Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin irritation
Six rabbits were dermally exposed to the substance under occlusion for 24 hours. Observations at 24, 48 and 72 hours, as well after 7 days after exposure did not show any signs of irritation.
Eye irritation
The substance (0.1 mL) was applied to one eye of 9 rabbits. The eye of 3 of these rabbits was washed after application. No signs of irritation except for slight discharge and some very slight redness were observed. The effects were fully reversible after 48 hours in all animals. The substance is not irritating to the eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Existing in-vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 12 to 19, 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study similar to the guideline and under GLP. Only the results of the test on intact skin were taken into account.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Principles of method if other than guideline:
- 6 rabbits were treated on abraded and intact skin (each 2 sites per animal) during 24 hours
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Hill Farm, S. Brunswick NJ
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet: Pel1eted Purina Rabbit Chow (ad libitum)
- Water: tap water (ad libitum)
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-27 °C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data - 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 at each site
- Concentration: 90% formulation
VEHICLE: none - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 2 males and 4 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2 per application site
- % coverage: 10%
- Type of wrap if used: adhesive-backed gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none, gently wiped clean
- Time after start of exposure: 24 hour after application
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72 hours
- Score:
- >= 0 - <= 0.16
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Only the results of the intact skin were taken into account.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not irritating to the skin
- Executive summary:
Six rabbits were dermally exposed to the substance under occlusion for 24 hours. Observations at 24, 48 and 72 hours, as well after 7 days after exposure did not show any signs of irritation. Only the results of intact skin sites were taken into account. The substance is considered not irritating to the skin.
Reference
|
24 hours |
48 hours |
72 hours |
7 days |
||||
|
oedema |
erythema |
oedema |
erythema |
oedema |
erythema |
oedema |
erythema |
Animal 1 |
0/0* |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Animal 2 |
0/0 |
0/1 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Animal 3 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Animal 4 |
0/0 |
0/1 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Animal 5 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Animal 6 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
*site 1/site 2 of intact skin
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- Existing in-vivo study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 11 to 14, 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to the guideline and under GLP
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- 9 animals used
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet: Pelleted Purina Rabbit Chow(ad libitum):
- Water: tap water (ad libitum):
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-22 °C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): as such - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 9 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3/9 rabbits
- Time after start of exposure: 30-60 seconds after instillation
SCORING SYSTEM: Draize with special attention to unusual effects, such as pannus, blistering of the conjunctivae, ulceration and other indicators of corrosive action. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- unwashed
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- washed
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- unwashed
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- washed
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- unwashed
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- washed
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- unwashed
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- washed
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- dischage
- Basis:
- mean
- Remarks:
- unwashed
- Time point:
- other: 24-72 h
- Score:
- 0.05
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- washed
- Time point:
- other: 24-72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Other effects:
- none reported
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not an eye irritant
- Executive summary:
The substance (0.1 mL) was applied to one eye of 9 rabbits. The eye of 3 of these rabbits was washed after application. No signs of irritation except for slight discharge and some very slight redness were observed. The effects were fully reversible after 48 hours in all animals. The substance is not irritating to the eyes.
Reference
Animal no |
1 |
2 |
3 |
|||||||||
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
|
cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
-redness |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
-chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
-discharge |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
Animal no |
4 |
5 |
6 |
|||||||||
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
|
cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
-redness |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
-chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
-discharge |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
Animal no |
7 |
eyewash |
8 |
eyewash |
9 |
eyewash |
||||||
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
|
cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
-redness |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
-chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
-discharge |
2 |
1 |
0 |
0 |
2 |
2 |
0 |
0 |
1 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
study similar to the guideline under GLP
Justification for selection of eye irritation endpoint:
guideline study under GLP
Justification for classification or non-classification
Based on the available data the substance does not need to be classified for skin and/or eye irritation according to the criteria of CLP (Regulation EC No 1272/2008).
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.
