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Administrative data

Description of key information

Atmer 163 is harmful if applied by the oral route. Inhalative and dermal route haven't been evaluated due to Atmer 163's corrosive character.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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
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)
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

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)

Interpretation of results:
Category 4 based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 300 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin corrosion/irritation studies on rabbit skin revealed that Atmer 163 is classified as corrosive to the skin. Although a study for oral toxicity of Atmer 163 was performed, acute toxicity studies do not generally need to be conducted according to Annex VIII 8.5 column 2 if the substance is classified as corrosive to the skin.

An acute oral toxicity study has been performed with Alderley Park, SPF-derived, albino strain rats according to Standard Operating Procedure No CT20-090/01 and similar to OECD guideline 401 (CTL/T/1357). The animals were treated with 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. Animals were observed up to 8 days and clinical signs reported. At 2000 mg/kg bw 4 male and 5 female were dead by day 6 and animals showed subdued appearance, piloerection, chromodacryorrhoea, scouring, curvature of spine, laboured respiration and a red stain around the snout. At 1500 mg/kg bw 2 male and 4 female were dead by day 8 and slight piloerection, incontinence, salivation and an ungroomed appearance were observed. At 1350 (only females treated, all dead by day 4), 1250 (only females treated, no deaths), 1000 (1 male dead by day 4) and 500 mg/kg bw (no deaths) incontinence, salivation, lacrymation and laboured respiration occurred. 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.

 


Justification for selection of acute toxicity – oral endpoint
The reliable key study was choosen.

Justification for selection of acute toxicity – inhalation endpoint
No study required due to Atmer 163's corrosive character.

Justification for selection of acute toxicity – dermal endpoint
No study required due to Atmer 163's corrosive character.

Justification for classification or non-classification

An acute oral toxicity study in rats yielded in a LD50 of 1300 mg/kg bw for female and 1500 mg/kg bw for male rats. According to CLP Atmer 163 has to be classified:

CLP: Category 4, H302