Registration Dossier
Registration Dossier
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EC number: 230-939-3 | CAS number: 7378-99-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 05.02.980 to 08.02.1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP, butq uality assured, observation period 72 h only
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- but quality assurance
Test material
- Reference substance name:
- Dimethyl(octyl)amine
- EC Number:
- 230-939-3
- EC Name:
- Dimethyl(octyl)amine
- Cas Number:
- 7378-99-6
- Molecular formula:
- C10H23N
- IUPAC Name:
- dimethyl(octyl)amine
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): ADMA C-8
- Physical state: clear liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 72 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein on day 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: maximum score after 48 h fully reversible after 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: Maximum score at 4 and 48 h reversed partly to 1 at 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not specified
- Irritant / corrosive response data:
- continuation of table:
chemosis score animal 3 , 24, 48, 72 h, 3 maximum 3 swelling in outer tissue surrounding eye
chemosis score animal 4 , 24, 48, 72 h, 1 maximum 1 reversibility: no data
chemosis score animal 5 , 24, 48, 72 h, 2 maximum 2 reversibility: no data
chemosis score animal 6, 24, 48, 72 h, 0 maximum 0
Conjunctival discharge grade 1 was observed in all animals at 24, 48 and 72 h. - Other effects:
- No other effects were reported.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- One of 6 animals had some corneal damage on day 2 which reversed by day 3. Slight conjunctival redness and chemosis was observed in all animals. As only 2 of 6 animals showed a chemosis score >= 2, the substance does not fulfill the criteria for classification as eye irritant category 2 according to regulation EC No. 1272/2008 and amendments. As most of the effects were reversible or partly reversible within the 3 day observation period, it is not expected that irreversible effects on the eye would occur. Therefore no classification for eye irritation is proposed.
- Executive summary:
The test substance was applied to the conjunctival sac of 6 rabbits in an amount of 0.1 ml. Eye reactions were observed 24, 48 and 72h after application of the test substance. One of 6 animals had some corneal damage on day 2 which reversed by day 3. Slight conjunctival redness and chemosis was observed in all animals. As only 2 of 6 animals showed a chemosis score >= 2, the substance does not fulfill the criteria for classification as eye irritant category 2 according to regulation EC No. 1272/2008 and amendments. As most of the effects were reversible or partly reversible within the 3 day observation period, it is not expected that irreversible effects on the eye would occur. Therefore no classification for eye irritation is proposed.
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