Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-04-08 through 1992-04-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HR 92/600154
- Analytical purity: 98.5%
- Impurities (identity and concentrations):
- Physical state: viscous liquid
- Lot/batch No.: 2010002
- Stability under test conditions: yes
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Ltd., Manston, Kent, U.K.
- Age at study initiation: 10 to 14 weeks
- Weight at study initiation: males 213-235 g; females 202-222 g
- Fasting period before study: not required
- Housing: singly until day 1 post treatment, in groups of 5 thereafter
- Diet: ad libitum (Rat and Mouse Expanded Diet No. 1)
- Water: tap water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21°C
- Humidity (%): 52-60%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5x4 cm
- % coverage: 10% of total body surface
- Type of wrap if used: surgical gauze, covered by a piece of self-adhesive bandage (HYPERTIE), secured with a piece of BLENDEM wrapped around each end


REMOVAL OF TEST SUBSTANCE
- Washing: with distilled water to remove excess test material
- Time after start of exposure: 24 hours after treatment


TEST MATERIAL
- Amount applied: 2000 mg/kg
- Constant volume or concentration used: yes

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations at least once daily; weighing on days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not needed

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity or skin irritation were noted during the study.
Body weight:
There was no effect on body weight.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU