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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation is not sufficient for assessment. Limited information is provided in the study report.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The primary irritation of the skin was determined using the method of draize. Groups of one male and one female with abraded and non-abraded skin were used and the irritation was scored on a 0-4 scale for erythema and oedema.
GLP compliance:
no
Remarks:
Study predates GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 9-icosyl-9-phosphabicyclo[3.3.1]nonane and 9-icosyl-9-phosphabicyclo[4.2.1]nonane
EC Number:
915-206-4
Molecular formula:
C28H55P
IUPAC Name:
Reaction mass of 9-icosyl-9-phosphabicyclo[3.3.1]nonane and 9-icosyl-9-phosphabicyclo[4.2.1]nonane
Details on test material:
- Name of test material (as cited in study report): RM17
- Substance type: No data
- Physical state: White waxy solid at room temperature, somewhat resembling candle wax
- Analytical purity: 89.2%
- Impurities (identity and concentrations):
Light ends 0.2%
RC 78H 0.2%
1-eicosene <0.1%
RC 716 <0.1%
RC 716 oxide 0.1%
Unknown (3) 2.7%
Unknown (6) 2.8%
RM 17 oxide 4.7%
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: 89.2%
- Lot/batch No.: Unable to define samples in terms of batch number
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: The sample actually used to dose the animals was not analysed at the time of dosing. Subsequent analysis of the test material stored in an unsealed drum, however, showed that approximately 40% of the tertiary phosphines had been converted to oxides during several months storage. It is therefore likely that a significant amount of the test material used in the study may have been converted to the oxide during heating of the sample in preparation for dosing.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits, Crawley, Sussex

Test system

Controls:
other: Parrafin was at 45°C

Results and discussion

In vivo

Irritant / corrosive response data:
The hot RM17 appeared to penetrate the skin immediately on application whereas the hot wax appeared to remain on the surface. Seven days after application of RM17 (hot) the skin was hard and cracking, and after 10 days the skin was starting to shed.

Any other information on results incl. tables

The rsults of the erythema (E) and oedema (O) are tabulated below.

Rabbit No sex and chemical

Response

Abraded skin

Non-abraded skin

24 h

72 h

7 days

24 h

72 h

7 days

 

E

O

E

O

E

O

E

O

E

O

E

O

RM17 (hot)

 

 

 

 

 

 

 

 

 

 

 

 

1F

2

2

2-3

2

3-4

2

2

2

3

2

3-4

2

1M

2

1

2-3

2

3

2

2

1

2-3

2

3-4

2

RM17 (cold)

 

 

 

 

 

 

 

 

 

 

 

 

1F

0

0

0

0

0

0

0

0

0

0

0

0

1M

0

0

0

0

0

0

0

0

0

0

0

0

Wax (hot)

 

 

 

 

 

 

 

 

 

 

 

 

1 M

0-1

0

1-2

1

2

2

0

0

0

1

2

2

Applicant's summary and conclusion

Conclusions:
On the basis of the figures RM17 (hot) would be classified as severley irritating, RM17 (cold) as non-irritating and paraffin was (hot) as slightly irritating.