Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with full report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Identification : Perkadox BC FF
- Substance type: white crystalline powder
- Physical state: solid
- Analytical purity: 99.4%
- Lot/batch No.: 0419908022443
- Expiration date of the lot/batch: 04.10.2000

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: m= 314+/-26 g, f = 220+/- 12g
- Fasting period before study:
- Housing:
- Diet: pelleted laboratory animal diet (from Carfil Quality BVBA)
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
corn oil
Details on dermal exposure:
TEST SITE
- Area of exposure: 25 cm2 for males and 18 cm2 for females
- % coverage: 10
- Type of wrap if used: dressing, consisted of surgical gauze patch, successively covered with aluminium foil and Coban flexible bandage (Micropore tape used additionally in females only)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 24h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg (10 ml/kg)
Duration of exposure:
24h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality twice daily, body weights d1, d8 and d15, clinical signs daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
No clinical signs of systemic toxicity were noted in any of the animals.
Body weight:
The changes in body weight gain in both sexes were within the range expected for rats used in such studies and were therefore considered not indicative fo toxicity.
Gross pathology:
No abnormalities were found at macroscopic pots mortem examination.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 value of the substance was found to be greater than 2000 mg/kg bw.
Executive summary:

In a study performed according to OECD 402, no deaths occurred in either sex of rats during the observation period at a limit dose of 2000 mg/kg. Abnormalities of general condition were not observed in any males or females during the observation period. Therefore, the LD50 is >2000 mg/kg.