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Toxicological information

Acute Toxicity: oral

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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was selected as a key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment. The justification for read-across is attached in IUCLID5.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: not reported as such

Test animals

Species:
mouse
Strain:
other: Crl:CD1(ICR)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10 weeks
- Weight at study initiation: 24-27 g
- Fasting period before study: yes; 3-4 hours prior to dosing
- Housing: singly in polycarbonate pans that contained bedding with enrichment (i.e., Shepherd’s™ Cob + PLUS™).
- Diet (e.g. ad libitum): ad libitum except for fasting period prior to dosing; food was returned to the mice approximately 1 hour after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26°C
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: Not Reported
Doses:
5000 mg/kg and 10000 mg/kg of the formulation.
No. of animals per sex per dose:
Three females, each at a dose level of 5000 mg/kg. One mouse was initially dosed. The remaining 2 mice were simultaneously dosed
2 days (at least 48 hours) later. An additional mouse was treated at a dose level of 10000 mg/kg of the formulation.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: All animals were observed for mortality, signs of gross toxicity, and behavioural changes once during the first 30 minutes after dosing and 2 more times on the day of dosing, and once each day thereafter for 14 days after dosing.
-Frequency of weighing: prior to fasting and administration, and again on Days 7 and 14 (termination) following dosing.
- Necropsy of survivors performed: yes, on all animals at terminal sacrifice to detect grossly observable evidence of organ or tissue damage.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 other: mg/kg bw . Additionally, no mortality, clinical signs, or body weight losses were observed in a mouse dosed at 10000 mg/kg.
Mortality:
No deaths occurred.
Clinical signs:
The mice exhibited no clinical signs.
Body weight:
No biologically relevant body weight losses occurred after dosing.
Gross pathology:
No gross lesions were present in the mice at necropsy.

Any other information on results incl. tables

The aqueous dispersion of the test substance was administered directly without correction for active ingredients since the product does not exist as solids alone and is always transported and used as the aqueous dispersion. The material was not toxic via the oral route of exposure as evidenced by the LD50 of > 5000 mg/kg. Additionally, no mortality, clinical signs, or body weight losses were observed in a mouse dosed at 10000 mg/kg.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
LD50 (female mice) > 5000 mg/kg. Additionally, no mortality, clinical signs, or body weight losses were observed in a mouse dosed at 10000 mg/kg.
Executive summary:

A single dose of test substance was administered by oral gavage to 3 fasted female mice at a dose of 5000 mg/kg. One mouse was initially dosed. The remaining 2 mice were simultaneously dosed 2 days (at least 48 hours) later. An additional mouse was treated at a dose of 10,000 mg/kg. The mice were observed for mortality, body weight effects, and clinical signs for 14 days after dosing. All mice were necropsied to detect grossly observable evidence of organ or tissue damage. No deaths occurred. The mice exhibited no clinical signs or biologically relevant body weight losses during the study. No gross lesions were present in the mice at necropsy. Under the conditions of this study, the oral LD50 was greater than 5000 mg/kg for female mice based on the limit test conducted at 5000 mg/kg. Additionally, no mortality, clinical signs, or body weight losses were observed in a mouse dosed at 10,000 mg/kg.