the conditions of the study the test material was concluded not to be an eye irritant.
Study on read-across substance (DOTE) (CAS No 15571 -58 -1): Under the conditions of the study the test material was concluded not to be an eye irritant.
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:
- supporting study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: Draize
- Qualifier:
- according to guideline
- Guideline:
- other: Standard Methods of the Food and Drug Administration
- GLP compliance:
- no
- Remarks:
- This study pre-dates the inception of GLP.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 to 3 kg - Type of coverage:
- not specified
- Preparation of test site:
- other: abraded and non-abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 animals
- Details on study design:
- TEST SITE
- The backs of six rabbits were shaved 24 hours prior to the start of the experiment. A small cross-hatched abrasion was made on the right side of the animal. 0.5 mL of the test material was applied to the abraded area and an equal amount was placed on a non-abraded area.
- Type of wrap if used: the treatment area was covered with a gauze bandage and the animal restrained for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 24 hours the patches were removed and the treated areas were washed with water.
OBSERVATION TIME POINTS
- Readings were made according to the Draize method scale at 24 and 72 hours. - Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- (intact skin)
- Basis:
- mean
- Time point:
- other: 24/72 h
- Score:
- 1.6
- Reversibility:
- not specified
- Irritant / corrosive response data:
- - At 24 hours the test material caused erythema and oedema of varying degrees on both abraded and intact skin, although the reaction of abraded skin was slightly more intense. The average score at 24 hours for abraded skin was 1.5; for intact skin, 1.
- At 72 hours erythema and oedema had increased in both abraded and intact skin. Again, abraded skin had the more intense reaction. The average readings at 72 hours for abraded skin was 3.5; for intact skin, 2.3. The average score for 24 and 72 hours for abraded skin was 2.5; the average score for 24 and 72 hours for intact skin was 1.6; the combined average was 2.05, supporting data are given in Table 1. - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of the study the 24 and 72 hour PII for intact skin was 1.0 and 2.3, respectively. The combined (24 hour and 72 hour) average (PII) irritation score for intact skin was 1.6.
- Executive summary:
The skin irritation potential of the test material was investigated in a study broadly similar to OECD 404 using New Zealand White rabbits.
Animals were treated with 0.5 mL of test material on an abraded and non-abraded section of skin on their backs. The application was kept on the animals for 24 hours before removal and washing with water. The readings of erythema and oedema were made according to the Draize scale at 24 and 72 hours.
At 24 hours the test material caused erythema and oedema of varying degrees on both abraded and intact skin, although the reaction of abraded skin was slightly more intense. The average score at 24 hours for abraded skin was 1.5; for intact skin, 1. At 72 hours erythema and oedema had increased in both abraded and intact skin. Again, abraded skin had the more intense reaction. The average readings at 72 hours for abraded skin was 3.5; for intact skin, 2.3. The average score for 24 and 72 hours for abraded skin was 2.5; the average score for 24 and 72 hours for intact skin was 1.6.
Under the conditions of the study the 24 and 72 hour PII for intact skin was 1.0 and 2.3, respectively. The combined (24 hour and 72 hour) average (PII) irritation score for intact skin was 1.6.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 June 1996 to 23 June 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- other: read-across target
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:no data
- Age at study initiation:no data
- Weight at study initiation: 2615-3446 g
- Housing:individually
- Diet (e.g. ad libitum): not precised, ad libitum
- Water (e.g. ad libitum): not precised, ad libitum
- Acclimation period:for a minimum of six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 +/- 3
- Humidity (%):30-70%
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light):12-h light/dark period. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted, 0.5 mL on a 6.5 cm² area (1 x 1 inch).
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 12 days
- Number of animals:
- Four males and two females
- Details on study design:
- On the day to dosing, the hair was removed from the backs and flanks of the rabbits using an Oster small animal clipper. Each 0.5 mL dose was applied to an area of skin approximately 6.5 cm² under a secured two-ply gauze patch that was overwrapped with a gauze binder and secured with Dermiform tape. Plaxtic restraint collars were applied and remained on the animals for the duration of the exposure period. Each animal received a single, four-hour, semi-occluded exposure. At the end of four ours, the collars and bandages were removed and the sites wiped with disposable paper towels moistened with deionized water. The application sites were observed for erythema, edema and other dermal findings approximately 30-60 minutes and 24, 48 and 72 hours after patch removal and once daily through day 11 if irritation persisted. Skin reactions were evaluated according to the OECD scoring system and the irritant/corrosive potency of the test material was classified according to EC Directive 83/467/EEC.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Remarks on result:
- other: Mean individual scores : 3-2-2-2-1.67-2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Mean individual scores : 1-0-0.33-0-0.33-0.33
- Irritant / corrosive response data:
- Six and four rabbits had slight to moderate erythema and very slight edema, respectively. Desquamation was noted for three animals. Edema completely subsided by day 6 or earlier. There were no other dermal findings. All irritation was reversible and completely subsided by day 11 or earlier. Desquamation was noted for three animals. Edema completely subsided by day 6 or earlier. All irritation was reversible and completely subsided by day 11 or earlier. The test material received a descriptive rating classification of moderately irritating.
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study the test material is not irritating to the skin.
- Executive summary:
A GLP OECD Guideline 404 (Acute Dermal Irritation / Corrosion) test was carried out with the test material.
The test material was applied undiluted on a patch on shaved rabbit skin. The test material induced slight to moderate erythema on all rabbits and very slight edema on four animals. Three rabbits had desquamation. There were no other dermal findings. All irritation was reversible and completely subsided by day 11 or earlier.
The test material was moderately irritant but it was not classified under the experimental conditions. Under the conditions of this study the test material is not irritating to the skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- Read-across to structurally similar substance Dioctyltin bis (2-ethylhexylmercaptoacetate) (DOTE) (CAS No. 15571-58-1), see attached justification.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Remarks on result:
- other: Mean individual scores : 3-2-2-2-1.67-2
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Mean individual scores : 1-0-0.33-0-0.33-0.33
Referenceopen allclose all
Table 1: Results of Skin Irritation Study on the test material.
Time of reading |
Animal number |
Abraded skin |
Intact skin |
||
Oedema |
Erythema |
Oedema |
Erythema |
||
24 hours |
B36 |
0 |
1 |
0 |
0 |
B37 |
0 |
1 |
0 |
1 |
|
B38 |
0 |
1 |
0 |
1 |
|
B39 |
1 |
1 |
0 |
1 |
|
B40 |
1 |
1 |
0 |
1 |
|
B41 |
1 |
1 |
1 |
1 |
|
72 hours |
B36 |
0 |
1 |
0 |
0 |
B37 |
2 |
2 |
1 |
2 |
|
B38 |
1 |
3 |
1 |
2 |
|
B39 |
1 |
3 |
1 |
3 |
|
B40 |
2 |
2 |
1 |
1 |
|
B41 |
2 |
2 |
1 |
1 |
|
Average scores |
2.5 |
1.6 |
|||
Combined average: 2.05 |
|||||
Primary dermal irritation study in albino rabbits Individual dermal scores |
|||||||||||
0,5 ml/site |
|||||||||||
|
|
|
Erythema |
|
Edema |
||||||
Animal |
Sex |
Site |
0.5-1h |
24h |
48h |
72h |
Site |
0.5-1h |
24h |
48h |
72h |
20850 |
M |
A |
2 |
3 |
3 |
3 |
A |
0 |
1 |
1 |
1 |
20856 |
M |
A |
1 |
2 |
2 |
2 |
A |
0 |
0 |
0 |
0 |
20873 |
M |
A |
0 |
2 |
2 |
2 |
A |
0 |
0 |
0 |
1 |
20877 |
M |
A |
1 |
2 |
2 |
2 |
A |
0 |
0 |
0 |
0 |
20899 |
F |
A |
1 |
1 |
2 |
2 |
A |
0 |
0 |
0 |
1 |
20914 |
F |
A |
2 |
2 |
2 |
2 |
A |
0 |
0 |
0 |
1 |
|
|
Total |
7 |
12 |
13 |
13 |
Total |
0 |
1 |
1 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
h = hours; M = Male; F = Female |
|||||||||||
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
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- This study pre-dates the inception of GLP.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 to 3 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- The eye was held closed for 10 seconds
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- SCORING SYSTEM: Readings were made according to the Draize method at 24, 48 and 72 hours.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. At 48 hours ne animal had a slight redness.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. At 48 hours ne animal had a slight redness.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- - At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. The average irritation score at 24 hours was 2.
