O,O'-dioctadecylpentaerythritol bis(phosphite)

Endpoint summary

Description of key information

Skin; not irritating; rabbit; Federal Register Vol. 41 No. 118 (1976) p. 42572; Levi (1977)
Eye; not irritating; rabbit (10% w/v solution); Federal Register Vol. 29 No. 182 (section 191.12 (a) (1) and (2)) p. 13009; Moldovan (1971)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

13 Decmber 1977 to 15 December 1977

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.

Qualifier:

according to guideline

Guideline:

other: Federal Register Vol. 41No. 118 (1976) p. 42572

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

only observations for ulceration and necrosis were performed. Observations were performed only up to 48 hours.

Principles of method if other than guideline:

0.5 g of test material was applied to the skin of 6 male rabbits for 4 hours. At the end of the exposure period, the test material was removed and skin reactions recorded over the 48 hour study period.

GLP compliance:

no

Species:

rabbit

Strain:

other: albino

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

48 hours

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: Hair was clipped from the abdomen of the animals.
- Type of wrap: Test material was placed on the skin under a small square of cotton gauze, held in place with a larger square of polyethylene film secured with strips of adhesive tape. A square of flannel cloth was then taped around the trunk of the animal to further protect the patches from being dislodged.

REMOVAL OF TEST SUBSTANCE
After 4 hours the vest and patches were removed and the skin examined for signs of irritation. The test site was washed with an appropriate solvent to prevent further exposure.

SCORING SYSTEM: Corrosion was considered to have resulted if the test material caused destruction or irreversible alteration of the tissue. Tissue destruction was considered to have occurred if, at any of the readings, there was ulceration or necrosis. Tissue destruction did not include sloughing of the epidermis, or erythema, oedema, or fissuring.

Table 1: Skin Corrosivity - Individual Reactions

Animal number	4 hours		48 hours
	Necrosis	Ulceration	Necrosis	Ulceration
1495	no	no	no	no
1496	no	no	no	no
1497	no	no	no	no
1498	no	no	no	no
1519	no	no	no	no
1520	no	no	no	no

Interpretation of results:

other: Not possible to classify based on the available information

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Application of the test material to the skin of rabbits produced no necrosis or ulceration up to 48 hours after 4 hours under occlusive exposure.

Executive summary:

The skin corrosivity of the test material was investigated following the method outlined in Federal Register Vol. 41, No. 118 (1976) p 42572. During the study, 0.5 g test material was applied to the skin of 6 rabbits, under an occlusive dressing, for a period of 4 hours. After 4 hours, the test material was removed from the test site and skin reactions recorded. A further evaluation of skin reaction occurred at 48 hours. Under the conditions of the study application of the test material to the skin of rabbits produced no necrosis or ulceration.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

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

Species:

rabbit

Strain:

other: albino

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

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

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)

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)

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.

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

 

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation

In the key study, the skin corrosivity of the test material was investigated following the method outlined in Federal Register Vol. 41, No. 118 (1976) p 42572. During the study, 0.5 g test material was applied to the skin of 6 rabbits, under an occlusive dressing, for a period of 4 hours. After 4 hours, the test material was removed from the test site and skin reactions recorded. A further evaluation of skin reaction occurred at 48 hours. Under the conditions of the study application of the test material to the skin of rabbits produced no necrosis or ulceration. Therefore, the test material is not considered to be a corrosive agent.

 

Based on the dermal irritation observations reported in the most recent acute dermal toxicity study, and the results of the available in vivo corrosivity test, the available information is sufficient for classification and labelling and risk assessment purposes. Considering all the available information as part of an integrated testing strategy, as recommended by the OECD Guideline 404. The test material is considered to be neither corrosive, nor irritating to the skin.

 

Eye Irritation

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.

Justification for selection of skin irritation / corrosion endpoint:
Only one study available

Justification for selection of eye irritation endpoint:
Only one study available

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for skin or eye irritation.