2-ketogluconic acid, calcium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ketogluconic acid, calcium salt

EC Number:

919-553-2

Cas Number:

28098-92-2

Molecular formula:

C6H10O7.xCa

IUPAC Name:

2-ketogluconic acid, calcium salt

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The animals of the treated group, received an effective dose of 2000 mg/kg body weight of the test
item Acide 2-cetogluconique, sel de calcium, diluted in distilled water and administered by gavage
under a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an
oesophageal metal canula.

Doses:

2000mg/kg

No. of animals per sex per dose:

6

Control animals:

yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No clinical signs related to the administration of the test item were observed.

Gross pathology:

The macroscopical examination of the animals at the end of the study did not reveal treatment-related
changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item Acide 2-cetogluconique, sel de calcium was administered by oral route to a group of 6
female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol
was established on the basis of the official method as defined in the O.E.C.D. guideline N° 423 dated
December 17th, 2001 and the test method B.1ter of the Council regulation No 440/2008.
No mortality occurred during the study.
No clinical signs related to the administration of the test item were observed.
The body weight evolution of the animals remained normal throughout the study.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related
changes.
In conclusion, the LD50 of the test item Acide 2-cetogluconique, sel de calcium is higher than 2000
mg/kg body weight by oral route in the rat.
In accordance with the OECD guideline n°423, the LD50 of the test item may be considered higher
than 5000 mg/kg body weight by oral route in the rat.
According to the criteria for classification, packaging and labelling of dangerous substances and
preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item Acide
2-cetogluconique, sel de calcium must not be classified. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (Regulation (EC) No 1272/2008), the test item
must not be classified in category 4. No signal word and hazard statement are required.