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: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
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-item: Golpanol ALS wasserfrei
- Test-item No.: 09/0505-1
- Batch identification: 04749356P0
- Purity Golpanol ALS: 71.3 %
- Impurities (identity and concentrations): NaCl 26.0%
Storage conditions: Room temperature
Physical state/ color: Solid/ white

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: Young adult animals (male animals approx. 8, female animals approx. 12 weeks)
- Weight at study initiation: 225 - 243 g
- Housing: Single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 – 26
- Humidity (%): 20 – 80
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
doubly distilled
Details on dermal exposure:
TEST SITE
- Area of exposure: About 40 cm²
- % coverage: corresponds to at least 10 % of the body surface

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 ml/kg body weight
- Concentration (if solution):40 g/100 ml
Duration of exposure:
24 h exposure
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: yes, Necropsy with gross-pathology examination on the last day of the observation period.
- Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), as a rule weekly thereafter and on the last day of observation.
- Mortality: A check for any dead or moribund animal was made at least once each workday, these records are archived by Bioassay.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No local or systemic effects observed.
Mortality:
No mortality occured.
Clinical signs:
Systemic effects: No systemic clinical signs were observed during clinical examination.
Body weight:
The mean body weight of the animals increased throughout the study period within the normal range.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined at termination of the study.
Other findings:
No local effects were observed.

Applicant's summary and conclusion