- At 48 hours one animal had a slight redness; no discharge or chemosis was noted at this time, The 48 hour average score was 0.3.
- At 72 hours there was no indication of irritation remaining. There was no trace of corneal damage, irial damage, or conjunctival irritation. The 72 hour score was 0.0 Supporting data are given in Table 1. - Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of the study the test material was concluded not to be an eye irritant.
- Executive summary:
The eye irritation potential of the test material was investigated in a study broadly similar to OECD 405 using New Zealand White rabbits.
Animals were treated with 0.1 mL of test material placed into their right eye, the eye was held closed for ten seconds and then the animal was returned to its cage. The readings were made according to the Draize scale at 24, 48 and 72 hours.
At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. The average irritation score at 24 hours was 2. At 48 hours one animal had a slight redness; no discharge or chemosis was noted at this time, The 48 hour average score was 0.3. At 72 hours there was no indication of irritation remaining. There was no trace of corneal damage, irial damage, or conjunctival irritation. The 72 hour score was 0.0.
Under the conditions of the study the test material was concluded not to be an eye irritant.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 30 May 1996 to 09 October 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Reason / purpose for cross-reference:
- other: read-across target
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA Health Effects Test Guidelines, 40 CFR 798.4500
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
Sex: males and females
Body weights: 2828 and 4148 g at initiation of dosing.
Housing: individual suspended mesh-bottom cages.
Acclimitisation: minimum of six days.
Diet: Purina certified rabbit chow #5322 and municipal water ad libitum.
ENVIRONMENTAL CONDITIONS
Room temperature: 66.5 and 68.2 °F
Relative humidity: 49.0-69.9 %.
Photoperiod: 12 hours light/12 hours dark - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- undiluted amount applied: 0.1 mL
- Duration of treatment / exposure:
- 96 hour(s)
- Observation period (in vivo):
- 4 days.
Animals observed twice daily for mortality.
Both eyes of the rabbits were examined for occular abnormalities prior to initiation of dosing, including the use of sodium fluorescein and UV light for detection of corneal abnormalities. Both eyes were examined macroscopically for ocular irritation using a hand-held penlight in accordance with the method of Draize. - Number of animals or in vitro replicates:
- 3/sex
- Details on study design:
- Eyes were not rinsed; the test material was placed directly into the cupped lower conjunctival sac of the right eye.
Body weight recorded on day 0 and at termination. - Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: All mean individual scores were 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- area
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: All mean individual scores were 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: All mean individual scores were 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean individual scores : 0.67-0.67-0.33-1.33-0-0
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean individual scores : 0-0.33-0-1-0-0
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: All mean individual scores were 0
- Irritant / corrosive response data:
- None of the rabbits vocalised upon installation of the test material.
The left (control) eyes were free of evidence of ocular irritation and other findings for the duration of the study.
There were no test material related deaths, clinical findings, or body weight changes during the study period. The maximum average score for diocytltin bis (2 -ethylhexylmercaproacetate was 8.0 at one hour post instillation. Positive conjunctival irritation was noted for 4/6 rabbits. All animals had minor conjunctival irritation. There were no iridal or corneal findings. All irritation was reversible and completely subsided by day 4. - Other effects:
- One female (no. 21091) lost 390g (14%) of initial (day 0) bodyweight. this weight loss was not considered to be related to test material administration. There were no other remarkable changes or differences observed in body weights during the study period.
