Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Principles of method if other than guideline:
Male and female rhesus monkeys were dosed by means of an orogastric intubation tube with doses between 800 and 3200 mg/kg.
GLP compliance:
no
Test type:
other: acute oral toxicity
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium [2-[(2,6-dichlorophenyl)amino]phenyl]acetate
EC Number:
239-346-4
EC Name:
Sodium [2-[(2,6-dichlorophenyl)amino]phenyl]acetate
Cas Number:
15307-79-6
Molecular formula:
C14H11Cl2NO2.Na
IUPAC Name:
sodium {2-[(2,6-dichlorophenyl)amino]phenyl}acetate

Test animals

Species:
primate
Strain:
other: rhesus monkey
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
800 mg/kg bw , 1131 mg/kg bw, 1600 mg/kg bw, 2262 mg/kg bw, 3200 mg/kg bw
No. of animals per sex per dose:
800 mg/kg bw: 1
1131-3200 mg/kg bw: 4
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 200 mg/kg bw
Based on:
test mat.
95% CL:
> 1 680 - < 4 720

Any other information on results incl. tables

Two monkeys at 3200 mg/kg bw and one monkey at 2262 mg/kg bw died spontaneously between 6 h and 5 days post-dose. Animals dying spontaneously showed some or all of the following signs: emesis, ataxia, excessive salivation, vocalization, partial or complete loss of activity, rectal bleeding and, usually, coma before death.

Applicant's summary and conclusion

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