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Toxicological information

Acute Toxicity: dermal

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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: Well conducted and documented study, fully adequate for assessment. Performed guideline conform and according to GLP in a recognised contract research organisation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
small deviations without effect on study performance and result.
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Bis(pentan-2,4-dionato)calcium
- Substance type: industrial chemical
- Physical state: powder
- Analytical purity: ca. 99.6%
- Impurities (identity and concentrations): water ca. 0.4%
- Lot/batch No.: EPC-102-41-1
- Expiration date of the lot/batch: April 2017
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 170 - 256 g; females: 246 - 287 g
- Fasting period before study: no
- Diet (pelleted): ad libitum
- Water (tap water): ad libitum
- Temperature: 22 +/- 2°C
- Humidity: 45 - 65%
- Room air change: approx. 10 times per hour
- Light/dark cycle: 12/12 h

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: powder was moistened with water
Details on dermal exposure:
TEST SITE
- Area of exposure: > 10% of body surface; the dorsal area of the trunk was shaven prior to application

REMOVAL OF TEST SUBSTANCE
- Washing (if done): removal of remnants on the skin with water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 per sex and dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: 8 days before application, on the day of application, 8 and 15 days after application
- Frequency of observations: 4 times on the day of treatment, once daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:
dose selection was based on LD50 values determined with the read-across substance 2,4-pentanedione.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
No test item related clinical findings were noted during application and until the end of the observation period.
Body weight:
Normal body weight gain.
Gross pathology:
In females no macroscopic findings were noted during necropsy. Application sites were without any findings, as well as subcutaneous tissue.
In males macroscopic findings were assumed to have been incidental and not test item related. Application sites were without any findings, as well as subcutaneous tissue.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dermal LD50 in rats > 2000 mg/kg body weight