Registration Dossier
Registration Dossier
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EC number: 800-362-7 | CAS number: 1307863-78-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- between 21 and 28 August 1984
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Oleyl diamine, dioleate
- IUPAC Name:
- Oleyl diamine, dioleate
- Test material form:
- other: liquid
- Details on test material:
- Sample designation: EN 455
Chemical name: N-oleyl 1,3-diaminopropane di oleate.
Purity: assay: 95%
Aspect: amber liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Morton Commercial Rabbits, Stansted, Essex
- Age at study initiation: approximately 9 to 11 weeks of age
- Weight at study initiation: 2.1 to 2.3 kg
- Housing: individually housed in metal cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not indicated; The rabbits selected for the study were all acclimated to the laboratory environment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): 30-70%.
- Air changes (per hr): Air exchange was maintained at approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: between 21 and 28 August 1984
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- Eye were not flushed after installation.
- Observation period (in vivo):
- Observations post application at 1 hour and after 1, 2, 3, 4 and 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage or conjunctival inflammation.
A 0.1 ml aliquot of EN 455 was placed into the lower everted lid of one eye of each animal.
The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated and served as a control.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: all animals reach avg score ≥1
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: None of the animals reach an avg score ≥ 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: All animals reach avg score ≥ 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 2.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: All animals reach avg score ≥ 2
- Irritant / corrosive response data:
- The numerical scores awarded to the ocular reactions elicited by EN 455 are given in the table on ocular reactions.
All three animals gave a "positive" response.
Corneal opacities developed in all three animals.
Temporary iritis was seen in one animal.
A diffuse crimson red colouration of the conjunctivae was observed in all three animals and was accompanied by considerable swelling with partial eversion of the eyelids or with the eyelids about half-closed.
The eyes were normal seven days after instillation.
There were no other lesions.
Any other information on results incl. tables
Ocular reactions:
rabbit |
Region of Eye |
One hour |
Day after instillation |
Result |
|||||
1 |
2 |
3 |
4 |
7 |
|||||
960 (female) |
Cornea |
0 |
2 |
2 |
2 |
2 |
0 |
+ |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
2 |
2 |
2 |
2 |
2 |
0 |
||
Chemosis |
2 |
3 |
2 |
2 |
2 |
0 |
|||
961 (female) |
Cornea |
0 |
1 |
1 |
1 |
1 |
0 |
+ |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
2 |
2 |
2 |
2 |
2 |
0 |
||
Chemosis |
2 |
2 |
2 |
2 |
1 |
0 |
|||
978 (female) |
Cornea |
0 |
2 |
2 |
2 |
2 |
0 |
+ |
|
Iris |
0 |
1 |
1 |
0 |
0 |
0 |
|||
Conjunctivae |
Redness |
2 |
2 |
2 |
2 |
2 |
0 |
||
Chemosis |
2 |
3 |
2 |
2 |
2 |
0 |
|||
Classification for GHS Cat.2 is fulfilled, as:
- at least 2 of the three animals show an mean (24, 48 and 72 hr) score for corneal opacity ≥ 1 (all three animals),
- at least 2 of the three a mean conjunctival redness of ≥ 2 (all three),
- at least 2 of the three a mean conjunctival chemosis of ≥ 2 (all three)
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Oleyl diamine, dioleate was irritating in the in vivo eye irritation test in rabbits. The effects were fully reversible within 7 days. The study results indicate that the substance should be classified Cat.2 irritating to the eyes for GHS.
- Executive summary:
The eye irritation potential of Oleyl diamine, dioleate was assessed in an in vivo eye irritation study in rabbits according to OECD 405, and in compliance with GLP.
A 0.1 ml aliquot of Oleyl diamine, dioleate was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated and served as a control.
Examination of the eyes was made after 1 hour and 1, 2, 3, 4, and 7, days after instillation. Observation of the eyes was aided by the use of a handheld torch.
Results:
All three animals gave a "positive" response.
Corneal opacities developed in all three animals.
Temporary iritis was seen in one animal.
A diffuse crimson red colouration of the conjunctivae was observed in all three animals and was accompanied by considerable swelling with partial eversion of the eyelids or with the eyelids about half-closed.
The eyes were normal seven days after instillation.
There were no other lesions.
According the GHS criteria, these results indicate that the substance should be classified Cat.2 for eye irritation according to GHS.
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