O,O'-dioctadecylpentaerythritol bis(phosphite)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data. The amount of test material instilled into the eye is not reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Section 191.12 (a) (1) and (2) of Federal Register Vol. 29 No. 182 p. 13009

Deviations:

no

Principles of method if other than guideline:

Test material, as a 10 % w/v suspension in cottonseed oil, was instilled into the right eye of each of 6 rabbits. The left eye served as the control and was instilled with cottonseed oil only. Eye reactions were scored over a period of 72 hours following exposure.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

O,O'-dioctadecylpentaerythritol bis(phosphite)

EC Number:

223-276-6

EC Name:

O,O'-dioctadecylpentaerythritol bis(phosphite)

Cas Number:

3806-34-6

Molecular formula:

C41H82O6P2

IUPAC Name:

3,9-bis(octadecyloxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Test material form:

not specified

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Test system

Vehicle:

other: cottonseed oil

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Test material was tested as a suspension in cottonseed oil. Prepared by dissolving 1 g test material in methylene chloride then adding 10.0 mL of cottonseed oil, and evaporating the solvent on a steam bath.
- Concentration (if solution): 10 % w/v

Duration of treatment / exposure:

Animals recieved a single treatment of test material suspension

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0.11

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: (no effects)

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: (no effects)

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Reversibility:

fully reversible

Remarks on result:

other: (no effects)

Irritant / corrosive response data:

The test material produced a very mild conjunctival effect in two of the animals which cleared by the second day of observations. No other eye reactions were noted during the study.

Any other information on results incl. tables

Table 2: Individual daily scores

	Tissue		Right eye (treated)			Left eye (control)
			Day
			1	2	3	1	2	3
Rabbit No. 1	Cornea	Opacity	0	0	0	0	0	0
		Area	0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Redness	1	0	0	0	0	0
		Chemosis	0	0	0	0	0	0
		Discharge	0	0	0	0	0	0
Rabbit No. 2	Cornea	Opacity	0	0	0	0	0	0
		Area	0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Redness	0	0	0	0	0	0
		Chemosis	0	0	0	0	0	0
		Discharge	0	0	0	0	0	0
Rabbit No. 3	Cornea	Opacity	0	0	0	0	0	0
		Area	0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Redness	0	0	0	0	0	0
		Chemosis	0	0	0	0	0	0
		Discharge	0	0	0	0	0	0
Rabbit No. 4	Cornea	Opacity	0	0	0	0	0	0
		Area	0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Redness	0	0	0	0	0	0
		Chemosis	0	0	0	0	0	0
		Discharge	0	0	0	0	0	0
Rabbit No. 5	Cornea	Opacity	0	0	0	0	0	0
		Area	0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Redness	0	0	0	0	0	0
		Chemosis	0	0	0	0	0	0
		Discharge	0	0	0	0	0	0
Rabbit No. 6	Cornea	Opacity	0	0	0	0	0	0
		Area	0	0	0	0	0	0
	Iris		0	0	0	0	0	0
	Conjunctiva	Redness	1	0	0	0	0	0
		Chemosis	0	0	0	0	0	0
		Discharge	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the test material only produced a very mild conjunctival effect in two of the animals which cleared by the second day of observations. No other eye reactions were noted during the study.

Executive summary:

The eye irritation potential of the test material was investigated according to the method described under Section 191.12 (a) (1) and (2) of the Federal Register Vol. 29 No. 182 (1964) p. 13009. During the study, test material, as a 10% w/v suspension in cottonseed oil, was instilled into the right eye of each of 6 rabbits. The left eye served as the control and was instilled with cottonseed oil only. Eye reactions were scored over a period of 72 hours following exposure. Under the conditions of the study, the test material only produced a very mild conjunctival effect in two of the animals which cleared by the second day of observations. No other eye reactions were noted during the study.