Bis(pentane-2,4-dionato)calcium

Acute Toxicity: dermal

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

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

small deviations without effect on study performance and result.

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(pentane-2,4-dionato)calcium

EC Number:

243-001-3

EC Name:

Bis(pentane-2,4-dionato)calcium

Cas Number:

19372-44-2

Molecular formula:

C10H14CaO4

IUPAC Name:

calcium bis[(2Z)-4-oxopent-2-en-2-olate]

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 or test system 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:

other: No test item related clinical findings were noted during application and until the end of the observation period.

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