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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 29, 1998 - September 07, 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP-guideline study of a very similar substance (BRUGGOLITE FF6): This study was conducted following OECD-guideline 401. The study was performed in accordance with the principles of GLP (§19a, ChemG). Similarity of BLANCOLEN HP and BLANCOLEN HP BRUGGOLITE FF6 is a multi-constituent substance composed of • Disodium hydroxysulfinateacetate • Disodium hydroxysulfonateacetate • Sodium sulphite (as impurity) BLANCOLEN HP is the mono-constituent substance • Disodium hydroxysulfonateacetate During the manufacturing of BRUGGOLITE FF6 (the desired molecule is disodium hydroxysulfinate-acetate) the formation of disodium hydroxysulfonateacetate cannot be avoided. Sodium sulphite is an impurity resulting from the starting material. BLANCOLE HP can be obtained by a similar reaction as a mono-constituent substance. Especially in aqueous media, disodium hydroxysulfinateacetate of BRUGGOLITE FF6 is easily oxidized; the primarily resulting product is disodium hydroxysulfonateacetate. Therefore, practically no significant differences will occur between testing of BRUGGOLITE FF6 and BLANCOLEN HP in aqueous systems if any contributions of sodium sulphite to the result can be neglected. Moreover disodium hydroxysulfinateacetate is the stronger reducing agent and is expected to induce more severe effects compared to the hydroxysulfonateacetate.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous solution
Doses:
2000 mg/kgbw
No. of animals per sex per dose:
5 males
5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Any other information on results incl. tables

A single dose of the aqueous solution (6 g ad. 30 ml) was administered after an overnight fasting by oral gavage, using a metal catheter and disposable plastic syrings, with a constant volume of 1 ml/100 gbw to each of 5 males and 5 females. Individual doses were adjusted according to the body weight on the day of administration.

No animal died after single oral administration of 2000 mg/kgbw of BRUGGOLITE FF6. The LD50 rat is > 2000 mg/kgbw

Applicant's summary and conclusion

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