sodium/triethanolamine- 6-(2,5-dioxo-3-C12-18-alkenyl(even and odd, branched, unsaturated)-pyrrolidin-1-yl)hexanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1991-03-04 to 1991 03-26

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Rationale for the reliability: Guideline study; well-performed and well-documented; read-across Rational for the justification: the grouped substances differ only that the read-across substance is a weak acid and that the registration substance is the corresponding salt. When dissolved in biological fluid, the regitration substance will be converted to the read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(Pentapropylensuccinimido)-caproic acid

IUPAC Name:

(Pentapropylensuccinimido)-caproic acid

Constituent 2

Reference substance name:

6-[3-(C14-C18)-alkenyl(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid

EC Number:

800-767-9

Cas Number:

1424148-94-6

Molecular formula:

C22H37NO4 - C28H49NO4

IUPAC Name:

6-[3-(C14-C18)-alkenyl(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Preliminary study; for each dose levels of 500, 1000 and 2000 mg/kg bw one male and one female rats were used. No significant effects were found.

Results and discussion

Preliminary study:

No effect found

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality found

Clinical signs:

Within 24 hours: increased respiration rate, squatting posture, sunken flanks, stilted and uncordinated gait, decreased spantaenous activity, bristling coat
After 24 hours

Body weight:

Not impaired in the observation period of 14 days

Gross pathology:

No effect

Any other information on results incl. tables

Justification for the read-across using (Pentapropylensuccinimido)-caproic acid as supporting substance.

The read-across supporting substance is a weak acid and the registration substance is the corresponding weak base. When dissolved in aqueous system or in the biological fluid the registration substance will be dissociated and converted in the read-across supporting substance and sodium ion/triethanolamine ammonium, thereby explaning the expected comparability. The counter ions of the registration substance, sodium ion and triethanolammonium ions are of limited toxicological meaning for the endpoint acute toxicity.

Upon exposure to the registration substancel the conversion to the read-across supporting substance is likely to occur prior to adsorption. It means, the conversion occurs mostly already in the gastro-intestinal tract, in the fluid of the respiratory tract and during the penetration of the upper layer of epidermis for uptake routes oral, inhalative and dermal respectively.

It is therefore apparent that there should be no potency difference on bases of molar dose. For obtaining the proper LD50 for the registration substance, the only factor to be considered is the molecular mass difference (530 g/mol vs ca. 420 g/mol).

The provided dose level of 2000 mg/kg bw of the read-across supporting substance corresponds to 2500 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral toxicity of the read-across supporting substance was investigated according to the OECD Guideline 401. At dose of 2000 mg/kg bw no significant effect was found.

Executive summary:

The acute oral toxicity of the read-across supporting substance was investigated according to the OECD Guideline 401. At dose of 2000 mg/kg bw no significant effect was found. The doses provided equals 2500 mg/kg bw of the registration substance.