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:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Test-item No.: 08/0016-3
- Batch identification: Tk253_20090901
- Purity Group 1: 18.5 area-%
Group 2: 7.5 area-%
Group 3: 71.2 area-%
Group 4: 2.5 area-%
= 99.7 area-%
- Homogeneity: The test-item was homogeneous by visual inspection.
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage conditions: Room temperature, under N2
- Physical state/ color: Liquid/ colorless, clear

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks
- Weight at study initiation: males (mean): 226.2 g; females (mean): 200.2 g
- Housing: Single housing
- Diet (e.g. ad libitum): VRF1(P); SDS Special Diets Services, 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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk; about 40 cm²
- % coverage: corresponds to at least 10% of the body surface

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.31 mL/kg
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Clinical observations: Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals. Mortality: A check for any dead or moribund animal was made at least once each workday.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross-pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
No systemic clinical signs were observed during clinical examination.
No local effects were observed.
Body weight:
The mean body weight of the male animals increased throughout the study period within the normal range. The mean body weight of the female animals slightly increased throughout the study period.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals examined on the last day of observation.

Applicant's summary and conclusion

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