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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
Cited as Directive 92/69/EEC, B.3
Deviations:
no
Qualifier:
according to
Guideline:
EPA OTS 798.1100 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio, USA
- Age at study initiation: no data
- Weight at study initiation: 2.355 +/- 0.067 kg for males and 2.416 +/-0.186 kg for females
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): Agway Prolab Rabbit Feed
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
On the day prior to dosing, the fur was clipped from the dorsal area of the trunk of each animal using a small animal clipper. The clipped area measured approximately 20 cm x 12 cm and constituted approximately 10% of the animal's total body surface. Care was taken during clipping to avoid accidentai abrasion to the skin. On the following day, each rabbit was weighed and the test article was applied uniformly over the clipped area at the appropriate test article dose. Each animal's dose was contained at the area of application using an 8 ply gauze dressing taped in place which was moistened with an equivalent volume of distilled water. A plastic wrap followed by an elastic wrap was then positioned over the trunk of each animal and both secured in place using tape. After an exposure period of 24 hours, the elastic wrap, plastic wrap and gauze dressing were removed. The exposure site on each animal was rinsed with gauze moistened in distilled water to remove residual test article.
Duration of exposure:
24 hrs
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The animals were observed frequently on the day of dosing and once daily thereafter for the duration of the study (day 15). Mortality checks were performed twice daily. Individual body weights were determined and recorded on days 1, 8 and 15. All animals were subjected to a gross necropsy examination at the time of scheduled sacrifice (sodium pentobarbital).
Statistics:
Not appropriate

Results and discussion

Preliminary study:
no data
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality occurred during the study
Clinical signs:
The most notable clinical signs were generally limited to transient dermal irritation at the site of test article application
Body weight:
Body weight gain was exhibited by all animals during the study
Gross pathology:
At necropsy on day 15, the pancreas or pancreatic lymph nodes of 4/10 animais were noted to have an abnormal red discoloration. The cause of this finding could not be determined. No significant internal abnormalities were observed in the remaining animals at necropsy
Other findings:
no

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
he acute dermal LD50 of 1,3-Diphenyl Guanidine was determined to be greater than 2000 mg/kg in the rabbit
Executive summary:

The acute dermal toxicity of 1,3-Diphenyl Guanidine (DPG) was evaluated in rabbits in a study performed following EU method B. 3. A limit test was performed in which one group of five male and five female rabbits received a single dermal application of DPG at a dose of 2000 mg/kg body weight. Following dosing, the rabbits were observed daily and weighed weekly. A gross necropsy examination was performed on all test animals at the time of death or scheduled euthanasia (day 15).

No mortality occurred during the study. The most notable clinical signs were generally limited to transient dermal irritation at the site of test article application. Body weight gain was exhibited by all animals during the study. At necropsy on day 15, the pancreas or pancreatic lymph nodes of 4/10 animals were noted to have an abnormal red discoloration. The cause of this finding could not be determined. No significant internai abnormalities were observed in the remaining animals at necropsy.

The acute dermal LD0 of 1,3-Diphenyl Guanidine was determined to be greater than 2000 mg/kg in the rabbit.