Registration Dossier
Registration Dossier
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EC number: 248-777-7 | CAS number: 28015-99-8
Endpoint summary
Administrative data
Description of key information
Skin irritation
The test substance was applied on the skin of 6 rabbits for 24 hours (PSL 1980). Observations at 24 and 72 hr indicated that the test substance is irritating to the skin.
Eye irritation
The test substance was applied in the eye of 6 rabbits (PSL 1980). Based on observations at 24, 48 and 72 h, as well as 6 and 7 days after application, it is concluded that the test substance is irritating to the eyes and needs to be classified as a category 2 eye irritant (H319).
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:
- November 23 - 26, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP, test with formulation, limited information on results (no individual data, only 2 observations), The exposure during 24 hours represents a worst case. The information in the report is limited to the information in the summary.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see below
- Principles of method if other than guideline:
- 6 animals were treated. Exposure period was 24 hours under occlusion. Observations were done at 24 and 72 hours.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Cedar Knolls Farm
- Age at study initiation: not indicated
- Weight at study initiation: not reported
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.5 g
- Concentration (if solution): 50% - Duration of treatment / exposure:
- 24 hours
- Observation period:
- at 24 and 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2
- Type of wrap if used: occlusive; gauze patches, wrapped with rubberized elastic cloth
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize (FHSLA 16 CFR 1500) - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 2.4
- Max. score:
- 3.16
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: only two observations
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 2
- Max. score:
- 2.5
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: only two observations
- Other effects:
- not remarkable
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is irritating to the skin
- Executive summary:
The test substance was applied on the skin of 6 rabbits for 24 hours. Observations at 24 and 72 hr indicated that the test substance is irritating to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- November 26 - December 03, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non GLP test, similar to the OECD 405 guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FHSLA 16 CFR 1500
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see below
- Principles of method if other than guideline:
- 6 animals were treated
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Cedar Knolls Farm
- Age at study initiation: not indicated
- Weight at study initiation: not reported
- Housing: individually (restrained during dosing)
- Diet: Fisher Rabbit Pellets ad libitum
- Water: ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.1 mL
- Concentration (if solution): 50% - Duration of treatment / exposure:
- NA
- Observation period (in vivo):
- scoring after 24, 48 and 72 h , 6 and 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: not indicated - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h (except for one animal prolonged until day 7)
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 2.8
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days (except in one animal including day 7)
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72
- Score:
- ca. 2.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days (except in one animal including day 7)
- Irritant / corrosive response data:
- irritant
- Other effects:
- no effects
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is irritating to the eyes
- Executive summary:
The test substance was applied in the eye of 6 rabbits. Based on observations at 24, 48 and 72 h, as well as 6 and 7 days after application, it is concluded that the test substance is irritating to the eyes and needs to be classified as a catergory 2 eye irritant (H319).
Reference
Animal no |
1 |
2 |
3 |
4 |
|
|
|
|
5 |
|
|
|
|
6 |
|
|
|
|
||||||||||||
time |
24 |
48 |
72 |
6 |
7 |
24 |
48 |
72 |
6 |
7 |
24 |
48 |
72 |
6 |
7 |
24 |
48 |
72 |
6 |
7 |
24 |
48 |
72 |
6 |
7 |
24 |
48 |
72 |
6 |
7 |
cornea |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
redness |
3 |
3 |
2 |
1 |
0 |
3 |
3 |
2 |
0 |
0 |
3 |
3 |
2 |
2 |
2 |
3 |
3 |
3 |
0 |
0 |
3 |
3 |
3 |
1 |
0 |
3 |
3 |
2 |
0 |
0 |
chemosis |
3 |
2 |
1 |
1 |
0 |
2 |
2 |
0 |
0 |
0 |
3 |
3 |
1 |
1 |
0 |
4 |
3 |
2 |
0 |
0 |
4 |
4 |
4 |
2 |
1 |
3 |
3 |
2 |
0 |
0 |
discharge |
3 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
2 |
3 |
0 |
0 |
0 |
2 |
3 |
2 |
0 |
0 |
2 |
3 |
0 |
0 |
0 |
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The available studies contain sufficient information to be used for risk assessment and classification and labelling.
All tests were performed on a 50% formulation. It is not expected that the diluent used has contributed to the effects if any.
Justification for selection of skin irritation / corrosion endpoint:
Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures.
Justification for selection of eye irritation endpoint:
Study was conducted prior to GLP regulations but used a method similar to OECD 405
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on the outcome of the studies, the test substance needs to be classified as irritating to the skin (CLP category 2, H315: Causes skin irritation) and irritating to eyes (CLP category 2 H319: Causes serious eye irritation).
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.
