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EC number: 939-654-5 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 405 (February 24, 1987) and EEC directive 84/449 EEC
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products of ricinoleic acid with 2-aminoethanol and maleic acid and sodium hydrogensulfite
- EC Number:
- 939-654-5
- Molecular formula:
- Molecular formula cannot be given as the substance is a mixture
- IUPAC Name:
- Reaction products of ricinoleic acid with 2-aminoethanol and maleic acid and sodium hydrogensulfite
- Test material form:
- other: 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: Harald Schriever, Kaninchenfarm, D-2740 Bremervörde, Neuendamm 88
- Age at study initiation: No data
- Weight at study initiation: 2.4-2.8 kg
- Fasting period before study: Not applicable
- Housing: Individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system
- Diet (e.g. ad libitum): Ad libitum, Ssniff MÜ Z® (Alleindiät für Zuchtkaninchen),manufactured by Ssniff spezialdiäten GmbH, 4770 Soest/ Westfalen, pellets, 1.0-1.5 cm long, 0.5 cm diameter
- Water (e.g. ad libitum): Ad libitum, drinking nipples, drinking water as for human consumption, analytical and bacteriological controls every six months
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 2 °C (measured with thermohygrometer twice daily)
- Humidity (%): 50-85 % (measured with thermohygrometer twice daily)
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12 (artificial lighting (120 lux) from 7.00 a.m. – 7.00 p.m.
Test system
- Vehicle:
- other: purified water (conductivity < 55 nS/cm)
- Controls:
- other: left eye was tested, right eye was used as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (not more than 100 mg)
- Concentration (if solution): 10 % v/v - Duration of treatment / exposure:
- Eyes were not rinsed after treatment
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Grading of ocular lesions as stipulated by OECD 405
TOOL USED TO ASSESS SCORE: ophtalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.28
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3, #4, #5
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.06
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- CLINICAL EYE OBSERVATION
-At 1 h p.a. all animals showed slight redness and chemosis of the conjunctivae
-At 24 hours p.a. slight conjunctival redness was still present in 5/6 animals and reversible in 1/6 animals. Chemosis persisted 24 hours p.a. only in 1/6 animals and was reversible in the other 5 animals.
-Cornea and iris were at all scorings without any effects.
Any other information on results incl. tables
Table 4. Individual values of ocular gradings
Animal number |
Ocular Lesion |
Hours after treatment |
|||
1 |
24 |
48 |
72 |
||
1 |
Cornea |
0 |
0 |
0 |
0 |
2 |
Cornea |
0 |
0 |
0 |
0 |
3 |
Cornea |
0 |
0 |
0 |
0 |
4 |
Cornea |
0 |
0 |
0 |
0 |
5 |
Cornea |
0 |
0 |
0 |
0 |
6 |
Cornea |
0 |
0 |
0 |
0 |
Table 5: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/1/2/1/1/1 |
1/1/1/2/1/1 |
24 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
1/1/1/1/1/0 |
0/0/0/1/0/0 |
48 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
Average 24, 48, 72 h |
0/0/0/0/0/0 |
0/0/0/0/0/0 |
0.33/0.33/0.33/0.33/0.33/0 |
0/0/0/0.33/0/0 |
Average (mean) 24h, 48h, 72h |
0 |
0 |
0.28 |
0.06 |
Area effected |
- |
- |
- |
- |
Reversibility*) |
- |
- |
c |
c |
Average time for reversion |
- |
- |
48 h |
48 h |
*) Reversibility: c. = completely reversible; = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- According to OECD GHS (2nd rev. edition, UN, 2007) the test item in a 10% (v/v) aqueous solution is classified as non eye irritant.
- Executive summary:
In a primary eye irritation study according to OECD Guideline 405, 0.1 mL of a formulation containing 39% act.ingr. in a 10 % (v/v) aqueous solution was instilled into the conjunctival sac of the left eye of six White New Zealand rabbits. The eyes were not rinsed after substance application. Animals then were observed for 72 hours. At 1 h p.a. all animals showed slight redness and chemosis of the conjunctivae. At 24 hours p.a. slight conjunctival redness was still persistent in 5/6 animals and reversible in 1/6 animals. Chemosis persisted 24 hours p.a. only in 1/6 animals and was reversible in the other 5 animals. From 48 - 72 h p.a. no test article-dependent findings were observed. Active ingredient according to producers information: minimum 39 %.; taking this value into account, active ingredient of the test solution was 3.9 % in minimum.
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