Registration Dossier
Registration Dossier
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EC number: 618-848-0 | CAS number: 92413-47-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17.04.-09.05.1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 618-848-0
- EC Number:
- 618-848-0
- Cas Number:
- 92413-47-3
- Molecular formula:
- C16H28O
- IUPAC Name:
- 618-848-0
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: SAVO-Ivanovas, Kisslegg
- Age at study initiation: about 17 - 19 weeks
- Housing: Healthy young rabbits were allocated to the different groups. The animals were kept in the experimental room for more than 7 days to allow for acclimatization. All rabbits were housed in an air-conditioned room of 39 m2 (No. 123) in the rabbit experimental station with daylight. They were kept separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm2, height: 38 cm; manufacturer: Hulskamp) on metal grids. The paper underneath the cages was changed three times a week. The cages were machine-cleaned before the start of the study. The temperature varied from 21 to 24°C and the humidity from 43 to 64 %. The measurements were carried out using a thermohygrograph (type 252, Wilhelm Lambrecht KG, Göttingen).
- Diet: The rabbits received Altromin Standard Diet TPF(R) 2113, pellets and acidified, fully demineralized water from an automatic drinking device ad libitum. The diet is checked periodically by an independent and German Government approved testing laboratory, according to the regulations of the manufacturer. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics. Drinking water employed in this type of study is regularly investigated microbiologically. The analytical results show that the limits set by German regulations for animal feed have not been exceeded..
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- After instillation the eyelids were closed for about 30 seconds. Rinsing of the eyes was not performed.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- After single instillation of 0.1 g test item, into the conjunctival sac of the left eye, without rinsing, no irritation of the cornea and iris was observed. Examination of the conjunctivae revealed redness
(score 1), chemosis in 1 animal (score 2 = positive effect), and discharge (score 1 or 2) at the first reading. At the second reading only redness (score 1) was seen in 1 animal. Later, no irritation was seen. The chemosis at the first reading was probably due to incidental mechanical irritation. According to these results the test material is not regarded as an irritant. - Other effects:
- There was no mortality and no signs of toxicity were observed during the study period. The body weight gains were within the normal ranges during the study period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not irritating to eye.
- Executive summary:
The test item was tested for its eye irritating properties. For the test of primary eye irritation, 0.1 g of the test material was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The other examinations were performed daily for further 7 days.
Examination of the conjunctivae revealed redness (score 1), chemosis in 1 animal (score 2 = positive effect), and discharge (score 1 or 2) at the first reading. At the second reading only redness (score 1) was seen in 1 animal. Later on no irritation was seen. The chemosis at the first reading was probably due to incidental mechanical irritation. According to these results the test material is not regarded as an irritant.
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