Reaction Products of Dimethyl hydrogen phosphite and Alcohols C14-18, Even, Linear

Endpoint summary

Description of key information

Skin - Not irritation to the skin of rabbits 
Eye - Not irritating in vivo to the eye of rabbits. 

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:

key study

Study period:

02 March 1974 to 18 April 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-GLP study

Qualifier:

equivalent or similar to guideline

Guideline:

other: US Federal Hazardous Substances Labelling Act

Principles of method if other than guideline:

The method employed in the testing was similar to that described in Section 1500.41 - Hazardous Substances and Articles. Administration and Enforcement Regulations, Federal Register, Vol 38 No 187 P.27019, 27 September 1973. Six albino rabbits were clipped, one side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. Gauza patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used

GLP compliance:

no

Remarks:

Prior to GLP

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No details on test animals and environment provided

Type of coverage:

occlusive

Preparation of test site:

other: Clipped with abraded and intact sites on each animal

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

24 hour occlusive exposure. The sites were not washed after the patches were removed.

Observation period:

24 and 72 hours

Number of animals:

6

Details on study design:

Six albino rabbits were clipped, one side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. Gauza patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 & 72 hours

Score:

2

Max. score:

4

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 & 72 hours

Score:

2

Max. score:

4

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24 & 72 hours

Score:

2

Max. score:

4

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: 24 & 72 hours

Score:

2

Max. score:

4

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

other: 24 & 72 hours

Score:

2

Max. score:

4

Reversibility:

no data

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: 24 & 72 hours

Score:

2

Max. score:

4

Reversibility:

no data

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 & 72 houts

Score:

0

Max. score:

4

Reversibility:

no data

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24 & 72 hours

Score:

0

Max. score:

4

Reversibility:

no data

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24 & 72 hours

Score:

0

Max. score:

4

Reversibility:

no data

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: 24 & 72 hours

Score:

0

Max. score:

4

Reversibility:

no data

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: 24 & 72 hours

Score:

0

Max. score:

4

Reversibility:

no data

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: 24 & 72 hours

Score:

0

Max. score:

4

Reversibility:

no data

Irritant / corrosive response data:

Intact skin only
The test item elicited a well defined erythema response in all animals at the 24 and 72 hour observation. No other irritation response were noted.

Irritation effects on the intact skin only are considered for classification purposes.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for skin irritation is not required.

Executive summary:

Introduction

The study was performed in accordance with the US Federal Hazardous Substances Labelling Act to assess the irritancy potential of the test item to the skin of rabbits.

Method and materials

The intact and abraded skin of 6 rabbits was used. The hair was clipped from the backs of the rabbits. One side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. GauzE patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used.

Results

A single 24-Hour, occluded application of the test item to the intact skin of six rabbits produced a well defined erythema response in all six animals at the 24 & 72 -hour observation No other irritation responses were noted.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for skin irritation is not required.

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Pre-GLP study

Qualifier:

according to guideline

Guideline:

other: US Federal Hazardous Substances Labeling Act

Deviations:

not applicable

Principles of method if other than guideline:

Six rabbits were used in this study, 0.1g of the test material was instilled into the right eyes of the animals, the other eyes remained untreated to serve as controls. The test material was not washed from the eyes. The treated eyes were examined at 1,2 and 3 days following instillation.

GLP compliance:

no

Remarks:

Prior to GLP

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No details on test animals and environment provided

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1g

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

Days 1, 2, 3

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Illustrated Guide for Grading Eye Irritation by Hazardous Substances

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, & 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: No effect observed

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 & 72 hours

Score:

0

Max. score:

2

Remarks on result:

other: No effect observed

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 & 72 hours

Score:

0

Max. score:

3

Remarks on result:

other: No effect observed

Irritant / corrosive response data:

No effects shown

Other effects:

No data

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material is not an irritant to the eyes of rabbit under the conditions of the study. The test item is not classifiable under CLP.

Executive summary:

Introduction

The study was performed in accordance with the US Federal Hazardous Substances Labelling Act.

Method

A volume of 0.1g of the test item was placed into one eye of six rabbits. The eyes were left unwashed and observations were perfomed on day 1 and then daily for a period of 3 days. Assessment of ocular damage/irritation was made according to the Illustrated gide for Grading Eye Irritation by Hazardous Substances

Results

A single application of the test item to the non-irrigated eye of six rabbits produced no effects.

Conclusion

The test material is not an irritant in the eye of rabbits. The test item is not classifiable under CLP.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

SKIN

The study was performed in accordance with the US Federal Hazardous Substances Labelling Act to assess the irritancy potential of the test item to the skin of rabbits. The intact and abraded skin of 6 rabbits was used. The hair was clipped from the backs of the rabbits. One side of the animals' back was abraded with a lancet sufficiently deep to penetrate the stratum cornium but not enter the derma. The skin of the other side remained intact. A 0.5g of test item was applied to an abraded and an intact skin site on the same rabbit. Gauza patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks of the rabbits to hold the patches in place. The wrapping was removed at the end of the 24-hour period and the treated areas were examined. Readings were also made at 72-hours. The Draize method of scoring was used

A single 24-Hour, occluded application of the test item to the intact skin of six rabbits produced a well defined erythema response in all six animals at the 24 & 72 -hour observation No other irritation responses were noted.

Supporting date for the Acute Dermal Toxicity Study, showed individual dermal reactions for up to 14 days and there were no effects seen.

In accordance with EU CLP Regulation (EC) No. 1272/2008 classification of this substance for skin irritation is not required.

EYE

The study was performed in accordance with the US Federal Hazardous Substances Labelling Act. A volume of 0.1g of the test item was placed into one eye of six rabbits. The eyes were left unwashed and observations were perfomed on day 1 and then daily for a period of 3 days. Assessment of ocular damage/irritation was made according to the Illustrated gide for Grading Eye Irritation by Hazardous Substances

A single application of the test item to the non-irrigated eye of six rabbits produced no effects. The test material is not an irritant in the eye of rabbits. The test item is not classifiable under CLP.

Justification for selection of skin irritation / corrosion endpoint:
Pre-GLP study providing adequate description of experimental methods.

Justification for selection of eye irritation endpoint:
Pre-GLP study providing adequate description of experimental methods.

Justification for classification or non-classification

SKIN

In the dermal irritation study, treatment with the test item resulted in erythema scores of 2 and edema scores of 0 in six animals at 24 and 72 hours, which is not sufficient for the substance to be classified under the terms of EU CLP Regulation (EC) No. 1272/2008.

EYE

Treatment with the test item caused no effects (cornea, iris and conjunctivae scores 0 at 24, 48 and 72 hours), which is not sufficient for the substance to be classified under the terms of EU CLP Regulation (EC) No. 1272/2008.