[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

9.4.2009 - 29.4.2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

1998

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1992

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: MAFF Japan Agricultural Chemicals Regulation Laws Notification 12 Nousan 8147

Version / remarks:

2000

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Amino-5-cyano-N,3-dimethylbenzamide

Cas Number:

890707-29-6

Molecular formula:

C10H11N3O

IUPAC Name:

2-Amino-5-cyano-N,3-dimethylbenzamide

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Raleigh, North Carolina
- Age at study initiation: Approximately 9 weeks old
- Weight at study initiation: 297.1–336.0 g for males; 204.2–239.6 g for females
- Housing: Animals were housed singly in polycarbonate pans that contained bedding and enrichment (e.g., nestlet or nylabone).
- Diet: PMI Nutrition International, LLC Certified Rodent LabDiet (#5002), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 6 days

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

Administration / exposure

Type of coverage:

semiocclusive

Details on dermal exposure:

Approximately 24 hours before dosing, the fur of each animal was closely shaved to expose the back from the scapular to the lumbar region (approximately 10% of each animal’s body surface area). A single dose of the test substance, moistened with approximately 0.5 mL of deionized water, was applied to the intact skin of 5 males and 5 females. The application site was covered with a porous gauze dressing. After 24 hours, excess test substance was washed from the dorsal skin of each animal with warm water and the skin was dried with a paper towel.

Duration of exposure:

24 h

Doses:

- 5000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
Animals were observed for mortality and signs of illness, injury, or abnormal behavior daily. Observations for clinical signs and dermal irritation were made daily (weekends excluded). Dermal effects were scored according to the Draize Scale. The animals were weighed on test Days 0, 7 and 14.

- Necropsy of survivors performed: yes
All animals were euthanised and necropsied to detect grossly observable evidence of organ or tissue damage.

Statistics:

The data did not warrant statistical analysis.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities occurred.

Clinical signs:

other:

Body weight:

other body weight observations

Remarks:

There were no test substance-related body weight effects noted.

Gross pathology:

One gross lesion was present in one rat. The gross lesion observed was skin ulcer/erosion on the neck. No other gross lesions were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under conditions of this study, the dermal LD50 for the test substance was greater than 5000 mg/kg body weight when applied to the skin of male and female rats for 24 hours.

Executive summary:

The acute dermal toxicity of the test substance was investigated according to OECD Guideline 402.

A single dose of the test substance, moistened with approximately 0.5 mL of deionized water, was applied to the shaved, intact skin of 5 male and 5 female rats at a dose of 5000 mg/kg body weight. The application site covered approximately 10% of each animal’s body surface area. The application site was semi-occluded for 24 hours after which the test substance was removed. The rats were observed for clinical signs, body weight effects, dermal effects, and mortality for 14 days following application. All animals were examined for gross pathological changes.

No mortalities were observed. The rats exhibited no clinical signs of systemic toxicity during the study.  There were no test substance-related body weight effects noted. One gross lesion was present one rat. The gross lesion observed was skin ulcer/erosion on the neck. No other gross lesions were observed.

Under the conditions of this study, the skin absorption LD50 for the test substance was greater than 5000 mg/kg of body weight when applied to the skin of male and female rats for 24 hours.