- Interpretation of results:
- other: Not classified in accordance with EU Criteria
- Conclusions:
- Under the conditions of this study, the test material was not irritating to the eye.
- Executive summary:
The preliminary ocular irritation potential of the test material was evaluated in accordance with OECD 405, under GLP conditions using New Zealand White Rabbits.
Single 0.1 mL doses of the test material were instilled inot the lower conjuctival sac of the right eye of 6 albino rabbits. The eyelids were held closed for approximately 1 second and released. Left eyes were manipulated in a similar manner as the right eyes and served as contralateral controls. The eyes of all animals remained unwashed.
The eyes were examined for ocular reactions in accordance with the method of Draize at approximately 1, 24, 48, and 72 hours after dosing and on day 4 if irritation persisted. Sodium fluorescein was used to aid in revealing possible corneal damage at 24, 48, and 72 hours and on day 4. Postive conjunctival reactions were noted in the treated eye of 4 animals while minor conjuctival irritation was noted for all rabbits. There were no corneal or iridal findings. All irritation was reversible and completely subsided by day 4 or earlier.
Under the conditions of this study, the test material was not irritating to the eye.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- Read-across to structurally similar substance Dioctyltin bis (2-ethylhexylmercaptoacetate) (DOTE) (CAS No. 15571-58-1), see attached justification.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: All mean individual scores were 0
- Irritation parameter:
- cornea opacity score
- Remarks:
- area
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: All mean individual scores were 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: All mean individual scores were 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean individual scores : 0.67-0.67-0.33-1.33-0-0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean individual scores : 0-0.33-0-1-0-0
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: All mean individual scores were 0
Referenceopen allclose all
Table 1: Results of eye irritation study on the test material
Time of reading |
Animal number |
Cornea |
Iris |
Conjunctivae |
|||
Opacity |
Area |
Redness |
Discharge |
Chemosis |
|||
24 hours |
B62 |
0 |
0 |
0 |
2 |
1 |
0 |
B63 |
0 |
0 |
0 |
1 |
0 |
0 |
|
B64 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B65 |
0 |
0 |
0 |
1 |
0 |
0 |
|
B66 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B67 |
0 |
0 |
0 |
1 |
0 |
0 |
|
24 h average score |
2 |
||||||
48 hours |
B62 |
0 |
0 |
0 |
1 |
0 |
0 |
B63 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B64 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B65 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B66 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B67 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 h average score |
0.33 |
||||||
72 hours |
B62 |
0 |
0 |
0 |
0 |
0 |
0 |
B63 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B64 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B65 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B66 |
0 |
0 |
0 |
0 |
0 |
0 |
|
B67 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 h average score |
0 |
||||||
Table 1. Individual ocular irritation scores for conjuctiva.
| Animal/sex | 1h (R-C-D) | 24h (R-C-D) | 48h (R-C-D) | 72h (R-C-D) | 4d (R-C-D) |
| 1 m | 2 -1 -1 | 1 -0 -0 | 1 -0 -0 | 0 -0 -0 | |
| 2 m | 2 -1 -1 | 1 -1 -0 | 1 -0 -0 | 0 -0 -0 | |
| 3 m | 1 -1 -1 | 1 -0 -0 | 0 -0 -0 | 0 -0 -0 | |
| 4 f | 2 -1 -2 | 2 -1 -0 | 1 -1 -0 | 1 -1 -0 | 0 -0 -0 |
| 5 f | 1 -1 -2 | 0 -0 -0 | 0 -0 -0 | 0 -0 -0 | |
| 6 f | 2 -1 -1 | 0 -0 -0 | 0 -0 -0 | 0 -0 -0 | |
R-redness
C-chemosis
D-discharge
m-male
f-female
Table 2. Individual body weights (g).
| Animal number | Sex | Initation (day 0) | Termination (interval) |
| 21044 | m | 2841 | 2898 (day 3) |
| 21049 | m | 3159 | 3286 (day 3) |
| 21055 | m | 2876 | 3027 (day 3) |
| 20638 | f | 4148 | 4120 (day 4) |
| 21072 | f | 3088 | 3125 (day 3) |
| 21091 | f | 2828 | 2438 (day 3) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation - DOTI study
The skin irritation potential of the test material was investigated in a study broadly similar to OECD 404 using New Zealand White rabbits.
