Registration Dossier
Registration Dossier
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EC number: 248-777-7 | CAS number: 28015-99-8
Eye irritation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- magnesium bis(di C8-C10, branched, C9 rich, alkylnaphtalene sulphonate)
- IUPAC Name:
- magnesium bis(di C8-C10, branched, C9 rich, alkylnaphtalene sulphonate)
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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).
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