Registration Dossier

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:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
According to "Standard Operating Procedure No CT20-090/01" as cited in text, number of animals, analytical purity of test substance and experimental conditions not specified
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Alderley Park, SPF-derived, albino strain
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult, not further specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Material used as a 20% (w/v) emulsion in corn oil for a dose of 2000 mg/kg bw and as a 15%, 13.5%, 12.5% 10% and 5% (w/v) emulsion in corn oil for doses of 1500, 1350, 1250, 1000 and 500 mg/kg bw respectively.
Doses:
500, 1000, 1250, 1350, 1500 and 2000 mg/kg bw
No. of animals per sex per dose:
No data, but results of mortalities indicate that ≥5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: Up to 8 days reported
- Other examinations performed: clinical signs
Statistics:
The LD50 was calculated by the logit method (Berkson, 1944)

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
1 500 mg/kg bw
Based on:
test mat.
95% CL:
1 100 - 2 000
Sex:
female
Dose descriptor:
LD50
Effect level:
1 300 mg/kg bw
Based on:
test mat.
95% CL:
1 250 - 2 000
Mortality:
2000 mg/kg bw: 4 male and 5 female dead by day 6
1500 mg/kg bw: 2 male and 4 female dead by day 8
1350 mg/kg bw: Only females treated, all dead by day 4
1250 mg/kg bw: Only females treated, no deaths
1000 mg/kg bw: 1 male dead by day 4
500 mg/kg bw: No deaths
Clinical signs:
2000 mg/kg bw: Subdued appearance, piloerection, chromodacryorrhoea, scouring, curvature of spine, laboured respiration and a red stain around the snout
1500 mg/kg bw: Slight piloerection, incontinence, salivation and an ungroomed appearance
1350, 1250, 1000 and 500mg/kg bw: Incontinence, salivation, lacrymation and laboured respiration
Body weight:
No data
Gross pathology:
No data

Any other information on results incl. tables

Clinical signs observed in this study are reported to be indicative of excessive para-sympathetic nervous activity. Atmer 163 with a LD50 of 1500 mg/kg bw in male and 1300 mg/kg bw in female rats by oral route has to be classified:

CLP: Category 4, H302 (harmful if swallowed)

DSD: Xn, R22 (harmful)

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria