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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 July 1994 to 10 August 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 402 (Acute Dermal Toxicity)
Version / remarks:
(1987)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
Version / remarks:
(1984)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.1100 (Acute Dermal 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:
standard acute method
Limit test:
yes

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
- Physical state: Beige power
- 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 purity test date

Test animals

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

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Duration of exposure:
24 hours
Doses:
0, 2000 mg/kg
No. of animals per sex per dose:
6 animals/sex/dose group
Control animals:
yes, concurrent no treatment

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
other: no mortality observed

Any other information on results incl. tables

OBSERVATIONS:

Clinical signs of toxicity:

No test material related signs of toxicity were observed

 

Mortality:

All animals survived to the scheduled necropsy

 

Bodyweight and bodyweight gain:

No test material related changes were observed

 

Sacrifice and Gross Pathology:

No gross lesions attributed to the test material were observed

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the single dose acute dermal LD50 of MKH 3586 is greater than 2000 mg/kg in male and female rats.
Executive summary:

An acute dermal toxicity test was conducted with rats to determine the potential for MKH 3586 to produce toxicity from a single topical application.

 

Two thousand milligrams of the test material/kg was applied to the skin of 12 healthy rats for 24 hours (6/sex). A concurrent control group of the same size were also used (not stated if these were dosed with vehicle or not). The animals were observed for mortality, signs of gross toxicity, and behavioural changes at least once daily for 14 days. Body weights were recorded prior to application and again on Days 7 and 14 (termination). Necropsies were performed on all animals at terminal sacrifice.

 

All animals survived, gained body weight and appeared active and healthy during the study. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.

 

Under the conditions of this study, the single dose acute dermal LD50 of MKH 3586 is greater than 2000 mg/kg in male and female rats.