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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions
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:
according to guideline
Guideline:
other: No data
Principles of method if other than guideline:
Species: New Zealand White rabbits
Exposure: Single exposure to 1, 2 and 4 g/kg
Examinations: Mortalities, sublethal effects and necropsy
GLP compliance:
no
Remarks:
Study predates GLP
Test type:
other: No data
Limit test:
no

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
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits, Crawley, Sussex.
- Age at study initiation: No data
- Weight at study initiation: 3-4 kg
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal
- % coverage: No data
- Type of wrap if used: No data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: 6 hours
Duration of exposure:
6 hours
Doses:
1, 2 and 4 g/kg
No. of animals per sex per dose:
2
Control animals:
no
Details on study design:
- Necropsy of survivors performed: yes
- Other examinations performed:
After gross post mortem examination, the following tissues were taken from the animals for a detailed histopathological examination using haematoxylin and eosin, Luxol fast blue, cresyl violet and Glees and Marsland stains:
Right & left sciatic nerves (LS sections)
Right & left posterior tibial nerves (LS sections)
Spinal cord at two levels (TS sections)
Brain at three levels: Cerebellum TS, Thalmus TS and Anterior cerebrum TS

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 4 other: g/kg
Remarks on result:
other: Result probably misleading as test substance solidifed on skin and could not be removed
Mortality:
One death occured at 4 g/kg within 2 days of dosing following cessation of eating and subdued behaviour.
Clinical signs:
Animals dosed with 4 g/kg showed skin irritation and were subdued for several days after dosing, but the lower dose animals were unaffected.

Any other information on results incl. tables

The molten RM`7 solidified rapidly when applied to the skin and was impossible to remove later without recourse to unacceptable methods. Consequently to quote an acute LD50 value of approximately 4 g/kg is probably misleading since it is impossible to estimate the period of application of the test material.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 value is probably misleading since it was impossible to estimate the period of application to the skin.