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EC number: 304-990-8 | CAS number: 94313-91-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to the guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: USA Interagency Regulatory Liaison Group (IRLG, January 1981)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate
- EC Number:
- 304-990-8
- EC Name:
- Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate
- Cas Number:
- 94313-91-4
- Molecular formula:
- C17H35N2O.CH3O4S
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Test material form:
- other: Liquid
- Details on test material:
- The test material was a 48% aqueous solution of the substance
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: H. Fortkamp, 4540 Lengerich, Germany
- Weight at study initiation: 2.20 - 2.35 kg
- Age: 11-17 weeks
- Housing: single caging, metal cages
- Diet: ad libitum, Rabbit Diet, Ssniff Versuchstier Diäten GmbH, 4770 Soest/Westfalen, Germany
- Water: ad libitum
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 40-70
- Air changes (per hr): 10 per hour
- Photoperiod: 12 hours daily
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Each animal served as its one control. The test article was introduced into the conjunctival sac of one eye, the untreated eye serving as a control
- Amount / concentration applied:
- 0.1 ml of the test material was instilled into the conjunctival sac of the left eye while the right eye served as control.
- Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- Readings of ocular reactions were made 1-2 h, 24 h, 48 h, 72 h, 4 days, 7 days after treatment.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- PREPARATION OF ANIMALS
- 24 h before treatment eyes were examined for corneal lesions after application of one drop of fluorescein-sodium solution (2%)
APPLICATION OF TEST SUBSTANCE
- 0.1 mL test substance was instilled into the conjunctival sac of the left eye. The lids were then held together for 1-2 seconds. The untreated right eye served as control. Because one of test animals showed a moderate pain reaction (score 3; see table 1), all remaining rabbits received a local anaesthetic in both eyes shortly before the application of the test substance.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not rinsed after treatment
SCORING SYSTEM (modified Draize system): the ocular reactions were assessed using the following numerical scoring system (see table 2)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- #1, #3, #5, #6
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 7 days
- Remarks on result:
- other: Pannus
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- #2, #4
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: delayed opacity formation after 7 days
- Remarks on result:
- other: Pannus
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- #1, #2, #3, #4, #5, #6
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- #2, #3, #4, #5, #6
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- #1, #2, #3, #4, #5, #6
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- #1
- Time point:
- other: 24 h, 48 h, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The most remarkable reaction to the instillation of the test substance was a not discernible iris through cornea opacity in one animal on day 7 after the application. The investigation of the remaining animals showed Pannus formations also on day 7 after the application. As the post exposure observation period was less then 21 days reversibility of effects could not be determined.
- Other effects:
- no data
Any other information on results incl. tables
Table 3: Irritant/corrosive response for each animal at each observation time
Score at time point / Reversibility |
Cornea opacity |
Cornea area |
Iris |
Conjunctivae Redness |
Conjunctivae Chemosis |
Conjunctivae discharge |
Max. score: 4 |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score: 3 |
|
1-2 hours |
1/0/1/0/1/1 |
2/0/2/0/2/2 |
1/1/1/1/1/1 |
2/2/2/2/2/2 |
2/2/2/2/2/2 |
1/1/1/1/1/1 |
1 day |
1/0/1/0/1/1 |
2/0/2/0/2/2 |
1/1/1/1/1/1 |
2/2/2/2/2/2 |
2/2/2/2/2/2 |
2/2/2/2/2/2 |
2 days |
1/0/1/0/1/1 |
2/0/2/0/2/2 |
1/1/1/1/1/1 |
2/2/2/2/2/2 |
2/2/2/2/2/2 |
2/2/2/2/2/2 |
3 days |
1/0/1/0/1/1 |
2/0/2/0/2/2 |
1/1/1/1/1/1 |
2/2/2/2/2/2 |
2/2/2/2/2/2 |
2/2/2/2/2/2 |
4 days |
1/0/1/0/1/1 |
2/0/2/0/2/2 |
1/1/1/1/1/1 |
1/2/2/1/2/2 |
1/2/2/1/2/2 |
1/2/2/1/2/2 |
7 days |
1/2/2/1/3/4 |
4P/4P/4P/4P/4P/4P |
0/0/0/0/0/* |
0/1/1/1/2/2 |
0/1/1/1/2/2 |
0/1/1/0/1/2 |
Average 24h, 48h, 72h |
1/0/1/0/1/1 |
2/0/2/0/2/2 |
1/1/1/1/1/1 |
2/2/2/2/2/2 |
2/2/2/2/2/2 |
2/2/2/2/2/2 |
Reversibility |
n./n./n./n./n./n. |
n./n./n./n./n./n. |
c./c./c./c./c./* |
c./n.c./n.c./n.c./n./n. |
c./n.c./n.c./n.c./n./n. |
c./n.c./n.c./c./n.c./n. |
P = Pannus,
* Evaluation is not possible because of corneal opacity
c. = completely reversible
n.c. = not completely reversible
n.= not reversible
Reactions observed at 2 hours reading after the application
- Clear redness and chemosis of the conjunctiva (score 2)
- Light ocular secretion production (score 1)
- Isolated small diffuse areas in more as a quarter of a cornea (score 1) observed in 4/6 rabbits.
Reactions observed within 1 – 7 days after the application
- Clear redness and chemosis of the conjunctiva (score 2), decreased in 4 animals by the end of the study.
- Moderate pericorneal Hyperaemia of iris (score 1), decreased within the 7 days after the treatment
- Isolated small diffuse areas in more as a quarter of a cornea (score 1) observed in 4/6 rabbits turned into the corneal opacity in all animals by the end of the study.
- Conjunctivae discharge with moistening of the lids and hairs just adjacent to the lids (score 2), decreased in 5/6 of the rabbits by the end of the study.
Table 4: Assessment of results (mean values)
Days after treatment |
Mean values |
|||
Conjunctivae (max. 20) |
Iris (max. 10) |
Cornea (max. 80) |
Mean total score (max. 110) |
|
0 (2 h) |
10 |
5 |
6.7 |
21.7 |
1 |
12 |
5 |
6.7 |
23.7 |
2 |
12 |
5 |
6.7 |
23.7 |
3 |
12 |
5 |
6.7 |
23.7 |
4 |
10 |
5 |
6.7 |
21.7 |
7 |
6.3 |
0* |
43.3 |
49.6 |
*Evaluation is not possible because of corneal opacity
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test material caused serious damage to eyes in this study
- Executive summary:
A primary eye irritation study, performed according to the test plan P 4/152, 3-rd revision, refers to the recommended guidelines of the USA Interagency Regulatory Liaison Group (IRLG, January, 1981). Study performance is comparable to the guideline study.
0.1 ml of the substance (48 % a.i) undiluted were instilled into the conjunctival sac of one eye of 6 young female adult New Zealand White rabbits. Eyes were not washed. Animals then were observed for 7 days. Irritation was scored by the method of Draize.
Calculated mean scores following grading at 24, 48 and 72 hours after installation of the test material for effects on the cornea opacity are 1 for 4 of 6 animals and 0 for 2 of 6 animals. Mean scores for effects on the conjunctiva (redness) and chemosis were 2 for all animals; the effects decreased in 3 of 6 animals were reversible in one animal within 7 days. Mean scores for effects on the iris were 1 for all animals and were fully reversible within 7 days.
As the most remarkable reaction to the instillation of the test substance was cornea opacity (score 4) in one of 6 animals and pannus in all animals at day 7 after application. As the post exposure observation period was less then 21 days reversibility of effects could not be determined.
In this study, the substance (48 % a.i) induced serious damage to eyes.
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