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EC number: 298-697-1 | CAS number: 93821-12-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978-11-28 to 1978-12-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is rated "reliable with restrictions" this study was not conducted according to GLP, but was conducted similar to OECD 405.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1978-11-28 to 1978-12-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is rated "reliable with restrictions" this study was not conducted according to GLP, but was conducted similar to OECD 405.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace animals, P.O. Box 122, Boyertown, PA
- Age at study initiation: 8 weeks
- Weight at study initiation: 1.8 to 3.5 kg
- Housing: Housed 2 per cage in elevated wire mesh cages
- Diet (e.g. ad libitum): Fresh Purina rabbit chow; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Data not provided
- Humidity (%): Data not provided
- Air changes (per hr): Data not provided
- Photoperiod (hrs dark / hrs light): Data not provided - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- Single instillation; 4 hours
- Observation period (in vivo):
- 1 and 4 hours and on days 1, 2, 3, 4, and 7
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Data not reported
- Time after start of exposure: Data not reported
SCORING SYSTEM: Draize method; 1959
TOOL USED TO ASSESS SCORE: Fluorescein - Irritation parameter:
- overall irritation score
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- other: 4 hours
- Score:
- ca. 10.17
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores at 24/48/72 hours not provided; only overall irritation score available
- Irritation parameter:
- iris score
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores at 24/48/72 hours not provided; only overall irritation score available
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores at 24/48/72 hours not provided; only overall irritation score available
- Irritation parameter:
- chemosis score
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores at 24/48/72 hours not provided; only overall irritation score available
- Irritant / corrosive response data:
- Slight to moderate irritation was noted during the 1st and 4th hour following instillation. Slight irritation continued to be seen on day 2 in 2 rabbits
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- MRD-ECH-78-36 was not-irritating to rabbit eyes.
- Executive summary:
In an acute eye irritation test, six white rabbits were instilled with 0.1 mL of MRD-78-36 into the conjunctival sac of one eye. Following instillation, the treated eyes were held shut for a few minutes to ensure adequate distribution of the test material. The untreated eye served as control. All animals were observed for overt signs of toxicity and for irritation of the cornea, iris, and conjunctiva at 1 and 4 hours, and on days 1, 2, 3, 4 and 7. Fluorescein was used in examining ocular irritation on days 7, 10 and 14. Ocular irritation was scored using the Draize system of eye irritation (1959).
No overt signs of toxicity were noted in any of the animals. Slight to moderate irritation was noted during the 1st and 4th hour following instillation. Slight irritation continued to be seen on day 2 in two rabbits. Based on these results, the study authors concluded that the test material is not irritating when instilled into rabbit eyes.
This study received a Klimisch score of 2 and is classified as “reliable with restrictions” because this study was not conducted according to GLP, but was conducted similar to OECD 405.
No overt signs of toxicity were noted in any of the animals. Slight to moderate irritation was note during the 1st and 4th hour following instillation. Slight irritation continued to be seen on day 2 in two rabbits.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Alkenes, C6-8-branched, C7 rich
- IUPAC Name:
- Alkenes, C6-8-branched, C7 rich
- Reference substance name:
- Alkenes, C6-8-branched, C7-rich
- EC Number:
- 307-298-4
- EC Name:
- Alkenes, C6-8-branched, C7-rich
- Cas Number:
- 97592-99-9
- IUPAC Name:
- Alkenes, C6-8-branched, C7-rich
- Details on test material:
- - Name of test material (as cited in study report): MRD-ECH-78-36 (Alkenes)
- Substance type: Alkenes, C6-8-branched, C7 rich
- Physical state: Clear liquid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace animals, P.O. Box 122, Boyertown, PA
- Age at study initiation: 8 weeks
- Weight at study initiation: 1.8 to 3.5 kg
- Housing: Housed 2 per cage in elevated wire mesh cages
- Diet (e.g. ad libitum): Fresh Purina rabbit chow; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Data not provided
- Humidity (%): Data not provided
- Air changes (per hr): Data not provided
- Photoperiod (hrs dark / hrs light): Data not provided
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- Single instillation; 4 hours
- Observation period (in vivo):
- 1 and 4 hours and on days 1, 2, 3, 4, and 7
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Data not reported
- Time after start of exposure: Data not reported
SCORING SYSTEM: Draize method; 1959
TOOL USED TO ASSESS SCORE: Fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- other: 4 hours
- Score:
- ca. 10.17
- Max. score:
- 110
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores at 24/48/72 hours not provided; only overall irritation score available
- Irritation parameter:
- iris score
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores at 24/48/72 hours not provided; only overall irritation score available
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores at 24/48/72 hours not provided; only overall irritation score available
- Irritation parameter:
- chemosis score
- Basis:
- animal: Mean of animals (1-6)
- Time point:
- 24/48/72 h
- Remarks on result:
- other: Individual animal scores at 24/48/72 hours not provided; only overall irritation score available
- Irritant / corrosive response data:
- Slight to moderate irritation was noted during the 1st and 4th hour following instillation. Slight irritation continued to be seen on day 2 in 2 rabbits
Any other information on results incl. tables
No overt signs of toxicity were noted in any of the animals. Slight to moderate irritation was note during the 1st and 4th hour following instillation. Slight irritation continued to be seen on day 2 in two rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- MRD-ECH-78-36 was not-irritating to rabbit eyes.
- Executive summary:
In an acute eye irritation test, six white rabbits were instilled with 0.1 mL of MRD-78-36 into the conjunctival sac of one eye. Following instillation, the treated eyes were held shut for a few minutes to ensure adequate distribution of the test material. The untreated eye served as control. All animals were observed for overt signs of toxicity and for irritation of the cornea, iris, and conjunctiva at 1 and 4 hours, and on days 1, 2, 3, 4 and 7. Fluorescein was used in examining ocular irritation on days 7, 10 and 14. Ocular irritation was scored using the Draize system of eye irritation (1959).
No overt signs of toxicity were noted in any of the animals. Slight to moderate irritation was noted during the 1st and 4th hour following instillation. Slight irritation continued to be seen on day 2 in two rabbits. Based on these results, the study authors concluded that the test material is not irritating when instilled into rabbit eyes.
This study received a Klimisch score of 2 and is classified as “reliable with restrictions” because this study was not conducted according to GLP, but was conducted similar to OECD 405.
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