Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
28 Jul - 26 Sep 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance..

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
The Swiss GLP Monitoring Authorities, Bern, Switzerland
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
736150-63-3
EC Number:
616-005-1
Cas Number:
736150-63-3
Molecular formula:
C25H46 O6; C27H48O8
IUPAC Name:
736150-63-3
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: 86%
- Lot/batch No.: 10102
- Expiration date of the lot/batch: 2033-11-22
- Storage condition of test material: in the original container, at room temperature (range of 20 ± 3 °C), away from direct sunlight

Test animals

Species:
rat
Strain:
other: HanBrl: WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Füllinsdorf, Switzerland
- Age at study initiation: 8 weeks (males), 12 weeks (females)
- Weight at study initiation: 230.6 - 263.1 (males) and 195.7 - 204.4 (females)
- Housing: During acclimatisation animals were housed in groups of five per sex in Makrolon IV cages with standard softwood bedding. Animals were housed individually in Makrolon III cages with standard softwood bedding (Lignocel, Schill AG, Muttenz, Switzerland) during treatment and observation.
- Diet: pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 4/03 (Provimi Kliba AG, Kaiseraugust, Switzerland), ad libitum
- Water: community tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
- Other: music during the light period

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
corn oil
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped skin on the back of the animals
- % coverage: 10
- Type of wrap if used: The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw

VEHICLE
- Lot/batch no.: 37255780
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed daily during acclimatisation and twice daily during Days 1-15.
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs were observed daily during acclimatisation and at approximately 1, 2, 3 and 5 h after administration on test Day 1. Afterwards, animals were observed once daily during Days 2-15. Body weights were examined on test Day 1 (prior to administration) and on Days 8 and 15.

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 during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
Body weight gains were within the normal ranges in males and females during the whole study period.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified