Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 28 June 1988 to 5 August 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-2 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Physical state: white powder
- Analytical purity: 99.6%

- Lot/batch No.: AGR 240043

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazelton Dutchland, Inc, Denver, PA

- Weight at study initiation: 2.8 to 3.1

- Housing: Individually
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow #5322
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: two weeks

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk

- Type of wrap if used: Gauze dressing and non-irritating tape, and plastic wrap, with five mL of distilled water injected under the cuff to ensure sufficient skin contact; plastic warp was covered by a cloth bandage taped securely to the fur.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with mild soap and water and dried with soft disposable towel
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg of test material per kg body weight
Duration of exposure:
24 hours
Doses:
2000 mg test material per kg body weight
No. of animals per sex per dose:
5 animals total
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: weighed on day of treatment and on test days 2, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Means and standard deviations were calculated for body weights, data were evaluated for statistical outliers.

Results and discussion

Preliminary study:
no information
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no morality
Clinical signs:
No effect of dermal test site or any other organ at necropsy.
Body weight:
All rabbits gained weight by study termination.
Gross pathology:
No effect of dermal test site or any other organ at necropsy.
Other findings:
No information

Applicant's summary and conclusion

Interpretation of results:
other: acute dermal toxicity classified as low
Remarks:
Criteria used for interpretation of results: US EPA pesticides
Conclusions:
No LD50 could be determined at or below 2000 mg/kg bw. Acute dermal toxicity of XRD-498 was categorized as low.
Executive summary:

XRD-498 was evaluated for acute dermal toxicity in New Zealand White rabbits. Five rabbits per sex received a single dermal 24 -hour exposure to 2000 mg/kg of XRD-498. Parameters examined during the two-week observation period included body weights and in-life clinical observations. All animals were examined for gross pathologic changes. All animals survived the 2000 mg/kg limit test established by the guideline and therefore no other dose level was tested. All animals were in apparent good health throughout the study and gained weight by study termination. There was no effect atthe dermal test site or any other organ at necropsy. It was therefore concluded that under the conditions of this study, the acute dermal LD50 of XRD-498 was greater than 2000 mg/kg. Based on these results, the acute dermal toxicity of XRD-498 was categorized as low.