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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1987)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetraphenylphosphonium phenolate
EC Number:
239-480-3
EC Name:
Tetraphenylphosphonium phenolate
Cas Number:
15464-47-8
Molecular formula:
C24H20P.C6H5O
IUPAC Name:
tetraphenylphosphanium benzenolate
Constituent 2
Chemical structure
Reference substance name:
Phenol
EC Number:
203-632-7
EC Name:
Phenol
Cas Number:
108-95-2
Molecular formula:
C6H6O
IUPAC Name:
phenol
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: HsdCpb: Wu
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: approximately 9 weeks for males, about 12 weeks for females
- Weight at study initiation: males 237-251 g; females 196-207 g
- Housing: The animals were caged individually in polycarbonate cages on low dust wood granulate bedding.
- Diet and water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
One day before the start of the treatment the back and flanks of the rats were shorn. For each dose and animal the required amount of the solid test substance was weighed out and applied to a wet gauze-layer (6.0 cm x 5.0 cm = 30.0 cm²) of a "Cutiplast steril" coated with air-tight "Leukoflex". The gauze strip was placed on the rat's back and secured with a "Lomir biomedical Inc rat jacket", which was connected with a safety pin to the stretch tape to ensure that the animals could not ingest the test substance.

REMOVAL OF TEST SUBSTANCE
After approximately 24 hours the dressings were removed and the area was rinsed with water and soap and gently patting the area dry.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw per 30.0 cm²
Dose range: males 30.1 - 31.9 mg/cm²; females 28.0 - 29.6 mg/cm².
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: at least 14 days
- Frequency of observations and weighing: Clinical signs and mortality rates were determined several times on the day of application and subsequently at least once daily. The weight gain of the animals was checked weekly until the end of the study.
- Necropsy of survivors performed: yes
Statistics:
An assessment of the LD50 was made based on the applied dose and a software program according to Spearman and Kärber, if appropriate.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities occurred.
Clinical signs:
No clinical signs were observed.
Body weight:
There were no toxicologically significant effects on body weight or body weight development in males and females.
Gross pathology:
The necropsies performed at the end of the study revealed no particular findings.
Other findings:
one male showed local skin effects (treatment area was partly encrusted on day 11 of the study).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

An acute dermal toxicity study was performed according to OECD TG 402. For the purpose of a limit test 2000 mg/kg of the test item was applied occlusively to the skin of 5 male and 5 female rats for 24 hours. No mortalities, no clinical signs, no effects on weight development and no gross pathological findings were observed during the 14-days observation period. One male showed local skin effects (treatment area was partly encrusted) on day 11 of the study only. The resulting LD50 was thus determined with > 2000 mg/kg bw for both sexes combined.