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Toxicological information

Eye irritation

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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:
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:
read-across source
Qualifier:
equivalent or similar to
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

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.

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. 

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

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.