Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-08-18 to 2014-09-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Version / remarks:
1998
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Bioassay-Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg/Germany
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: male: approx. 8 weeks, female: approx. 12 weeks
- Mean weight at study initiation: male: 231.6 g; female: 207.0 g
- Housing: Single housing in Makrolon cage, type III; Bedding H 15005-29; Ssniff, Spezialitäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany)
- Diet : ad libitum (VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: Tap water ad libitum
- Acclimation period: Acclimatization period of at least 5 days before the beginning of the experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 (Central air-conditioning)
- Humidity (%): 30 – 70
- Air changes (per hr): Approx. 10
- 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: clipped skin (dorsal and dorso-lateral parts of the trunk)
- % coverage: at least 10

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
- removal with warm water

TEST MATERIAL
- Amount applied: 2.14 mL/kg bw
- Constant volume or concentration used: yes

The test substance was administered undiluted.
Duration of exposure:
24 h
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: before administration, weekly, last day of observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross-pathology, skin observation

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
No signs of systemic toxicity were observed
The following test item-related local effects were recorded during the course of the study, local effects occurred within the first 10 days after administration:
- Very slight to moderate erythema (grade 1 to 3)
- Very slight to moderate edema (grade 1 to 3)
- Incrustations
- Scaling
Body weight:
The mean body weight of the male animals increased within the normal range throughout the study period. The body weight of the female animals increased within the normal range throughout the study period with one exception. One animal lost weight during the first week, probably due to the bandage procedure, but body weights were within the normal range during the second week.
Gross pathology:
No macroscopic pathologic abnormalities were observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met