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Diss Factsheets

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:
September 1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report date:
1965

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethoprophos
EC Number:
236-152-1
EC Name:
Ethoprophos
Cas Number:
13194-48-4
Molecular formula:
C8H19O2PS2
IUPAC Name:
ethyl bis(propylsulfanyl)phosphinate
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Remarks:
albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation: 2.4 - 2.5 kg
- Weight at study initiation: not specified
- Housing: individually, in elevated metal cages
- Diet (ad libitum): Furina Rabbit Pellets
- Water (ad libitum): yes
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
not applicable, no washing
Observation period (in vivo):
1 h
Number of animals or in vitro replicates:
3 animals per sex
Details on study design:

Prior to application, the left eye of each rabbit was examined with 2.0% sodium fluorescein solution to detect any corneal lesions not otherwise visible, and only those animals with eyes free of irritation and corneal damage were used in this study.

A single application of 0.1 mL of the undiluted test material was made into the conjunctival sac of the left eye of each animal. The treated eye was held closed for 30 seconds following application.

The animals were observed for signs of eye irritation and systemic toxicity immediately following instillation and for signs of systemic toxicity during the period preceding death. Necropsies were performed on the animals following death.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
due to acute toxicity (mortality) within 15 min
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Max. score:
3
Remarks on result:
not determinable
Remarks:
due to acute toxicity (mortality) within 15 min
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Max. score:
4
Remarks on result:
not determinable
Remarks:
due to acute toxicity (mortality) within 15 min
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Max. score:
2
Remarks on result:
not determinable
Remarks:
due to acute toxicity (mortality) within 15 min
Irritant / corrosive response data:
Immediately following application of the test item, moderate erythema and vascularization of the sclera and nictitating membrane were noted in all of the treated eyes.
Other effects:
MORTALITY
Within an additional 15 minutes toxic signs were noted in each animal and all animals were dead prior to the one-hour observation.

CLINICAL SIGNS
The following toxic signs were noted: preening, excessive masticatory movements, salivation, blinking, miosis, incoordination of limbs, rapid labored respiration, tremors, clonic and tonic convulsions, and death.

GROSS PATHOLOGICAL EXAMINATION
Necropsies revealed congestion of the lungs, liver, and kidneys and gaseous distention of the gastrointestinal tract.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
A single application of 0.1 mL of the undiluted test substance to the eyes of albino rabbits produced, in all three animals, death within one hour following instillation. Due to the high toxicity of the test item to the rabbit, eye irritating properties were not further investigated.
Executive summary:

In an experimental study from 1965, similar to OECD 405, 0.1 mL of the undiluted test substance was instilled to the left eye of 3 male and female rabbits. The remaining untreated eye served as a control. The animals were observed for signs of eye irritation and systemic toxicity immediately following instillation. Immediately following application of the test item, moderate erythema and vascularization of the sclera and nictitating membrane were noted in all of the treated eyes.


Within an additional 15 minutes toxic signs were noted in each animal and all animals were dead prior to the one-hour observation. The following toxic signs were noted: preening, excessive masticatory movements, salivation, blinking, miosis, incoordination of limbs, rapid labored respiration, tremors, clonic and tonic convulsions, and death. Necropsy was performed and revealed congestion of the lungs, liver, and kidneys and gaseous distention of the gastrointestinal tract.


Under the test condition, the test items eye irritation potential could not be evaluated as all animals died due to the high toxicity of the test item in the rabbit. Therefore, the eye irritating property of the test item was not further investigated.