Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
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 Read-across justification: the registration substance and the read-across supporting substance belong to homologous series of (Polypropenyl succinimido)- caproic acid

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

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 approach using (Pentapropenyl succinimido)-caproic acid as supporting substance:

The registration substance (Tetrapropenyl succinimido)-caproic acid and proposed supporting substance (Pentapropenyl succinimido)-caproic acid are homolog series of (Polypropenyl succinimido)-caproic acid and can be considered as to belong to "chain lenght category". Similar metabolite fates and the same mode of action can be presumed.

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.