Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 May 1994 to 24 May 1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
(1987)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Version / remarks:
(1984)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.1175 (Acute Oral Toxicity)
Version / remarks:
(1989)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 59 NohSan No. 4200 (Guidance on toxicology study data for application of agriculture chemical registration) (1985)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Technical Grade MKH 3586
- Substance type:
- Physical state: Beige powder
- Analytical purity: 97.8 - 98.2%
- Purity test date: 17 Jun 1994
- Lot/batch No.: 17004/93
- Expiration date of the lot/batch: 6 months from date of purity testing

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% CMC and 0.4 Tween 80
Doses:
Actual doses:
Males: 0, 98.4, 252, 816, 978, 1334, 1710, 3388, 5210 mg/kg
Females: 0, 98.4, 252, 816, 1218, 1710, 3388, 5210 mg/kg
No. of animals per sex per dose:
5 animals/sex/dose
Control animals:
yes

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1 300 mg/kg bw
95% CL:
ca. 1 085 - ca. 1 639
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 1 015 mg/kg bw
95% CL:
ca. 653 - ca. 1 395

Applicant's summary and conclusion

Conclusions:
The acute oral LD50 (with 95% confidence limits) for male and females was 1300 (1085 - 1639) and 1015 (653 - 1395) mg/kg respectively.
Executive summary:

An acute oral toxicity test (standard acute method) was conducted with rats to determine the potential for MKH 3586 to produce toxicity from a single doseviathe oral route.

 

Five animals/sex were dose at levels of 0, 100, 250, 800, 1000, 1300, 1600, 3200 or 5000 mg/kg for males or doses of 0, 100, 250, 800, 1200, 1600, 3200 or 5000 mg/kg for females. All animals were observed for mortality, signs of gross toxicity, and behavioural changes at least once daily for 14 days after dosing or until death occurred. Prominent clinical signs of toxicity included (but were not limited to) decreased activity, convulsions, increased lacrimation and animals jumping when touched. Observations noted at necropsy included reddened lungs and blackened zones in the glandular stomach mucosa in all animals which did not survive to the scheduled necropsy.

 

The acute oral LD50 (with 95% confidence limits) for male and females was 1300 (1085 - 1639) and 1015 (653 - 1395) mg/kg respectively.