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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize irritation protocol
Principles of method if other than guideline:
0.1 gram of the substance was instilled into one eye of each of six New Zealand white rabbits. The eyes remained unwashed and were score for irritancy at 1,24,48,72 hours after treatment using the technique of Draize. The study was terminated after 72 hours.
The eye changes were such that all rabbits were negative for irritation at 24 hours as defined in Federal regulations 16 CFR:1500.42.
Six prescreened New Zealand albino rabbits were used in this study. One-tenth of a milliliter of test material was instilled into the conjunctival sac of one eye of each rabbit on day 0 with the contralateral eye serving as a control. In the six rabbits, the treated eyes remained unwashed. The ocular reactions were graded at 1,24,48,72 hours, 4 and 7 days after instillation in accordance with the section 150.42 of the US Federal Hazardous Substance Act. Redness was observed in all rabbit up to 72 hours and chemosis for 5 rabbits after 48hours.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of phosphonic acid, methyl-, bis[(5-ethyl-2-methyl-2,2-dioxido-1,3,2-dioxaphosphorinan-5-yl)methyl] ester with (5-ethyl-2-methyl-2-oxido-1,3,2-dioxaphosphorinan-5-yl)methyl methyl methylphosphonate
EC Number:
915-680-2
Molecular formula:
not applicable for UVCB
IUPAC Name:
Reaction mass of phosphonic acid, methyl-, bis[(5-ethyl-2-methyl-2,2-dioxido-1,3,2-dioxaphosphorinan-5-yl)methyl] ester with (5-ethyl-2-methyl-2-oxido-1,3,2-dioxaphosphorinan-5-yl)methyl methyl methylphosphonate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The eyes remained unwashed and were score for irritancy at 1,24,48,72 hours after treatment using the technique of Draize. The study was terminated after 72 hours.
The eye changes were such that all rabbits were negative for irritation at 24 hours as defined in Federal regulations 16 CFR:1500.42.

Test system

Controls:
yes, concurrent negative control
Duration of treatment / exposure:
72h
Observation period (in vivo):
The eyes remained unwashed and were score for irritancy at 1,24,48,72 hours after treatment using the technique of Draize. The study was terminated after 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: average irritation scores
Time point:
24 h
Score:
ca. 1.3
Max. score:
110
Remarks on result:
no indication of irritation
Irritation parameter:
other: average irritation scores
Time point:
48 h
Score:
ca. 0.3
Max. score:
110
Remarks on result:
no indication of irritation
Irritation parameter:
other: average irritation scores
Time point:
72 h
Score:
ca. 0
Max. score:
110
Remarks on result:
no indication of irritation
Irritation parameter:
other: average irritation scores
Time point:
other: 1h
Score:
ca. 4.7
Max. score:
110

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The material is not a primary eye irritant and is considered as having no effects.