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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
pre-GLP study, limited documented
Justification for type of information:
Information used for read across to Herbacet #1.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Results derived from a valid read across, with adequate and reliable documentation / justification.
Justification for type of information:
The read across justification is presented in the Acute Toxicity Endpoint summary. The corresponding documentation file is also attached there.
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Test material information:
Composition 1
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
680 mg/kg bw
Based on:
other: read across information
95% CL:
>= 440 - <= 1 050
Interpretation of results:
other: Acute oral toxicity Category 4
Remarks:
According to EU CLP Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
The acute oral LD50 for Herbacet #1 is considered to be 680 mg/kg bw, based on read across information from Ambrate.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
No details.
ENVIRONMENTAL CONDITIONS
No details.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No details.
Doses:
300, 600, 1220, and 5000 mg/kg bw
No. of animals per sex per dose:
10 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 11 days
- Frequency of observations and weighing: No data
- Necropsy performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
680 mg/kg bw
Based on:
test mat.
95% CL:
>= 440 - <= 1 050
Mortality:
300 mg/kg bw: 2/10 died; deaths were observed on day 1 and day 3.
600 mg/kg bw: 4/10 died; deaths were observed on day 1 (3 animals) and on day 11 (1 animal).
1220 mg/kg bw: 8/10 died; deaths were observed on day 1 (4 animals), day 2 (3 animals) and on day 10 (1 animal).
5000 mg/kg bw: 10/10 died; deaths were observed on day 1 (7 animals) and on day 2 (3 animals).
Clinical signs:
300 mg/kg bw: no clinical signs were observed.
600 mg/kg bw: lethargy, ptosis and piloerection.
1220 mg/kg bw: flaccid tone.
5000 mg/kg bw: lethargy, ataxia and coma.
Body weight:
No data.
Gross pathology:
Necropsy observations:
300 mg/kg bw: Intestines, red areas (1/10); intestines, yellow areas (2/10); liver, mottled (2/10); lungs, dark areas (4/10); kidneys dark (2/10)
600 mg/kg bw: Exudate, nose/mouth (1/10); intestines, yellow areas (3/10); intestines, bloated (1/10), liver dark (2/10); liver, mottled (3/10); lungs dark (1/10); lungs, dark areas (3/10); kidneys dark (3/10); kidneys, mottled (3/10); spleen large (1/10).
1220 mg/kg bw: Exudate, nose/mouth (1/10); exudate, anogenital (2/10), intestines, red areas (1/10); intestines, yellow areas (5/10); liver dark (2/10); liver, mottled (4/10); lungs dark (1/10); lungs, dark areas (4/10); kidneys dark (6/10); kidneys, mottled (2/10); spleen large (2/10).
5000 mg/kg bw: Exudate, nose/mouth (10/10); exudate, anogenital (3/10); intestines, red areas (1/10); intestines, yellow areas (10/10); intestines, bloated (7/10), liver, mottled (10/10); lungs dark (10/10); kidneys dark (10/10); blood in bladder (3/10).

Applicant's summary and conclusion

Interpretation of results:
other: Acute oral toxicity Category 4
Remarks:
According to EU CLP Regulation (EC) No. 1272/2008 and its amendments.
Conclusions:
The acute oral LD50 in rats was determined to be 680 mg/kg bw.
Executive summary:

In an acute oral toxicity study, performed similar to OECD TG 401 (pre-OECD, pre-GLP, rated Klimisch 2), 4 groups of 10 rats were orally exposed to the test substance and observed for signs of toxicity for a period of 11 days. At 300, 600, 1220 and 5000 mg/kg bw, respectively 2/10, 4/10, 8/10 and 10/10 animals died. Deaths occurred on day 1, 2, 3, 10 and 11. Clinical signs observed were lethargy, ptosis, piloerection, flaccid tone, ataxia and coma. At necropsy following effects were observed: exudate from nose/mouth and anogenital exudate, in the intestines red and yellow areas were observed and bloated intestines, dark livers and mottled livers, dark lungs and dark areas in the lungs, dark kidneys and mottled kidneys, large spleens, and blood in the bladder. Based on the results, a LD50 of 680 mg/kg bw was obtained in the acute oral toxicity study with rats.