Animals were treated with 0.5 mL of test material on an abraded and non-abraded section of skin on their backs. The application was kept on the animals for 24 hours before removal and washing with water. The readings of erythema and oedema were made according to the Draize scale at 24 and 72 hours.
At 24 hours the test material caused erythema and oedema of varying degrees on both abraded and intact skin, although the reaction of abraded skin was slightly more intense. The average score at 24 hours for abraded skin was 1.5; for intact skin, 1. At 72 hours erythema and oedema had increased in both abraded and intact skin. Again, abraded skin had the more intense reaction. The average readings at 72 hours for abraded skin was 3.5; for intact skin, 2.3. The average score for 24 and 72 hours for abraded skin was 2.5; the average score for 24 and 72 hours for intact skin was 1.6.
Under the conditions of the study the 24 and 72 hour PII for intact skin was 1.0 and 2.3, respectively. The combined (24 hour and 72 hour) average (PII) irritation score for intact skin was 1.6.
Skin Irritation: Read-across to structurally similar substance (DOTE) (CAS No 15571 -58 -1).
A GLP OECD Guideline 404 (Acute Dermal Irritation / Corrosion) test was carried out with the test material.
The test material was applied undiluted on a patch on shaved rabbit skin. The test material induced slight to moderate erythema on all rabbits and very slight edema on four animals. Three rabbits had desquamation. There were no other dermal findings. All irritation was reversible and completely subsided by day 11 or earlier.
The test material was moderately irritant but it was not classified under the experimental conditions. Under the conditions of this study the test material is not irritating to the skin.
Eye Irritation - DOTI study
The eye irritation potential of the test material was investigated in a study broadly similar to OECD 405 using New Zealand White rabbits. The study was awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch et al. (1997).
Animals were treated with 0.1 mL of test material placed into their right eye, the eye was held closed for ten seconds and then the animal was returned to its cage. The readings were made according to the Draize scale at 24, 48 and 72 hours.
At 24 hours the test material caused slight redness in four out of six animals, and a slight discharge in one. The average irritation score at 24 hours was 2. At 48 hours one animal had a slight redness; no discharge or chemosis was noted at this time, The 48 hour average score was 0.3. At 72 hours there was no indication of irritation remaining. There was no trace of corneal damage, irial damage, or conjunctival irritation. The 72 hour score was 0.0.
Under the conditions of the study the test material was concluded not to be an eye irritant.
Eye Irritation: Read-across to structurally similar substance (DOTE) (CAS No 15571 -58 -1).
The preliminary ocular irritation potential of the test material was evaluated in accordance with OECD 405, under GLP conditions using New Zealand White Rabbits.
Single 0.1 mL doses of the test material were instilled inot the lower conjuctival sac of the right eye of 6 albino rabbits. The eyelids were held closed for approximately 1 second and released. Left eyes were manipulated in a similar manner as the right eyes and served as contralateral controls. The eyes of all animals remained unwashed.
The eyes were examined for ocular reactions in accordance with the method of Draize at approximately 1, 24, 48, and 72 hours after dosing and on day 4 if irritation persisted. Sodium fluorescein was used to aid in revealing possible corneal damage at 24, 48, and 72 hours and on day 4. Postive conjunctival reactions were noted in the treated eye of 4 animals while minor conjuctival irritation was noted for all rabbits. There were no corneal or iridal findings. All irritation was reversible and completely subsided by day 4 or earlier.
Under the conditions of this study, the test material was not irritating to the eye.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the test material does not require classification in regards to skin or eye irritation.
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